WASHINGTON – All transcatheter aortic valve replacement devices generate debris into the bloodstream, including debris larger than 1 mm, but the amount of the debris differs between devices, according to a study based on collections from a cerebral embolic protection system.

“The quantity of the debris measured by different methods and techniques revealed more debris in patients receiving the Evolut R or Lotus TAVR [transcatheter aortic valve replacement] devices than in patients receiving a Sapien 3 or Sapien XT prosthesis,” reported Tobias Schmidt, MD, a cardiologist at Asklepios Klinik St. Georg, Hamburg, Germany.

SOURCE: Schmidt T et al. CROI 2018.

WASHINGTON – All transcatheter aortic valve replacement devices generate debris into the bloodstream, including debris larger than 1 mm, but the amount of the debris differs between devices, according to a study based on collections from a cerebral embolic protection system.

“The quantity of the debris measured by different methods and techniques revealed more debris in patients receiving the Evolut R or Lotus TAVR [transcatheter aortic valve replacement] devices than in patients receiving a Sapien 3 or Sapien XT prosthesis,” reported Tobias Schmidt, MD, a cardiologist at Asklepios Klinik St. Georg, Hamburg, Germany.

SOURCE: Schmidt T et al. CROI 2018.

WASHINGTON – All transcatheter aortic valve replacement devices generate debris into the bloodstream, including debris larger than 1 mm, but the amount of the debris differs between devices, according to a study based on collections from a cerebral embolic protection system.

“The quantity of the debris measured by different methods and techniques revealed more debris in patients receiving the Evolut R or Lotus TAVR [transcatheter aortic valve replacement] devices than in patients receiving a Sapien 3 or Sapien XT prosthesis,” reported Tobias Schmidt, MD, a cardiologist at Asklepios Klinik St. Georg, Hamburg, Germany.

SOURCE: Schmidt T et al. CROI 2018.

Benjamin Chaigne-Delalande

LISBON—A review of recent studies has revealed a “significant burden” of mortality related to post-transplant lymphoproliferative disorder (PTLD), according to researchers.

Of the 120 PTLD patients studied, 64% died and 42.5% died with PTLD.

The median time from hematopoietic stem cell transplant (HSCT) to the development of PTLD was about 9 weeks in children and 11 weeks in adults.

The median time from PTLD diagnosis to death was about 6 weeks in adults and 8 weeks in children.

These findings were presented at 44th Annual Meeting of the EBMT (abstract A219).

The research was funded by Atara Biotherapeutics, Inc., which is developing tabelecleucel (formerly ATA129), a T-cell immunotherapy intended to treat patients with Epstein-Barr virus-associated PTLD who have failed treatment with rituximab.

The review included 9 articles, published in 2005 and later, detailing studies of patients who developed PTLD after HSCT.

There were 120 patients. They had a mean age of 28.97, 67% were male, and 79% had received rituximab.

The 31 pediatric patients had a mean age of 9.84, 81% were male, and 74% had received rituximab. The 89 adult patients had a mean age of 35.63, 62% were male, and 81% had received rituximab.

Among the 16 pediatric patients with available data, the median time from HSCT to PTLD diagnosis was 65 days, and the mean was 138 days.

For the 59 adults with available data, the median time from HSCT to PTLD was 76 days, and the mean was 132 days.

The all-cause mortality rate was 64% in the entire population (77/120), 71% in children (22/31), and 62% in adults (55/89).

Overall, 42.5% of patients (51/120) died with PTLD—35.5% of children (11/31) and 44.9% of adults (40/89).

Among the patients who died with PTLD, the median time from PTLD diagnosis to death was 55 days for children and 40 days for adults. The mean time from PTLD to death was 71 days and 51 days, respectively.

There were 110 patients with available overall survival data. The median survival time from PTLD diagnosis was 116 days in the entire cohort, 153 days in children, and 92 days in adults.

“Patients with PTLD following [HSCT] experience high mortality rates under the current standard of care due to aggressive disease that often rapidly progresses to death after diagnosis,” said Chris Haqq, MD, PhD, of Atara Biotherapeutics.

“Children and relatively young adults in their prime working years are disproportionately affected. Atara is dedicated to progressing tab‑cel™ development in the ongoing phase 3 clinical studies to potentially address the compelling medical need for patients with this life-threatening condition.”

Benjamin Chaigne-Delalande

LISBON—A review of recent studies has revealed a “significant burden” of mortality related to post-transplant lymphoproliferative disorder (PTLD), according to researchers.

Of the 120 PTLD patients studied, 64% died and 42.5% died with PTLD.

The median time from hematopoietic stem cell transplant (HSCT) to the development of PTLD was about 9 weeks in children and 11 weeks in adults.

The median time from PTLD diagnosis to death was about 6 weeks in adults and 8 weeks in children.

These findings were presented at 44th Annual Meeting of the EBMT (abstract A219).

The research was funded by Atara Biotherapeutics, Inc., which is developing tabelecleucel (formerly ATA129), a T-cell immunotherapy intended to treat patients with Epstein-Barr virus-associated PTLD who have failed treatment with rituximab.

The review included 9 articles, published in 2005 and later, detailing studies of patients who developed PTLD after HSCT.

There were 120 patients. They had a mean age of 28.97, 67% were male, and 79% had received rituximab.

The 31 pediatric patients had a mean age of 9.84, 81% were male, and 74% had received rituximab. The 89 adult patients had a mean age of 35.63, 62% were male, and 81% had received rituximab.

Among the 16 pediatric patients with available data, the median time from HSCT to PTLD diagnosis was 65 days, and the mean was 138 days.

For the 59 adults with available data, the median time from HSCT to PTLD was 76 days, and the mean was 132 days.

The all-cause mortality rate was 64% in the entire population (77/120), 71% in children (22/31), and 62% in adults (55/89).

Overall, 42.5% of patients (51/120) died with PTLD—35.5% of children (11/31) and 44.9% of adults (40/89).

Among the patients who died with PTLD, the median time from PTLD diagnosis to death was 55 days for children and 40 days for adults. The mean time from PTLD to death was 71 days and 51 days, respectively.

There were 110 patients with available overall survival data. The median survival time from PTLD diagnosis was 116 days in the entire cohort, 153 days in children, and 92 days in adults.

“Patients with PTLD following [HSCT] experience high mortality rates under the current standard of care due to aggressive disease that often rapidly progresses to death after diagnosis,” said Chris Haqq, MD, PhD, of Atara Biotherapeutics.

“Children and relatively young adults in their prime working years are disproportionately affected. Atara is dedicated to progressing tab‑cel™ development in the ongoing phase 3 clinical studies to potentially address the compelling medical need for patients with this life-threatening condition.”

Benjamin Chaigne-Delalande

LISBON—A review of recent studies has revealed a “significant burden” of mortality related to post-transplant lymphoproliferative disorder (PTLD), according to researchers.

Of the 120 PTLD patients studied, 64% died and 42.5% died with PTLD.

The median time from hematopoietic stem cell transplant (HSCT) to the development of PTLD was about 9 weeks in children and 11 weeks in adults.

The median time from PTLD diagnosis to death was about 6 weeks in adults and 8 weeks in children.

These findings were presented at 44th Annual Meeting of the EBMT (abstract A219).

The research was funded by Atara Biotherapeutics, Inc., which is developing tabelecleucel (formerly ATA129), a T-cell immunotherapy intended to treat patients with Epstein-Barr virus-associated PTLD who have failed treatment with rituximab.

The review included 9 articles, published in 2005 and later, detailing studies of patients who developed PTLD after HSCT.

There were 120 patients. They had a mean age of 28.97, 67% were male, and 79% had received rituximab.

The 31 pediatric patients had a mean age of 9.84, 81% were male, and 74% had received rituximab. The 89 adult patients had a mean age of 35.63, 62% were male, and 81% had received rituximab.

Among the 16 pediatric patients with available data, the median time from HSCT to PTLD diagnosis was 65 days, and the mean was 138 days.

For the 59 adults with available data, the median time from HSCT to PTLD was 76 days, and the mean was 132 days.

The all-cause mortality rate was 64% in the entire population (77/120), 71% in children (22/31), and 62% in adults (55/89).

Overall, 42.5% of patients (51/120) died with PTLD—35.5% of children (11/31) and 44.9% of adults (40/89).

Among the patients who died with PTLD, the median time from PTLD diagnosis to death was 55 days for children and 40 days for adults. The mean time from PTLD to death was 71 days and 51 days, respectively.

There were 110 patients with available overall survival data. The median survival time from PTLD diagnosis was 116 days in the entire cohort, 153 days in children, and 92 days in adults.

“Patients with PTLD following [HSCT] experience high mortality rates under the current standard of care due to aggressive disease that often rapidly progresses to death after diagnosis,” said Chris Haqq, MD, PhD, of Atara Biotherapeutics.

“Children and relatively young adults in their prime working years are disproportionately affected. Atara is dedicated to progressing tab‑cel™ development in the ongoing phase 3 clinical studies to potentially address the compelling medical need for patients with this life-threatening condition.”

ORLANDO – Hospitals in the first quartile of short-term performance in treating heart failure patients had higher long-term survival rates for those patients, based on data from 317 hospitals that participated in a voluntary quality improvement program.

The burden of heart failure remains substantial in the United States, and health policies are increasingly focused on improving care for heart failure patients, said Ambarish Pandey, MD, of the University of Texas, Dallas, in a presentation at the annual meeting of the American College of Cardiology.

Heidi Splete/Frontline Medical News

SOURCE: Pandy A. ACC 2018.

ORLANDO – Hospitals in the first quartile of short-term performance in treating heart failure patients had higher long-term survival rates for those patients, based on data from 317 hospitals that participated in a voluntary quality improvement program.

The burden of heart failure remains substantial in the United States, and health policies are increasingly focused on improving care for heart failure patients, said Ambarish Pandey, MD, of the University of Texas, Dallas, in a presentation at the annual meeting of the American College of Cardiology.

Heidi Splete/Frontline Medical News

SOURCE: Pandy A. ACC 2018.

ORLANDO – Hospitals in the first quartile of short-term performance in treating heart failure patients had higher long-term survival rates for those patients, based on data from 317 hospitals that participated in a voluntary quality improvement program.

The burden of heart failure remains substantial in the United States, and health policies are increasingly focused on improving care for heart failure patients, said Ambarish Pandey, MD, of the University of Texas, Dallas, in a presentation at the annual meeting of the American College of Cardiology.

Heidi Splete/Frontline Medical News

SOURCE: Pandy A. ACC 2018.

When longitudinal melanonychia appears as a sharply demarcated pigment band of even width against normal nail in a child, Hutchinson’s sign with longitudinal brushy pigmentation may be a useful clinical pattern suggesting a diagnosis of nail matrix nevus rather than subungual melanoma, said Jae Ho Lee, MD, of Sungkyunkwan University, Seoul, South Korea, and associates.

In a study of biopsy-proven nail matrix nevi (NMN) in 20 children and 8 adults, average melanonychia width was 3.5 times greater in children than in adults, with 14 children having melanonychia greater than 20% the width of the nail, compared with 2 adults. Total melanonychia occurred just twice, in two children. A total of 12 children had nail dystrophy, while none of the adults did; nail dystrophy was more frequent in wider lesions.

Hutchinson’s sign was seen in seven pediatric patients, but no adult patients. In most cases, Hutchinson’s sign had hyponychial pigmentation, and on dermoscopy showed a pigment pattern presenting longitudinally and resembling a brush mark (longitudinal brushy pigmentation or LBP). LBP of nail matrix nevi is different from the Hutchinson’s sign that occurs in subungual melanoma (SUM), where it is typically a “haphazard pigmentation pattern involving periungual skin.

“We propose that Hutchinson’s sign occurs more commonly in pediatric NMN than in adult NMN, and that the presence of the LBP pattern can help distinguish pediatric NMN from SUM,” the investigators said.

Histologically, the biopsies of the NMN in this study showed some important differences from known SUM histology. All the study biopsies “showed a melanocytic proliferation exhibiting a predominantly nested growth pattern, with the nests mostly located at the dermoepithelial junction and with retraction artifact surrounding the nests. There were variable nuclear hyperchromatism, nuclear sizes, and cytologic atypia within the NMN biopsy specimens,” the researchers said. “In contrast, the histology of SUM demonstrates a predominance of atypical single melanocytes over nests, retraction artifacts around individual melanocytes, and uniform atypia of melanocytes throughout the biopsy specimen.”

SOURCE: Lee JH et al. J Am Acad Dermatol. 2018 Mar;78(3):479-89.

When longitudinal melanonychia appears as a sharply demarcated pigment band of even width against normal nail in a child, Hutchinson’s sign with longitudinal brushy pigmentation may be a useful clinical pattern suggesting a diagnosis of nail matrix nevus rather than subungual melanoma, said Jae Ho Lee, MD, of Sungkyunkwan University, Seoul, South Korea, and associates.

In a study of biopsy-proven nail matrix nevi (NMN) in 20 children and 8 adults, average melanonychia width was 3.5 times greater in children than in adults, with 14 children having melanonychia greater than 20% the width of the nail, compared with 2 adults. Total melanonychia occurred just twice, in two children. A total of 12 children had nail dystrophy, while none of the adults did; nail dystrophy was more frequent in wider lesions.

Hutchinson’s sign was seen in seven pediatric patients, but no adult patients. In most cases, Hutchinson’s sign had hyponychial pigmentation, and on dermoscopy showed a pigment pattern presenting longitudinally and resembling a brush mark (longitudinal brushy pigmentation or LBP). LBP of nail matrix nevi is different from the Hutchinson’s sign that occurs in subungual melanoma (SUM), where it is typically a “haphazard pigmentation pattern involving periungual skin.

“We propose that Hutchinson’s sign occurs more commonly in pediatric NMN than in adult NMN, and that the presence of the LBP pattern can help distinguish pediatric NMN from SUM,” the investigators said.

Histologically, the biopsies of the NMN in this study showed some important differences from known SUM histology. All the study biopsies “showed a melanocytic proliferation exhibiting a predominantly nested growth pattern, with the nests mostly located at the dermoepithelial junction and with retraction artifact surrounding the nests. There were variable nuclear hyperchromatism, nuclear sizes, and cytologic atypia within the NMN biopsy specimens,” the researchers said. “In contrast, the histology of SUM demonstrates a predominance of atypical single melanocytes over nests, retraction artifacts around individual melanocytes, and uniform atypia of melanocytes throughout the biopsy specimen.”

SOURCE: Lee JH et al. J Am Acad Dermatol. 2018 Mar;78(3):479-89.

When longitudinal melanonychia appears as a sharply demarcated pigment band of even width against normal nail in a child, Hutchinson’s sign with longitudinal brushy pigmentation may be a useful clinical pattern suggesting a diagnosis of nail matrix nevus rather than subungual melanoma, said Jae Ho Lee, MD, of Sungkyunkwan University, Seoul, South Korea, and associates.

In a study of biopsy-proven nail matrix nevi (NMN) in 20 children and 8 adults, average melanonychia width was 3.5 times greater in children than in adults, with 14 children having melanonychia greater than 20% the width of the nail, compared with 2 adults. Total melanonychia occurred just twice, in two children. A total of 12 children had nail dystrophy, while none of the adults did; nail dystrophy was more frequent in wider lesions.

Hutchinson’s sign was seen in seven pediatric patients, but no adult patients. In most cases, Hutchinson’s sign had hyponychial pigmentation, and on dermoscopy showed a pigment pattern presenting longitudinally and resembling a brush mark (longitudinal brushy pigmentation or LBP). LBP of nail matrix nevi is different from the Hutchinson’s sign that occurs in subungual melanoma (SUM), where it is typically a “haphazard pigmentation pattern involving periungual skin.

“We propose that Hutchinson’s sign occurs more commonly in pediatric NMN than in adult NMN, and that the presence of the LBP pattern can help distinguish pediatric NMN from SUM,” the investigators said.

Histologically, the biopsies of the NMN in this study showed some important differences from known SUM histology. All the study biopsies “showed a melanocytic proliferation exhibiting a predominantly nested growth pattern, with the nests mostly located at the dermoepithelial junction and with retraction artifact surrounding the nests. There were variable nuclear hyperchromatism, nuclear sizes, and cytologic atypia within the NMN biopsy specimens,” the researchers said. “In contrast, the histology of SUM demonstrates a predominance of atypical single melanocytes over nests, retraction artifacts around individual melanocytes, and uniform atypia of melanocytes throughout the biopsy specimen.”

SOURCE: Lee JH et al. J Am Acad Dermatol. 2018 Mar;78(3):479-89.

Psoriasis patients showed a greater prevalence of childhood trauma and less resilience than persons without psoriasis, reported Maria Luigia Crosta, of Catholic University of the Sacred Heart, Rome, and her associates.

Other studies have shown that among dermatologic disorders, psoriasis has the highest link to psychiatric illness such as mood, anxiety, and personality disorders, and that patients with psoriasis have an increased risk of suicidal ideation, the investigators said.

©Rodd100/thinkstockphotos.com

SOURCE: Crosta ML et al. J Psychosom Res. 2018;106:25-8.

Psoriasis patients showed a greater prevalence of childhood trauma and less resilience than persons without psoriasis, reported Maria Luigia Crosta, of Catholic University of the Sacred Heart, Rome, and her associates.

Other studies have shown that among dermatologic disorders, psoriasis has the highest link to psychiatric illness such as mood, anxiety, and personality disorders, and that patients with psoriasis have an increased risk of suicidal ideation, the investigators said.

©Rodd100/thinkstockphotos.com

SOURCE: Crosta ML et al. J Psychosom Res. 2018;106:25-8.

Psoriasis patients showed a greater prevalence of childhood trauma and less resilience than persons without psoriasis, reported Maria Luigia Crosta, of Catholic University of the Sacred Heart, Rome, and her associates.

Other studies have shown that among dermatologic disorders, psoriasis has the highest link to psychiatric illness such as mood, anxiety, and personality disorders, and that patients with psoriasis have an increased risk of suicidal ideation, the investigators said.

©Rodd100/thinkstockphotos.com

SOURCE: Crosta ML et al. J Psychosom Res. 2018;106:25-8.

BOSTON – Efavirenz-based antiretroviral therapy may significantly impair the effectiveness of vaginal ring contraceptives, investigators reported.

Over a 21-day period, levels of estrogen among women who used a vaginal ring (NuvaRing) while on efavirenz-based antiretroviral therapy (ART) were up to 79% lower, and levels of progestin were up to 57% lower, than in women with HIV infection who used the vaginal ring before starting ART, reported Kimberly K. Scarsi, PharmD, of the University of Nebraska, Omaha.

In contrast, women on an atazanavir-based ART regimen had lower estrogen levels than untreated controls who used a vaginal ring, but higher levels of progestin – the primary antiovulatory component of the ring – suggesting that it would retain contraceptive effectiveness, she said at the annual Conference on Retroviruses and Opportunistic Infections.

“In a broader context, these data can be applied to other drugs that behave similarly. So for example, erythromycins are also known to interfere with hormones in this way, as well as some anticonvulsant agents that may also impair the effectiveness of vaginal ring contraceptives,” she said at a brief, following her presentation of the data in an oral abstract session.

The geometric mean ratios for the efavirenz group at 7, 14, and 21 days versus controls were 0.21, 0.22, and 0.24 (P less than .05 for all comparisons). In the atazanavir group, the respective geometric mean ratios were 1.71, 1.79, and 1.74 (P less than .05 for all comparisons).

SOURCE: Scarsi KK et al. CROI 2018, Abstract 141.

BOSTON – Efavirenz-based antiretroviral therapy may significantly impair the effectiveness of vaginal ring contraceptives, investigators reported.

Over a 21-day period, levels of estrogen among women who used a vaginal ring (NuvaRing) while on efavirenz-based antiretroviral therapy (ART) were up to 79% lower, and levels of progestin were up to 57% lower, than in women with HIV infection who used the vaginal ring before starting ART, reported Kimberly K. Scarsi, PharmD, of the University of Nebraska, Omaha.

In contrast, women on an atazanavir-based ART regimen had lower estrogen levels than untreated controls who used a vaginal ring, but higher levels of progestin – the primary antiovulatory component of the ring – suggesting that it would retain contraceptive effectiveness, she said at the annual Conference on Retroviruses and Opportunistic Infections.

“In a broader context, these data can be applied to other drugs that behave similarly. So for example, erythromycins are also known to interfere with hormones in this way, as well as some anticonvulsant agents that may also impair the effectiveness of vaginal ring contraceptives,” she said at a brief, following her presentation of the data in an oral abstract session.

The geometric mean ratios for the efavirenz group at 7, 14, and 21 days versus controls were 0.21, 0.22, and 0.24 (P less than .05 for all comparisons). In the atazanavir group, the respective geometric mean ratios were 1.71, 1.79, and 1.74 (P less than .05 for all comparisons).

SOURCE: Scarsi KK et al. CROI 2018, Abstract 141.

BOSTON – Efavirenz-based antiretroviral therapy may significantly impair the effectiveness of vaginal ring contraceptives, investigators reported.

Over a 21-day period, levels of estrogen among women who used a vaginal ring (NuvaRing) while on efavirenz-based antiretroviral therapy (ART) were up to 79% lower, and levels of progestin were up to 57% lower, than in women with HIV infection who used the vaginal ring before starting ART, reported Kimberly K. Scarsi, PharmD, of the University of Nebraska, Omaha.

In contrast, women on an atazanavir-based ART regimen had lower estrogen levels than untreated controls who used a vaginal ring, but higher levels of progestin – the primary antiovulatory component of the ring – suggesting that it would retain contraceptive effectiveness, she said at the annual Conference on Retroviruses and Opportunistic Infections.

“In a broader context, these data can be applied to other drugs that behave similarly. So for example, erythromycins are also known to interfere with hormones in this way, as well as some anticonvulsant agents that may also impair the effectiveness of vaginal ring contraceptives,” she said at a brief, following her presentation of the data in an oral abstract session.

The geometric mean ratios for the efavirenz group at 7, 14, and 21 days versus controls were 0.21, 0.22, and 0.24 (P less than .05 for all comparisons). In the atazanavir group, the respective geometric mean ratios were 1.71, 1.79, and 1.74 (P less than .05 for all comparisons).

SOURCE: Scarsi KK et al. CROI 2018, Abstract 141.

Respiratory syncytial virus immunoprophylaxis in premature infants does not appear to prevent asthma at age 6 years, reported Nienke M. Scheltema, MD, of Wilhelmina Children’s Hospital, Utrecht, the Netherlands, and associates.

In a study of 395 otherwise healthy premature infants who were randomized to receive palivizumab for respiratory syncytial virus (RSV) immunoprophylaxis or placebo and followed for 6 years, 14% of the 199 infants in the RSV prevention group had parent-reported asthma, compared with 24% of the 196 in the placebo group (absolute risk reduction, 9.9%). This was explained mostly by differences in infrequent wheeze, the researchers said. However, physician-diagnosed asthma in the past 12 months was not significantly different between the two groups at 6 years: 10.3% in the RSV prevention group and 9.9% in the placebo group.

©Dr. Craig Lyerla/CDC

SOURCE: Scheltema NM et al. Lancet. 2018 Feb 27. doi: 10.1016/S2213-2600(18)30055-9.

Respiratory syncytial virus immunoprophylaxis in premature infants does not appear to prevent asthma at age 6 years, reported Nienke M. Scheltema, MD, of Wilhelmina Children’s Hospital, Utrecht, the Netherlands, and associates.

In a study of 395 otherwise healthy premature infants who were randomized to receive palivizumab for respiratory syncytial virus (RSV) immunoprophylaxis or placebo and followed for 6 years, 14% of the 199 infants in the RSV prevention group had parent-reported asthma, compared with 24% of the 196 in the placebo group (absolute risk reduction, 9.9%). This was explained mostly by differences in infrequent wheeze, the researchers said. However, physician-diagnosed asthma in the past 12 months was not significantly different between the two groups at 6 years: 10.3% in the RSV prevention group and 9.9% in the placebo group.

©Dr. Craig Lyerla/CDC

SOURCE: Scheltema NM et al. Lancet. 2018 Feb 27. doi: 10.1016/S2213-2600(18)30055-9.

Respiratory syncytial virus immunoprophylaxis in premature infants does not appear to prevent asthma at age 6 years, reported Nienke M. Scheltema, MD, of Wilhelmina Children’s Hospital, Utrecht, the Netherlands, and associates.

In a study of 395 otherwise healthy premature infants who were randomized to receive palivizumab for respiratory syncytial virus (RSV) immunoprophylaxis or placebo and followed for 6 years, 14% of the 199 infants in the RSV prevention group had parent-reported asthma, compared with 24% of the 196 in the placebo group (absolute risk reduction, 9.9%). This was explained mostly by differences in infrequent wheeze, the researchers said. However, physician-diagnosed asthma in the past 12 months was not significantly different between the two groups at 6 years: 10.3% in the RSV prevention group and 9.9% in the placebo group.

©Dr. Craig Lyerla/CDC

SOURCE: Scheltema NM et al. Lancet. 2018 Feb 27. doi: 10.1016/S2213-2600(18)30055-9.

Dr. Geppert. I have the pleasure of interviewing Dr. Larry Davis, Distinguished Professor of Neurology at the University of New Mexico School of Medicine in Albuquerque and chief of the NMVAHCS Neurology Service. Welcome, Dr. Davis. Can you describe a teleneurology visit?

Dr. Davis. The NMVAHCS is the only VA located in a large rural state. Location is a real challenge because we treat a lot of veterans who live rurally, and they often have to travel 5 to 6 hours to Albuquerque. When the VA set up its telehealth systems, it was obvious to the NMVAHCS Neurology Service that this was a gold mine. We have many patients who are unable to drive because of their neurologic condition, and they need a caregiver—sometimes a spouse—to drive them to NMVAHCS to see a neurologist, usually in an outpatient setting, often for 30 to 45 minutes, and then drive back 5 hours.

When I get a consult from a rural CBOC, I invite the patient to come to NMVAHCS for the first visit. First, I examine the patient face-to-face so the patient can get to know me. Second, I order special tests or imaging, which are not available in rural areas. Sometimes, for complicated cases, the patient stays overnight.

We discuss the diagnosis with the patient, and make the decision whether the patient is a good candidate for telehealth. If the patient consents and wants to be seen at a local community VA center, we set it up. On a given day, the patient travels—often 15, 20 minutes at most—to the VA facility and goes into a modified examination room. The patient sits in front of a TV screen with a camera focused on him or her. The patient can see me on the screen. In my office I have 2 screens, one has the patient record; the other allows me to see the patient.

Over the years, I have discovered that once I know the patient, it’s just like talking across the table. I can get a history of what has changed either with medications or chronic illness since the last follow-up.

Dr. Geppert. What are the issues and challenges in treating patients with epilepsy, multiple sclerosis, and other neurologic conditions?

Dr. Davis. We have the most difficultly with sensory examinations. I can perform a good motor examination via telehealth, but it is more difficult if I need to look carefully at the patient’s reflexes. We follow individuals with headaches, seizures, multiple sclerosis, Parkinson disease, and a variety of other illnesses. There are not too many we cannot follow that way. If patients have questions, I can look at their medical record and laboratory data while they are on the screen.

The caregiver or spouse can sit next to the patient, so they can be part of the conversation. If the patient is having trouble describing what is going on, the caregiver can offer comments.

Dr. Geppert. If I’m the patient and I’ve had a previous stroke and it looks as though I might have had another, wouldn’t you like to do a neurologic exam but can’t via telehealth?

Dr. Davis. That’s a very good point. When I talk to a patient and I don’t like what I see, I have the ability to ask the patient to come to NMVAHCS. I had one patient who suddenly started getting chest pains during the exam, so we called the CBOC primary care doctor to immediately move the patient to the local hospital. I had another patient who started talking about suicide. I kept the patient on the phone, but we got the primary care doctor in the room. We do have backup.

Dr. Geppert. You mentioned that you often involve family and that you work with local CBOC registered nurses (RNs). Can you tell us how you extend the reach of teleneurology through self-care and family education?

Dr. Davis. We have 2 qualified RN patient educators. One is an expert in Parkinson disease; the other follows up with the patient who has had a stroke, to reduce risk factors for a second stroke.

When I see a patient for a limited time, I deal with the drugs and things like that. I am less focused on what type of chair the patient should sit on, whether the patient might fall, how to safely get up, etc. So I set up a separate appointment with the nurse educator, who goes through all the day-to-day activities that the patient has to be able to do. Patients with Parkinson disease do not like to sit on low sofas, for example. What are the tricks for constipation? If a patient falls, how do you safely get up? The nurse will have the patient get down right in front of the camera and walk them through how to get up.

Dr. Geppert. I know that in many rural areas, especially in our state, there are real shortages of neurologists and psychiatrists. Can you talk about how this helps multiply your ability to care for patients?

Dr. Davis. With the exception of 3 different communities, there are no neurologists within 50 to 100 miles.

Dr. Geppert. Or neuropsychiatrists.

Dr. Davis. Or neuropsychiatrists or even a psychiatry office. So patients are very limited. We have an extremely loyal population of VA patients because it isn’t easy to say, “I’m just going to go down the street and get another doc.”

Dr. Geppert. What type of feedback do you get from patients and family about doing this virtually?

Dr. Davis. We sent a carefully worded satisfaction survey and received 700 responses. We found the following responses: 90% agreed that they received good care during their visit. Ninety-one percent reported that they were able to communicate and 87% would continue their care via teleneurology. Was the teleneurology more convenient than driving here? Yes, 90% said that it was. And did they have overall satisfaction with the visit? Literally 90% reported that they did. It’s a very high satisfaction rate.

We know that patients will say, “Oh, you can see me every 3 months, but I want to come down to see you face-to-face from time-to-time.” When I ask why, the most common answers are either “I live so rurally, there are no stores.” Or “I have family, and I want to come down.” So we then try to set up that face-to-face visit on a Friday.

If they’re traveling, they get their travel pay, but then they get to spend the weekend with a friend or family. There are often secondary reasons. Occasionally, they have to come back for another specialist; we make great efforts to put both those visits on the same day so they don’t have to go back and forth.

Dr. Geppert. So Dr. Davis, you’re a world-famous neurologist, but do you have to have special training or expertise to do teleneurology?

Dr. Davis. It helps to be a good clinician; I’ve been doing this for many years. Because we see patients on a sequence by television, I have to keep track of the time, whereas in the face-to-face clinic if something is really going wrong, I have the ability to shift things around right away and spend more time with that patient. I try to set up longer times for telehealth. I work with a clinical nurse practitioner colleague who takes care of headache patients, and she has a shorter time between visits. I never quite know what’s going to happen, and I want to leave a lot of time for the patient or the spouse to ask questions.

Dr. Geppert. We are both, certainly, senior clinicians and technology is a little different and new. Did you have problems learning to use the teleneurology?

Dr. Davis. Believe it or not, no. The television system is very similar to Skype. It is called Jabber and is encrypted, so it’s safe to transmit. You have to feel comfortable talking to somebody on a TV screen. And the first time I did it, I felt a little awkward. Within a day or two, I was fine.

Dr. Geppert. Federal Practitioner readers may want to start teleneurology or get more involved in it. Are you in touch with other VA and DoD providers?

Dr. Davis. Practitioners can contact me if they want to talk about how we do patient education. We’ve also spent a fair amount of effort developing a handbook that we send out on the ABCs of how to do it.

Dr. Geppert. Do you involve residents in this?

Dr. Davis. No, not at this point. My goal is to do it, but ironically enough, I’m trying to get students who rotate out here to get a feel for what telehealth could be. They don’t do the exam and everything else, but they get a chance to see what telehealth can be. If they want to live in a rural state, they may be involved in it.

Dr. Geppert. If the primary care provider was seeing a patient with multiple sclerosis, which we both know can have symptom flare ups, would they be able to contact you and say, “Hey, Dr. Davis, I’m seeing so and so, and she looks like she’s having some visual problems today.”

Dr. Davis. That’s harder to do because we’re not the only ones using the telehealth system. Telemental health, dietitians, and others are using it all the time, so I have to have a scheduled time to be able to see patients. I’m surprised that more rural states aren’t using it because it really is very enjoyable.

Dr. Geppert. What has the VA learned about telehealth from this program?

Dr. Davis. We know that it actually saves NMVAHCS a lot of money because we don’t pay as much travel pay. The patients like it. The CBOC physicians like it because if I have to, I can type the note right away, and they can read it if the patient is staying there.

Author disclosures
Dr. Hixson has received a collaborative grant from UCB Inc. for research on online epilepsy resources.

Disclaimer
The opinions expressed herein do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Dr. Geppert. I have the pleasure of interviewing Dr. Larry Davis, Distinguished Professor of Neurology at the University of New Mexico School of Medicine in Albuquerque and chief of the NMVAHCS Neurology Service. Welcome, Dr. Davis. Can you describe a teleneurology visit?

Dr. Davis. The NMVAHCS is the only VA located in a large rural state. Location is a real challenge because we treat a lot of veterans who live rurally, and they often have to travel 5 to 6 hours to Albuquerque. When the VA set up its telehealth systems, it was obvious to the NMVAHCS Neurology Service that this was a gold mine. We have many patients who are unable to drive because of their neurologic condition, and they need a caregiver—sometimes a spouse—to drive them to NMVAHCS to see a neurologist, usually in an outpatient setting, often for 30 to 45 minutes, and then drive back 5 hours.

When I get a consult from a rural CBOC, I invite the patient to come to NMVAHCS for the first visit. First, I examine the patient face-to-face so the patient can get to know me. Second, I order special tests or imaging, which are not available in rural areas. Sometimes, for complicated cases, the patient stays overnight.

We discuss the diagnosis with the patient, and make the decision whether the patient is a good candidate for telehealth. If the patient consents and wants to be seen at a local community VA center, we set it up. On a given day, the patient travels—often 15, 20 minutes at most—to the VA facility and goes into a modified examination room. The patient sits in front of a TV screen with a camera focused on him or her. The patient can see me on the screen. In my office I have 2 screens, one has the patient record; the other allows me to see the patient.

Over the years, I have discovered that once I know the patient, it’s just like talking across the table. I can get a history of what has changed either with medications or chronic illness since the last follow-up.

Dr. Geppert. What are the issues and challenges in treating patients with epilepsy, multiple sclerosis, and other neurologic conditions?

Dr. Davis. We have the most difficultly with sensory examinations. I can perform a good motor examination via telehealth, but it is more difficult if I need to look carefully at the patient’s reflexes. We follow individuals with headaches, seizures, multiple sclerosis, Parkinson disease, and a variety of other illnesses. There are not too many we cannot follow that way. If patients have questions, I can look at their medical record and laboratory data while they are on the screen.

The caregiver or spouse can sit next to the patient, so they can be part of the conversation. If the patient is having trouble describing what is going on, the caregiver can offer comments.

Dr. Geppert. If I’m the patient and I’ve had a previous stroke and it looks as though I might have had another, wouldn’t you like to do a neurologic exam but can’t via telehealth?

Dr. Davis. That’s a very good point. When I talk to a patient and I don’t like what I see, I have the ability to ask the patient to come to NMVAHCS. I had one patient who suddenly started getting chest pains during the exam, so we called the CBOC primary care doctor to immediately move the patient to the local hospital. I had another patient who started talking about suicide. I kept the patient on the phone, but we got the primary care doctor in the room. We do have backup.

Dr. Geppert. You mentioned that you often involve family and that you work with local CBOC registered nurses (RNs). Can you tell us how you extend the reach of teleneurology through self-care and family education?

Dr. Davis. We have 2 qualified RN patient educators. One is an expert in Parkinson disease; the other follows up with the patient who has had a stroke, to reduce risk factors for a second stroke.

When I see a patient for a limited time, I deal with the drugs and things like that. I am less focused on what type of chair the patient should sit on, whether the patient might fall, how to safely get up, etc. So I set up a separate appointment with the nurse educator, who goes through all the day-to-day activities that the patient has to be able to do. Patients with Parkinson disease do not like to sit on low sofas, for example. What are the tricks for constipation? If a patient falls, how do you safely get up? The nurse will have the patient get down right in front of the camera and walk them through how to get up.

Dr. Geppert. I know that in many rural areas, especially in our state, there are real shortages of neurologists and psychiatrists. Can you talk about how this helps multiply your ability to care for patients?

Dr. Davis. With the exception of 3 different communities, there are no neurologists within 50 to 100 miles.

Dr. Geppert. Or neuropsychiatrists.

Dr. Davis. Or neuropsychiatrists or even a psychiatry office. So patients are very limited. We have an extremely loyal population of VA patients because it isn’t easy to say, “I’m just going to go down the street and get another doc.”

Dr. Geppert. What type of feedback do you get from patients and family about doing this virtually?

Dr. Davis. We sent a carefully worded satisfaction survey and received 700 responses. We found the following responses: 90% agreed that they received good care during their visit. Ninety-one percent reported that they were able to communicate and 87% would continue their care via teleneurology. Was the teleneurology more convenient than driving here? Yes, 90% said that it was. And did they have overall satisfaction with the visit? Literally 90% reported that they did. It’s a very high satisfaction rate.

We know that patients will say, “Oh, you can see me every 3 months, but I want to come down to see you face-to-face from time-to-time.” When I ask why, the most common answers are either “I live so rurally, there are no stores.” Or “I have family, and I want to come down.” So we then try to set up that face-to-face visit on a Friday.

If they’re traveling, they get their travel pay, but then they get to spend the weekend with a friend or family. There are often secondary reasons. Occasionally, they have to come back for another specialist; we make great efforts to put both those visits on the same day so they don’t have to go back and forth.

Dr. Geppert. So Dr. Davis, you’re a world-famous neurologist, but do you have to have special training or expertise to do teleneurology?

Dr. Davis. It helps to be a good clinician; I’ve been doing this for many years. Because we see patients on a sequence by television, I have to keep track of the time, whereas in the face-to-face clinic if something is really going wrong, I have the ability to shift things around right away and spend more time with that patient. I try to set up longer times for telehealth. I work with a clinical nurse practitioner colleague who takes care of headache patients, and she has a shorter time between visits. I never quite know what’s going to happen, and I want to leave a lot of time for the patient or the spouse to ask questions.

Dr. Geppert. We are both, certainly, senior clinicians and technology is a little different and new. Did you have problems learning to use the teleneurology?

Dr. Davis. Believe it or not, no. The television system is very similar to Skype. It is called Jabber and is encrypted, so it’s safe to transmit. You have to feel comfortable talking to somebody on a TV screen. And the first time I did it, I felt a little awkward. Within a day or two, I was fine.

Dr. Geppert. Federal Practitioner readers may want to start teleneurology or get more involved in it. Are you in touch with other VA and DoD providers?

Dr. Davis. Practitioners can contact me if they want to talk about how we do patient education. We’ve also spent a fair amount of effort developing a handbook that we send out on the ABCs of how to do it.

Dr. Geppert. Do you involve residents in this?

Dr. Davis. No, not at this point. My goal is to do it, but ironically enough, I’m trying to get students who rotate out here to get a feel for what telehealth could be. They don’t do the exam and everything else, but they get a chance to see what telehealth can be. If they want to live in a rural state, they may be involved in it.

Dr. Geppert. If the primary care provider was seeing a patient with multiple sclerosis, which we both know can have symptom flare ups, would they be able to contact you and say, “Hey, Dr. Davis, I’m seeing so and so, and she looks like she’s having some visual problems today.”

Dr. Davis. That’s harder to do because we’re not the only ones using the telehealth system. Telemental health, dietitians, and others are using it all the time, so I have to have a scheduled time to be able to see patients. I’m surprised that more rural states aren’t using it because it really is very enjoyable.

Dr. Geppert. What has the VA learned about telehealth from this program?

Dr. Davis. We know that it actually saves NMVAHCS a lot of money because we don’t pay as much travel pay. The patients like it. The CBOC physicians like it because if I have to, I can type the note right away, and they can read it if the patient is staying there.

Author disclosures
Dr. Hixson has received a collaborative grant from UCB Inc. for research on online epilepsy resources.

Disclaimer
The opinions expressed herein do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Dr. Geppert. I have the pleasure of interviewing Dr. Larry Davis, Distinguished Professor of Neurology at the University of New Mexico School of Medicine in Albuquerque and chief of the NMVAHCS Neurology Service. Welcome, Dr. Davis. Can you describe a teleneurology visit?

Dr. Davis. The NMVAHCS is the only VA located in a large rural state. Location is a real challenge because we treat a lot of veterans who live rurally, and they often have to travel 5 to 6 hours to Albuquerque. When the VA set up its telehealth systems, it was obvious to the NMVAHCS Neurology Service that this was a gold mine. We have many patients who are unable to drive because of their neurologic condition, and they need a caregiver—sometimes a spouse—to drive them to NMVAHCS to see a neurologist, usually in an outpatient setting, often for 30 to 45 minutes, and then drive back 5 hours.

When I get a consult from a rural CBOC, I invite the patient to come to NMVAHCS for the first visit. First, I examine the patient face-to-face so the patient can get to know me. Second, I order special tests or imaging, which are not available in rural areas. Sometimes, for complicated cases, the patient stays overnight.

We discuss the diagnosis with the patient, and make the decision whether the patient is a good candidate for telehealth. If the patient consents and wants to be seen at a local community VA center, we set it up. On a given day, the patient travels—often 15, 20 minutes at most—to the VA facility and goes into a modified examination room. The patient sits in front of a TV screen with a camera focused on him or her. The patient can see me on the screen. In my office I have 2 screens, one has the patient record; the other allows me to see the patient.

Over the years, I have discovered that once I know the patient, it’s just like talking across the table. I can get a history of what has changed either with medications or chronic illness since the last follow-up.

Dr. Geppert. What are the issues and challenges in treating patients with epilepsy, multiple sclerosis, and other neurologic conditions?

Dr. Davis. We have the most difficultly with sensory examinations. I can perform a good motor examination via telehealth, but it is more difficult if I need to look carefully at the patient’s reflexes. We follow individuals with headaches, seizures, multiple sclerosis, Parkinson disease, and a variety of other illnesses. There are not too many we cannot follow that way. If patients have questions, I can look at their medical record and laboratory data while they are on the screen.

The caregiver or spouse can sit next to the patient, so they can be part of the conversation. If the patient is having trouble describing what is going on, the caregiver can offer comments.

Dr. Geppert. If I’m the patient and I’ve had a previous stroke and it looks as though I might have had another, wouldn’t you like to do a neurologic exam but can’t via telehealth?

Dr. Davis. That’s a very good point. When I talk to a patient and I don’t like what I see, I have the ability to ask the patient to come to NMVAHCS. I had one patient who suddenly started getting chest pains during the exam, so we called the CBOC primary care doctor to immediately move the patient to the local hospital. I had another patient who started talking about suicide. I kept the patient on the phone, but we got the primary care doctor in the room. We do have backup.

Dr. Geppert. You mentioned that you often involve family and that you work with local CBOC registered nurses (RNs). Can you tell us how you extend the reach of teleneurology through self-care and family education?

Dr. Davis. We have 2 qualified RN patient educators. One is an expert in Parkinson disease; the other follows up with the patient who has had a stroke, to reduce risk factors for a second stroke.

When I see a patient for a limited time, I deal with the drugs and things like that. I am less focused on what type of chair the patient should sit on, whether the patient might fall, how to safely get up, etc. So I set up a separate appointment with the nurse educator, who goes through all the day-to-day activities that the patient has to be able to do. Patients with Parkinson disease do not like to sit on low sofas, for example. What are the tricks for constipation? If a patient falls, how do you safely get up? The nurse will have the patient get down right in front of the camera and walk them through how to get up.

Dr. Geppert. I know that in many rural areas, especially in our state, there are real shortages of neurologists and psychiatrists. Can you talk about how this helps multiply your ability to care for patients?

Dr. Davis. With the exception of 3 different communities, there are no neurologists within 50 to 100 miles.

Dr. Geppert. Or neuropsychiatrists.

Dr. Davis. Or neuropsychiatrists or even a psychiatry office. So patients are very limited. We have an extremely loyal population of VA patients because it isn’t easy to say, “I’m just going to go down the street and get another doc.”

Dr. Geppert. What type of feedback do you get from patients and family about doing this virtually?

Dr. Davis. We sent a carefully worded satisfaction survey and received 700 responses. We found the following responses: 90% agreed that they received good care during their visit. Ninety-one percent reported that they were able to communicate and 87% would continue their care via teleneurology. Was the teleneurology more convenient than driving here? Yes, 90% said that it was. And did they have overall satisfaction with the visit? Literally 90% reported that they did. It’s a very high satisfaction rate.

We know that patients will say, “Oh, you can see me every 3 months, but I want to come down to see you face-to-face from time-to-time.” When I ask why, the most common answers are either “I live so rurally, there are no stores.” Or “I have family, and I want to come down.” So we then try to set up that face-to-face visit on a Friday.

If they’re traveling, they get their travel pay, but then they get to spend the weekend with a friend or family. There are often secondary reasons. Occasionally, they have to come back for another specialist; we make great efforts to put both those visits on the same day so they don’t have to go back and forth.

Dr. Geppert. So Dr. Davis, you’re a world-famous neurologist, but do you have to have special training or expertise to do teleneurology?

Dr. Davis. It helps to be a good clinician; I’ve been doing this for many years. Because we see patients on a sequence by television, I have to keep track of the time, whereas in the face-to-face clinic if something is really going wrong, I have the ability to shift things around right away and spend more time with that patient. I try to set up longer times for telehealth. I work with a clinical nurse practitioner colleague who takes care of headache patients, and she has a shorter time between visits. I never quite know what’s going to happen, and I want to leave a lot of time for the patient or the spouse to ask questions.

Dr. Geppert. We are both, certainly, senior clinicians and technology is a little different and new. Did you have problems learning to use the teleneurology?

Dr. Davis. Believe it or not, no. The television system is very similar to Skype. It is called Jabber and is encrypted, so it’s safe to transmit. You have to feel comfortable talking to somebody on a TV screen. And the first time I did it, I felt a little awkward. Within a day or two, I was fine.

Dr. Geppert. Federal Practitioner readers may want to start teleneurology or get more involved in it. Are you in touch with other VA and DoD providers?

Dr. Davis. Practitioners can contact me if they want to talk about how we do patient education. We’ve also spent a fair amount of effort developing a handbook that we send out on the ABCs of how to do it.

Dr. Geppert. Do you involve residents in this?

Dr. Davis. No, not at this point. My goal is to do it, but ironically enough, I’m trying to get students who rotate out here to get a feel for what telehealth could be. They don’t do the exam and everything else, but they get a chance to see what telehealth can be. If they want to live in a rural state, they may be involved in it.

Dr. Geppert. If the primary care provider was seeing a patient with multiple sclerosis, which we both know can have symptom flare ups, would they be able to contact you and say, “Hey, Dr. Davis, I’m seeing so and so, and she looks like she’s having some visual problems today.”

Dr. Davis. That’s harder to do because we’re not the only ones using the telehealth system. Telemental health, dietitians, and others are using it all the time, so I have to have a scheduled time to be able to see patients. I’m surprised that more rural states aren’t using it because it really is very enjoyable.

Dr. Geppert. What has the VA learned about telehealth from this program?

Dr. Davis. We know that it actually saves NMVAHCS a lot of money because we don’t pay as much travel pay. The patients like it. The CBOC physicians like it because if I have to, I can type the note right away, and they can read it if the patient is staying there.

Author disclosures
Dr. Hixson has received a collaborative grant from UCB Inc. for research on online epilepsy resources.

Disclaimer
The opinions expressed herein do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Red blood cells

Amgen has withdrawn its application to expand the existing marketing authorization for darbepoetin alfa (Aranesp), according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The goal with this application was to extend the authorization for darbepoetin alfa to include the treatment of anemia in adults with low-risk or intermediate-1-risk myelodysplastic syndromes (MDS) who have low transfusion demand.

Darbepoetin alfa is currently approved in the European Union (EU) to treat anemia in adults and children with chronic renal failure and adults who are receiving chemotherapy for non-myeloid malignancies.

Amgen withdrew the application for darbepoetin alfa in MDS patients after the CHMP had evaluated initial documentation provided by the company and formulated a list of questions. Amgen had not yet responded to the questions when it notified the CHMP of the withdrawal.

At the time of the withdrawal, the CHMP was of the provisional opinion that darbepoetin alfa could not have been approved for the treatment of anemia in adults with MDS.

This opinion was based on concerns about the data supporting the application—results from the phase 3 ARCADE trial (NCT01362140) and a phase 2 trial (NCT00095264).

The CHMP said changes to the design of the phase 3 trial and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.

In addition, the phase 2 trial, which was conducted in the US, was not in line with EU recommendations for the treatment of MDS patients.

Therefore, at the time of the withdrawal, the CHMP had decided the marketing authorization could not be expanded based on the data provided.

In a letter to the CHMP, Amgen said its decision to withdraw the application is based on the CHMP’s negative opinion.

Red blood cells

Amgen has withdrawn its application to expand the existing marketing authorization for darbepoetin alfa (Aranesp), according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The goal with this application was to extend the authorization for darbepoetin alfa to include the treatment of anemia in adults with low-risk or intermediate-1-risk myelodysplastic syndromes (MDS) who have low transfusion demand.

Darbepoetin alfa is currently approved in the European Union (EU) to treat anemia in adults and children with chronic renal failure and adults who are receiving chemotherapy for non-myeloid malignancies.

Amgen withdrew the application for darbepoetin alfa in MDS patients after the CHMP had evaluated initial documentation provided by the company and formulated a list of questions. Amgen had not yet responded to the questions when it notified the CHMP of the withdrawal.

At the time of the withdrawal, the CHMP was of the provisional opinion that darbepoetin alfa could not have been approved for the treatment of anemia in adults with MDS.

This opinion was based on concerns about the data supporting the application—results from the phase 3 ARCADE trial (NCT01362140) and a phase 2 trial (NCT00095264).

The CHMP said changes to the design of the phase 3 trial and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.

In addition, the phase 2 trial, which was conducted in the US, was not in line with EU recommendations for the treatment of MDS patients.

Therefore, at the time of the withdrawal, the CHMP had decided the marketing authorization could not be expanded based on the data provided.

In a letter to the CHMP, Amgen said its decision to withdraw the application is based on the CHMP’s negative opinion.

Red blood cells

Amgen has withdrawn its application to expand the existing marketing authorization for darbepoetin alfa (Aranesp), according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The goal with this application was to extend the authorization for darbepoetin alfa to include the treatment of anemia in adults with low-risk or intermediate-1-risk myelodysplastic syndromes (MDS) who have low transfusion demand.

Darbepoetin alfa is currently approved in the European Union (EU) to treat anemia in adults and children with chronic renal failure and adults who are receiving chemotherapy for non-myeloid malignancies.

Amgen withdrew the application for darbepoetin alfa in MDS patients after the CHMP had evaluated initial documentation provided by the company and formulated a list of questions. Amgen had not yet responded to the questions when it notified the CHMP of the withdrawal.

At the time of the withdrawal, the CHMP was of the provisional opinion that darbepoetin alfa could not have been approved for the treatment of anemia in adults with MDS.

This opinion was based on concerns about the data supporting the application—results from the phase 3 ARCADE trial (NCT01362140) and a phase 2 trial (NCT00095264).

The CHMP said changes to the design of the phase 3 trial and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.

In addition, the phase 2 trial, which was conducted in the US, was not in line with EU recommendations for the treatment of MDS patients.

Therefore, at the time of the withdrawal, the CHMP had decided the marketing authorization could not be expanded based on the data provided.

In a letter to the CHMP, Amgen said its decision to withdraw the application is based on the CHMP’s negative opinion.

BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.

Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.

“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”

After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.

“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.

Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.

“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.

BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.

Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.

“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”

After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.

“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.

Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.

“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.

BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.

Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.

“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”

After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.

“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.

Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.

“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.