Unique MRI Findings in Juvenile Myoclonic Epilepsy

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Unique MRI Findings in Juvenile Myoclonic Epilepsy
Epilepsia; ePub 2018 Oct 3; Garcia-Ramos et al.

The cortical regions of the brains of patients with juvenile myoclonic epilepsy (JME) are more likely to be disassociated from subcortical structures, according to a recent study that compared the MRI readings of JME patients to those of normal children. 

  • Investigators from the University of Wisconsin School of Medicine compared 21 children with JME to 22 healthy controls over a 2 year period.
  • Normal children had modular cortical development and network integration between cortical and subcortical regions.
  • Patients with epilepsy had a less modular cortical network that was disassociated from subcortical structures.
  • Children with JME were also found to have weaker modules or communities, as indicated by higher clustering and lower modularity indices.

 

Garcia-Ramos C, Dabbs K, Lin JJ, et al. Progressive dissociation of cortical and subcortical network development in children with newonset juvenile myoclonic epilepsy [Published online ahead of print Oct 3, 2018]. Epilepsia.  https://doi.org/10.1111/epi.14560

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Epilepsia; ePub 2018 Oct 3; Garcia-Ramos et al.
Epilepsia; ePub 2018 Oct 3; Garcia-Ramos et al.

The cortical regions of the brains of patients with juvenile myoclonic epilepsy (JME) are more likely to be disassociated from subcortical structures, according to a recent study that compared the MRI readings of JME patients to those of normal children. 

  • Investigators from the University of Wisconsin School of Medicine compared 21 children with JME to 22 healthy controls over a 2 year period.
  • Normal children had modular cortical development and network integration between cortical and subcortical regions.
  • Patients with epilepsy had a less modular cortical network that was disassociated from subcortical structures.
  • Children with JME were also found to have weaker modules or communities, as indicated by higher clustering and lower modularity indices.

 

Garcia-Ramos C, Dabbs K, Lin JJ, et al. Progressive dissociation of cortical and subcortical network development in children with newonset juvenile myoclonic epilepsy [Published online ahead of print Oct 3, 2018]. Epilepsia.  https://doi.org/10.1111/epi.14560

The cortical regions of the brains of patients with juvenile myoclonic epilepsy (JME) are more likely to be disassociated from subcortical structures, according to a recent study that compared the MRI readings of JME patients to those of normal children. 

  • Investigators from the University of Wisconsin School of Medicine compared 21 children with JME to 22 healthy controls over a 2 year period.
  • Normal children had modular cortical development and network integration between cortical and subcortical regions.
  • Patients with epilepsy had a less modular cortical network that was disassociated from subcortical structures.
  • Children with JME were also found to have weaker modules or communities, as indicated by higher clustering and lower modularity indices.

 

Garcia-Ramos C, Dabbs K, Lin JJ, et al. Progressive dissociation of cortical and subcortical network development in children with newonset juvenile myoclonic epilepsy [Published online ahead of print Oct 3, 2018]. Epilepsia.  https://doi.org/10.1111/epi.14560

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Platelet-rich patch helps heal difficult diabetic foot ulcers

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Diabetic foot ulcers that were designated as difficult to treat were 58% more likely to heal when they were treated with LeucoPatch than using the best standard care alone in a randomized, controlled study.

With the LeucoPatch – which contained study participants’ own cells (platelets, fibrin, and leukocytes) – 34.1% of ulcers healed within 20 weeks versus 21.6% of ulcers that were treated using the best standard care (unadjusted odds ratio, 1.58; 95% confidence interval, 1.06-2.25; P = .02). Healing was defined as complete epithelialization maintained for 4 weeks, as confirmed by an observer blinded to the treatment group.

Dr. Frances Game


Results remained significant after adjusting for baseline wound size (adjusted OR 1.89; P = .02) and following a per-protocol analysis (aOR, 1.75; P = .048).

Furthermore, time to healing was shorter in the intervention group (P = .02), lead study investigator Frances Game, MD, of the Derby (England) Teaching Hospitals National Health Service Foundation Trust, reported at the annual meeting of the European Association for the Study of Diabetes.

“Successive systematic reviews from the International Working Group of the Diabetic Foot have shown that there’s very poor evidence for many of the things that we do in day-to-day practice,” she said.

“Having said that, there have been some positive studies using platelets or platelet-rich plasma to improve healing of the diabetic foot,” Dr. Game noted, although results have been inconsistent. From this the idea of the LeucoPatch was born. This is an autologous active cell therapy, which according to the Danish company Reapplix that markets it, helps patients “heal themselves.”

The LeucoPatch system is made by taking 18 mL of a patient’s blood and spinning the collection tube in a centrifuge for 20 minutes to generate a three-layered disc that contains fibrin, platelets, and leukocytes. This can then be applied to the surface of the diabetic foot ulcer. Dr. Game noted that 18 mL of blood will make a 5-cm patch and more than one patch can be made from the blood sample.

“It looks like a bit of wet skin when it comes out of the centrifuge and you just put it on sole side down. It’s taking the patient’s own cells, that often aren’t getting to the ulcer because of the morbidity of the patient and vascular disease, and actually putting them where they need to be,” she explained. The patch usually becomes absorbed within a week; depending on the ulcer, reapplication may be required.

“It’s quite a straightforward procedure that’s performed the bedside,” Dr. Game observed. “That’s how we were able to recruit so many patients, as it’s quite simple.” Indeed, almost 600 people with diabetic foot ulcers agreed to participate in the study, but only those with difficult-to-treat ulcers were included after a 4-week run-in period. The 269 patients who were finally randomized were treated at 32 specialist diabetic foot clinics in the United Kingdom, Denmark, and Sweden.

The majority of participants were male (82%) and had type 2 diabetes mellitus (83%). The mean age was 62 years and the median duration of diabetes was 16 years. The mean ulcer area was 240 mm2, with 87% being superficial, 10% reaching down to the tendon, and 3% down to the bone. In 78% of cases, the total forefoot was affected, with the plantar forefoot and hind foot affected in a respective 42% and 22% of cases.

The LeucoPatch system is already being used in several European countries, including Germany and Belgium, Dr. Game noted. However, this is the first randomized, controlled trial to demonstrate a clinical and statistically significant benefit. The data show that the weekly application of LeucoPatch is clearly of benefit in a population of patients with hard-to-heal diabetic foot ulcers.

“The low drop-out numbers suggest a good patient acceptability,” she noted, and “the treatment was without apparent increase in adverse events, particularly without evidence of new onset anemia.”

Cost-effectiveness data were collected throughout the study and will be available at a future date when these have been analyzed, Dr. Game said.

The LeucoPatch system received Food and Drug Administration approval in April 2017.

The research was published online in the Lancet Diabetes & Endocrinology ahead of the presentation.

The trial was funded by Reapplix. Dr. Game reported receiving research funding from the company.

SOURCES: Game F et al. EASD 2018, Abstract 9.

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Diabetic foot ulcers that were designated as difficult to treat were 58% more likely to heal when they were treated with LeucoPatch than using the best standard care alone in a randomized, controlled study.

With the LeucoPatch – which contained study participants’ own cells (platelets, fibrin, and leukocytes) – 34.1% of ulcers healed within 20 weeks versus 21.6% of ulcers that were treated using the best standard care (unadjusted odds ratio, 1.58; 95% confidence interval, 1.06-2.25; P = .02). Healing was defined as complete epithelialization maintained for 4 weeks, as confirmed by an observer blinded to the treatment group.

Dr. Frances Game


Results remained significant after adjusting for baseline wound size (adjusted OR 1.89; P = .02) and following a per-protocol analysis (aOR, 1.75; P = .048).

Furthermore, time to healing was shorter in the intervention group (P = .02), lead study investigator Frances Game, MD, of the Derby (England) Teaching Hospitals National Health Service Foundation Trust, reported at the annual meeting of the European Association for the Study of Diabetes.

“Successive systematic reviews from the International Working Group of the Diabetic Foot have shown that there’s very poor evidence for many of the things that we do in day-to-day practice,” she said.

“Having said that, there have been some positive studies using platelets or platelet-rich plasma to improve healing of the diabetic foot,” Dr. Game noted, although results have been inconsistent. From this the idea of the LeucoPatch was born. This is an autologous active cell therapy, which according to the Danish company Reapplix that markets it, helps patients “heal themselves.”

The LeucoPatch system is made by taking 18 mL of a patient’s blood and spinning the collection tube in a centrifuge for 20 minutes to generate a three-layered disc that contains fibrin, platelets, and leukocytes. This can then be applied to the surface of the diabetic foot ulcer. Dr. Game noted that 18 mL of blood will make a 5-cm patch and more than one patch can be made from the blood sample.

“It looks like a bit of wet skin when it comes out of the centrifuge and you just put it on sole side down. It’s taking the patient’s own cells, that often aren’t getting to the ulcer because of the morbidity of the patient and vascular disease, and actually putting them where they need to be,” she explained. The patch usually becomes absorbed within a week; depending on the ulcer, reapplication may be required.

“It’s quite a straightforward procedure that’s performed the bedside,” Dr. Game observed. “That’s how we were able to recruit so many patients, as it’s quite simple.” Indeed, almost 600 people with diabetic foot ulcers agreed to participate in the study, but only those with difficult-to-treat ulcers were included after a 4-week run-in period. The 269 patients who were finally randomized were treated at 32 specialist diabetic foot clinics in the United Kingdom, Denmark, and Sweden.

The majority of participants were male (82%) and had type 2 diabetes mellitus (83%). The mean age was 62 years and the median duration of diabetes was 16 years. The mean ulcer area was 240 mm2, with 87% being superficial, 10% reaching down to the tendon, and 3% down to the bone. In 78% of cases, the total forefoot was affected, with the plantar forefoot and hind foot affected in a respective 42% and 22% of cases.

The LeucoPatch system is already being used in several European countries, including Germany and Belgium, Dr. Game noted. However, this is the first randomized, controlled trial to demonstrate a clinical and statistically significant benefit. The data show that the weekly application of LeucoPatch is clearly of benefit in a population of patients with hard-to-heal diabetic foot ulcers.

“The low drop-out numbers suggest a good patient acceptability,” she noted, and “the treatment was without apparent increase in adverse events, particularly without evidence of new onset anemia.”

Cost-effectiveness data were collected throughout the study and will be available at a future date when these have been analyzed, Dr. Game said.

The LeucoPatch system received Food and Drug Administration approval in April 2017.

The research was published online in the Lancet Diabetes & Endocrinology ahead of the presentation.

The trial was funded by Reapplix. Dr. Game reported receiving research funding from the company.

SOURCES: Game F et al. EASD 2018, Abstract 9.

 

Diabetic foot ulcers that were designated as difficult to treat were 58% more likely to heal when they were treated with LeucoPatch than using the best standard care alone in a randomized, controlled study.

With the LeucoPatch – which contained study participants’ own cells (platelets, fibrin, and leukocytes) – 34.1% of ulcers healed within 20 weeks versus 21.6% of ulcers that were treated using the best standard care (unadjusted odds ratio, 1.58; 95% confidence interval, 1.06-2.25; P = .02). Healing was defined as complete epithelialization maintained for 4 weeks, as confirmed by an observer blinded to the treatment group.

Dr. Frances Game


Results remained significant after adjusting for baseline wound size (adjusted OR 1.89; P = .02) and following a per-protocol analysis (aOR, 1.75; P = .048).

Furthermore, time to healing was shorter in the intervention group (P = .02), lead study investigator Frances Game, MD, of the Derby (England) Teaching Hospitals National Health Service Foundation Trust, reported at the annual meeting of the European Association for the Study of Diabetes.

“Successive systematic reviews from the International Working Group of the Diabetic Foot have shown that there’s very poor evidence for many of the things that we do in day-to-day practice,” she said.

“Having said that, there have been some positive studies using platelets or platelet-rich plasma to improve healing of the diabetic foot,” Dr. Game noted, although results have been inconsistent. From this the idea of the LeucoPatch was born. This is an autologous active cell therapy, which according to the Danish company Reapplix that markets it, helps patients “heal themselves.”

The LeucoPatch system is made by taking 18 mL of a patient’s blood and spinning the collection tube in a centrifuge for 20 minutes to generate a three-layered disc that contains fibrin, platelets, and leukocytes. This can then be applied to the surface of the diabetic foot ulcer. Dr. Game noted that 18 mL of blood will make a 5-cm patch and more than one patch can be made from the blood sample.

“It looks like a bit of wet skin when it comes out of the centrifuge and you just put it on sole side down. It’s taking the patient’s own cells, that often aren’t getting to the ulcer because of the morbidity of the patient and vascular disease, and actually putting them where they need to be,” she explained. The patch usually becomes absorbed within a week; depending on the ulcer, reapplication may be required.

“It’s quite a straightforward procedure that’s performed the bedside,” Dr. Game observed. “That’s how we were able to recruit so many patients, as it’s quite simple.” Indeed, almost 600 people with diabetic foot ulcers agreed to participate in the study, but only those with difficult-to-treat ulcers were included after a 4-week run-in period. The 269 patients who were finally randomized were treated at 32 specialist diabetic foot clinics in the United Kingdom, Denmark, and Sweden.

The majority of participants were male (82%) and had type 2 diabetes mellitus (83%). The mean age was 62 years and the median duration of diabetes was 16 years. The mean ulcer area was 240 mm2, with 87% being superficial, 10% reaching down to the tendon, and 3% down to the bone. In 78% of cases, the total forefoot was affected, with the plantar forefoot and hind foot affected in a respective 42% and 22% of cases.

The LeucoPatch system is already being used in several European countries, including Germany and Belgium, Dr. Game noted. However, this is the first randomized, controlled trial to demonstrate a clinical and statistically significant benefit. The data show that the weekly application of LeucoPatch is clearly of benefit in a population of patients with hard-to-heal diabetic foot ulcers.

“The low drop-out numbers suggest a good patient acceptability,” she noted, and “the treatment was without apparent increase in adverse events, particularly without evidence of new onset anemia.”

Cost-effectiveness data were collected throughout the study and will be available at a future date when these have been analyzed, Dr. Game said.

The LeucoPatch system received Food and Drug Administration approval in April 2017.

The research was published online in the Lancet Diabetes & Endocrinology ahead of the presentation.

The trial was funded by Reapplix. Dr. Game reported receiving research funding from the company.

SOURCES: Game F et al. EASD 2018, Abstract 9.

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Key clinical point: Weekly application of LeucoPatch enabled greater healing in a shorter time frame than standard care.

Major finding: Within 20 weeks, 34.1% versus 21.6% of diabetic foot ulcers had healed (unadjusted odds ratio, 1.58; 95% confidence interval, 1.06-2.25; P = .02).

Study details: A multicenter, multinational, observer-blinded, randomized, controlled trial of 269 patients with hard-to-heal diabetic foot ulcers.

Disclosures: The trial was funded by Reapplix. Dr. Game reported receiving research funding from the company.

Sources: Game F et al. EASD 2018, Abstract 9.

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Claudication, CLI differ significantly in hospital readmission, costs, mortality

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Patients treated for claudication vs. critical limb ischemia (CLI) differed significantly in their initial cost of admission, readmission costs, length of stay (LOS), days to readmission, and mortality (during initial admission, as well as any admission), according to the results of a database analysis of more than 90,000 patients in the Nationwide Readmission Database.

©Andrei Malov/Thinkstock

Readmissions were influenced not only by the admission diagnosis and intervention performed “but more importantly and significantly by the patient’s characteristics such as age, sex, CCI [Charlson Comorbidity Index], and various other demographic factors,” wrote Rennier A. Martinez, MD, of JFK Medical Center, Atlantis, Fla., and his colleagues. The report was published in the October issue of Annals of Vascular Surgery.

The study used the International Classification of Diseases, Ninth Revision (ICD-9) codes and queried the Nationwide Readmission Database for 2013 and 2014 for all 92,769 adult patients admitted with the principal diagnosis of claudication (ICD-9 code 440.21; n = 33,055 patients) or CLI (ICD-9 code 440.22e440.24; n = 59,714 patients) who underwent percutaneous angioplasty (ICD-9 code 39.50, 39.90), peripheral bypass (ICD-9 code 39.29), or aortofemoral bypass (ICD-9 code 39.25).

The 30-day readmission rates were 9.0% for claudication and 19.3% for CLI. Similarly, the any readmission rates were 21.5% and 40.4% for claudication vs. CLI.

Significant differences were found for claudication and CLI, respectively, on initial cost of admission ($18,548 vs. $29,148), readmission costs ($14,726 vs. $17,681), LOS (4 days vs. 9 days), days to readmission (73 days vs. 59 days), mortality during initial admission (256 vs. 1,363), and mortality during any admission (538 vs. 3,838), all P less than .001.

Univariate and multivariate logistic regression analysis found that claudication, CLI, angioplasty, peripheral bypass, aortofemoral bypass, female sex, age younger than 65, Charlson Comorbidity Index, LOS, and primary expected payer status were all significant predictors of 30-day and overall readmissions at varying degrees.

The researchers also found that the five most common disease readmission groups were other vascular procedures (12.6%), amputation of lower limb except toes (6.3%), sepsis (5.4%), heart failure (4.9%), and postoperative or other device infections (4.8%) (Ann Vasc Surg. 2018;52:96-107).

The increased costs and higher levels of morbidity and mortality seen with CLI vs. claudication are not surprising given previous research showing that there are higher rates of complications in patients with CLI. A previous review showed there was a threefold higher risk of myocardial infarction, stroke, and vascular death in patients with CLI compared with patients with claudication, according Dr. Martinez and his colleagues.

“Readmissions after lower extremity procedures for patients admitted for claudication or CLI are influenced not only by the admission diagnosis and intervention performed but more importantly and significantly by the patient’s characteristics such as age, sex, CCI, and various other demographic factors,” the researchers wrote. “It is paramount to continue to perform this kind of study to better identify patients at risk for readmission and work toward prevention,” they concluded.

Dr. Martinez and his colleagues did not report disclosures, but indicated that the study did not receive any outside funding.

[email protected]

SOURCE: Martinez RA et al. Ann Vasc Surg. 2018;52:96-107.

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Patients treated for claudication vs. critical limb ischemia (CLI) differed significantly in their initial cost of admission, readmission costs, length of stay (LOS), days to readmission, and mortality (during initial admission, as well as any admission), according to the results of a database analysis of more than 90,000 patients in the Nationwide Readmission Database.

©Andrei Malov/Thinkstock

Readmissions were influenced not only by the admission diagnosis and intervention performed “but more importantly and significantly by the patient’s characteristics such as age, sex, CCI [Charlson Comorbidity Index], and various other demographic factors,” wrote Rennier A. Martinez, MD, of JFK Medical Center, Atlantis, Fla., and his colleagues. The report was published in the October issue of Annals of Vascular Surgery.

The study used the International Classification of Diseases, Ninth Revision (ICD-9) codes and queried the Nationwide Readmission Database for 2013 and 2014 for all 92,769 adult patients admitted with the principal diagnosis of claudication (ICD-9 code 440.21; n = 33,055 patients) or CLI (ICD-9 code 440.22e440.24; n = 59,714 patients) who underwent percutaneous angioplasty (ICD-9 code 39.50, 39.90), peripheral bypass (ICD-9 code 39.29), or aortofemoral bypass (ICD-9 code 39.25).

The 30-day readmission rates were 9.0% for claudication and 19.3% for CLI. Similarly, the any readmission rates were 21.5% and 40.4% for claudication vs. CLI.

Significant differences were found for claudication and CLI, respectively, on initial cost of admission ($18,548 vs. $29,148), readmission costs ($14,726 vs. $17,681), LOS (4 days vs. 9 days), days to readmission (73 days vs. 59 days), mortality during initial admission (256 vs. 1,363), and mortality during any admission (538 vs. 3,838), all P less than .001.

Univariate and multivariate logistic regression analysis found that claudication, CLI, angioplasty, peripheral bypass, aortofemoral bypass, female sex, age younger than 65, Charlson Comorbidity Index, LOS, and primary expected payer status were all significant predictors of 30-day and overall readmissions at varying degrees.

The researchers also found that the five most common disease readmission groups were other vascular procedures (12.6%), amputation of lower limb except toes (6.3%), sepsis (5.4%), heart failure (4.9%), and postoperative or other device infections (4.8%) (Ann Vasc Surg. 2018;52:96-107).

The increased costs and higher levels of morbidity and mortality seen with CLI vs. claudication are not surprising given previous research showing that there are higher rates of complications in patients with CLI. A previous review showed there was a threefold higher risk of myocardial infarction, stroke, and vascular death in patients with CLI compared with patients with claudication, according Dr. Martinez and his colleagues.

“Readmissions after lower extremity procedures for patients admitted for claudication or CLI are influenced not only by the admission diagnosis and intervention performed but more importantly and significantly by the patient’s characteristics such as age, sex, CCI, and various other demographic factors,” the researchers wrote. “It is paramount to continue to perform this kind of study to better identify patients at risk for readmission and work toward prevention,” they concluded.

Dr. Martinez and his colleagues did not report disclosures, but indicated that the study did not receive any outside funding.

[email protected]

SOURCE: Martinez RA et al. Ann Vasc Surg. 2018;52:96-107.

Patients treated for claudication vs. critical limb ischemia (CLI) differed significantly in their initial cost of admission, readmission costs, length of stay (LOS), days to readmission, and mortality (during initial admission, as well as any admission), according to the results of a database analysis of more than 90,000 patients in the Nationwide Readmission Database.

©Andrei Malov/Thinkstock

Readmissions were influenced not only by the admission diagnosis and intervention performed “but more importantly and significantly by the patient’s characteristics such as age, sex, CCI [Charlson Comorbidity Index], and various other demographic factors,” wrote Rennier A. Martinez, MD, of JFK Medical Center, Atlantis, Fla., and his colleagues. The report was published in the October issue of Annals of Vascular Surgery.

The study used the International Classification of Diseases, Ninth Revision (ICD-9) codes and queried the Nationwide Readmission Database for 2013 and 2014 for all 92,769 adult patients admitted with the principal diagnosis of claudication (ICD-9 code 440.21; n = 33,055 patients) or CLI (ICD-9 code 440.22e440.24; n = 59,714 patients) who underwent percutaneous angioplasty (ICD-9 code 39.50, 39.90), peripheral bypass (ICD-9 code 39.29), or aortofemoral bypass (ICD-9 code 39.25).

The 30-day readmission rates were 9.0% for claudication and 19.3% for CLI. Similarly, the any readmission rates were 21.5% and 40.4% for claudication vs. CLI.

Significant differences were found for claudication and CLI, respectively, on initial cost of admission ($18,548 vs. $29,148), readmission costs ($14,726 vs. $17,681), LOS (4 days vs. 9 days), days to readmission (73 days vs. 59 days), mortality during initial admission (256 vs. 1,363), and mortality during any admission (538 vs. 3,838), all P less than .001.

Univariate and multivariate logistic regression analysis found that claudication, CLI, angioplasty, peripheral bypass, aortofemoral bypass, female sex, age younger than 65, Charlson Comorbidity Index, LOS, and primary expected payer status were all significant predictors of 30-day and overall readmissions at varying degrees.

The researchers also found that the five most common disease readmission groups were other vascular procedures (12.6%), amputation of lower limb except toes (6.3%), sepsis (5.4%), heart failure (4.9%), and postoperative or other device infections (4.8%) (Ann Vasc Surg. 2018;52:96-107).

The increased costs and higher levels of morbidity and mortality seen with CLI vs. claudication are not surprising given previous research showing that there are higher rates of complications in patients with CLI. A previous review showed there was a threefold higher risk of myocardial infarction, stroke, and vascular death in patients with CLI compared with patients with claudication, according Dr. Martinez and his colleagues.

“Readmissions after lower extremity procedures for patients admitted for claudication or CLI are influenced not only by the admission diagnosis and intervention performed but more importantly and significantly by the patient’s characteristics such as age, sex, CCI, and various other demographic factors,” the researchers wrote. “It is paramount to continue to perform this kind of study to better identify patients at risk for readmission and work toward prevention,” they concluded.

Dr. Martinez and his colleagues did not report disclosures, but indicated that the study did not receive any outside funding.

[email protected]

SOURCE: Martinez RA et al. Ann Vasc Surg. 2018;52:96-107.

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Key clinical point: CLI was significantly more expensive and showed higher mortality rates compared with claudication.

Major finding: The 30-day readmission/any readmission rate was 9.0%/21.5% and 19.3%/40.4%, for claudication and CLI, respectively.

Study details: An analysis of more than 90,000 patients in the Nationwide Readmission Database in 2013 and 2014.

Disclosures: The authors did not report disclosures but indicated that the study did not receive any outside funding.

Source: Martinez RA et al. Ann Vasc Surg. 2018;52:96-107.

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Helping alleviate hospitalist burnout

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Focus on systemic factors

 

For hospitalists, burnout is a widespread and ongoing problem. In 2011, a Mayo Clinic study found that 45% of U.S. physicians had at least one symptom of professional burnout; by 2014, that number had risen to 54%.

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“Burnout among physicians has been shown to be linked to quality of care, impacting medical errors, mortality ratios in hospitalized patients, and lower patient satisfaction,” said Ingrid T. Katz, MD, MHS, assistant professor of medicine at Harvard Medical School, Boston, and coauthor of a recent column on the subject published in the New England Journal of Medicine.

Widespread burnout is caused by systemic factors, not individual failures. “These systemic factors range from excessive clerical burden to ‘work beyond work,’ where people end up taking work home at night and are often found interfacing with the EHR well after their normal work day,” Dr. Katz said. “Many also express their disdain for the model of practice that no longer values autonomy, which was seen as inherent in the profession prior to the current model of care.”

Moving towards a better framework would require an inherent trust in physicians, limiting unnecessary intrusions into a physician’s practice that do not impact medical care. “It would remove the burden of excessive documentation and allow for physicians to get reinspired by the practice of medicine, an inherently altruistic profession,” Dr. Katz said.

Changes might include eliminating excessive clerical demands and improving EHRs to allow physicians to return to the bedside. Workloads would be geared towards quality in care and not focused on improving the bottom line of a health care system. One health system Dr. Katz wrote about instituted a team-based model; under this system medical assistants gather data and reconcile medications, allowing physicians to focus on performing physical exams and making medical decisions.

“Burnout will diminish when physicians are empowered to be part of the solution and hospital systems make changes that recognize the totality of the challenges that physicians face,” Dr. Katz said, adding that hospitalists are in a unique position to promote such changes on a systemic level. “Leadership needs to be willing to inform and engage their physicians, monitor well-being of physicians as closely as they monitor quality in care, and implement changes when needed.”

Reference

1. Katz IT et al. Beyond Burnout – Redesigning Care to Restore Meaning and Sanity for Physicians. N Engl J Med. 2018 Jan 25. doi: 10.1056/NEJMp1716845.

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Focus on systemic factors

Focus on systemic factors

 

For hospitalists, burnout is a widespread and ongoing problem. In 2011, a Mayo Clinic study found that 45% of U.S. physicians had at least one symptom of professional burnout; by 2014, that number had risen to 54%.

shutteratakan/Thinkstock

“Burnout among physicians has been shown to be linked to quality of care, impacting medical errors, mortality ratios in hospitalized patients, and lower patient satisfaction,” said Ingrid T. Katz, MD, MHS, assistant professor of medicine at Harvard Medical School, Boston, and coauthor of a recent column on the subject published in the New England Journal of Medicine.

Widespread burnout is caused by systemic factors, not individual failures. “These systemic factors range from excessive clerical burden to ‘work beyond work,’ where people end up taking work home at night and are often found interfacing with the EHR well after their normal work day,” Dr. Katz said. “Many also express their disdain for the model of practice that no longer values autonomy, which was seen as inherent in the profession prior to the current model of care.”

Moving towards a better framework would require an inherent trust in physicians, limiting unnecessary intrusions into a physician’s practice that do not impact medical care. “It would remove the burden of excessive documentation and allow for physicians to get reinspired by the practice of medicine, an inherently altruistic profession,” Dr. Katz said.

Changes might include eliminating excessive clerical demands and improving EHRs to allow physicians to return to the bedside. Workloads would be geared towards quality in care and not focused on improving the bottom line of a health care system. One health system Dr. Katz wrote about instituted a team-based model; under this system medical assistants gather data and reconcile medications, allowing physicians to focus on performing physical exams and making medical decisions.

“Burnout will diminish when physicians are empowered to be part of the solution and hospital systems make changes that recognize the totality of the challenges that physicians face,” Dr. Katz said, adding that hospitalists are in a unique position to promote such changes on a systemic level. “Leadership needs to be willing to inform and engage their physicians, monitor well-being of physicians as closely as they monitor quality in care, and implement changes when needed.”

Reference

1. Katz IT et al. Beyond Burnout – Redesigning Care to Restore Meaning and Sanity for Physicians. N Engl J Med. 2018 Jan 25. doi: 10.1056/NEJMp1716845.

 

For hospitalists, burnout is a widespread and ongoing problem. In 2011, a Mayo Clinic study found that 45% of U.S. physicians had at least one symptom of professional burnout; by 2014, that number had risen to 54%.

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“Burnout among physicians has been shown to be linked to quality of care, impacting medical errors, mortality ratios in hospitalized patients, and lower patient satisfaction,” said Ingrid T. Katz, MD, MHS, assistant professor of medicine at Harvard Medical School, Boston, and coauthor of a recent column on the subject published in the New England Journal of Medicine.

Widespread burnout is caused by systemic factors, not individual failures. “These systemic factors range from excessive clerical burden to ‘work beyond work,’ where people end up taking work home at night and are often found interfacing with the EHR well after their normal work day,” Dr. Katz said. “Many also express their disdain for the model of practice that no longer values autonomy, which was seen as inherent in the profession prior to the current model of care.”

Moving towards a better framework would require an inherent trust in physicians, limiting unnecessary intrusions into a physician’s practice that do not impact medical care. “It would remove the burden of excessive documentation and allow for physicians to get reinspired by the practice of medicine, an inherently altruistic profession,” Dr. Katz said.

Changes might include eliminating excessive clerical demands and improving EHRs to allow physicians to return to the bedside. Workloads would be geared towards quality in care and not focused on improving the bottom line of a health care system. One health system Dr. Katz wrote about instituted a team-based model; under this system medical assistants gather data and reconcile medications, allowing physicians to focus on performing physical exams and making medical decisions.

“Burnout will diminish when physicians are empowered to be part of the solution and hospital systems make changes that recognize the totality of the challenges that physicians face,” Dr. Katz said, adding that hospitalists are in a unique position to promote such changes on a systemic level. “Leadership needs to be willing to inform and engage their physicians, monitor well-being of physicians as closely as they monitor quality in care, and implement changes when needed.”

Reference

1. Katz IT et al. Beyond Burnout – Redesigning Care to Restore Meaning and Sanity for Physicians. N Engl J Med. 2018 Jan 25. doi: 10.1056/NEJMp1716845.

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ACIP supports hepatitis A vaccine for homeless individuals

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Homeless individuals aged 1 year and older should be vaccinated against hepatitis A, based on a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

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“It is important that we take a national approach to vaccinating homeless” people, Noele Nelson, MD, PhD, MPH, of the CDC’s Division of Viral Hepatitis, said in a presentation prior to the vote, in which all 11 committee members voted in favor of hepatitis A vaccination for the homeless population.

Even limited vaccination will increase the herd immunity of the homeless population over time, she said.

Dr. Nelson presented data on the pros and cons of routine hepatitis A vaccination for homeless individuals aged 1 year and older. The Hepatitis Vaccines Work Group convened four meetings in advance of the October ACIP meeting and reached a consensus that homelessness is an independent indication for hepatitis A vaccination, she said.

If the hepatitis A vaccine is included as an ACIP recommendation, “it is more likely to be considered by homeless service providers,” noted Dr. Nelson. She also cited a low quality of evidence for adverse events associated with hepatitis A vaccination.

The work group considerations in the wake of a nationwide hepatitis A outbreak earlier in 2018 included the challenges of controlling outbreaks, which can spread quickly among the homeless population because of poor personal hygiene, limited sanitation, and tight living quarters. These factors make the homeless population more reliant on a vaccine for protection. An outbreak in San Diego, Calif., in particular, occurred largely in the homeless population.

“Routine vaccination is a more feasible approach to reach the homeless over time through regular homeless care providers,” Dr. Nelson said. As for costs, integrating vaccination into routine care for the homeless is cheaper and much less disruptive than the cost of responding to an outbreak.

The “cons” of recommending routine hepatitis A vaccination for the homeless population included the challenges of administrative record keeping. However, during the public comment period, Mae Morgan, MD, an internist who is medical director of Mercy Care Decatur Street & City of Refuge in Atlanta, emphasized that local homeless care organizations have procedures to manage routine vaccination. “If anyone is concerned that there is not a network in place, there are health centers to do this [that] would implement the vaccine.”

The ACIP committee members had no financial conflicts to disclose.

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Homeless individuals aged 1 year and older should be vaccinated against hepatitis A, based on a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

©vchal/Thinkstock

“It is important that we take a national approach to vaccinating homeless” people, Noele Nelson, MD, PhD, MPH, of the CDC’s Division of Viral Hepatitis, said in a presentation prior to the vote, in which all 11 committee members voted in favor of hepatitis A vaccination for the homeless population.

Even limited vaccination will increase the herd immunity of the homeless population over time, she said.

Dr. Nelson presented data on the pros and cons of routine hepatitis A vaccination for homeless individuals aged 1 year and older. The Hepatitis Vaccines Work Group convened four meetings in advance of the October ACIP meeting and reached a consensus that homelessness is an independent indication for hepatitis A vaccination, she said.

If the hepatitis A vaccine is included as an ACIP recommendation, “it is more likely to be considered by homeless service providers,” noted Dr. Nelson. She also cited a low quality of evidence for adverse events associated with hepatitis A vaccination.

The work group considerations in the wake of a nationwide hepatitis A outbreak earlier in 2018 included the challenges of controlling outbreaks, which can spread quickly among the homeless population because of poor personal hygiene, limited sanitation, and tight living quarters. These factors make the homeless population more reliant on a vaccine for protection. An outbreak in San Diego, Calif., in particular, occurred largely in the homeless population.

“Routine vaccination is a more feasible approach to reach the homeless over time through regular homeless care providers,” Dr. Nelson said. As for costs, integrating vaccination into routine care for the homeless is cheaper and much less disruptive than the cost of responding to an outbreak.

The “cons” of recommending routine hepatitis A vaccination for the homeless population included the challenges of administrative record keeping. However, during the public comment period, Mae Morgan, MD, an internist who is medical director of Mercy Care Decatur Street & City of Refuge in Atlanta, emphasized that local homeless care organizations have procedures to manage routine vaccination. “If anyone is concerned that there is not a network in place, there are health centers to do this [that] would implement the vaccine.”

The ACIP committee members had no financial conflicts to disclose.

 

Homeless individuals aged 1 year and older should be vaccinated against hepatitis A, based on a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

©vchal/Thinkstock

“It is important that we take a national approach to vaccinating homeless” people, Noele Nelson, MD, PhD, MPH, of the CDC’s Division of Viral Hepatitis, said in a presentation prior to the vote, in which all 11 committee members voted in favor of hepatitis A vaccination for the homeless population.

Even limited vaccination will increase the herd immunity of the homeless population over time, she said.

Dr. Nelson presented data on the pros and cons of routine hepatitis A vaccination for homeless individuals aged 1 year and older. The Hepatitis Vaccines Work Group convened four meetings in advance of the October ACIP meeting and reached a consensus that homelessness is an independent indication for hepatitis A vaccination, she said.

If the hepatitis A vaccine is included as an ACIP recommendation, “it is more likely to be considered by homeless service providers,” noted Dr. Nelson. She also cited a low quality of evidence for adverse events associated with hepatitis A vaccination.

The work group considerations in the wake of a nationwide hepatitis A outbreak earlier in 2018 included the challenges of controlling outbreaks, which can spread quickly among the homeless population because of poor personal hygiene, limited sanitation, and tight living quarters. These factors make the homeless population more reliant on a vaccine for protection. An outbreak in San Diego, Calif., in particular, occurred largely in the homeless population.

“Routine vaccination is a more feasible approach to reach the homeless over time through regular homeless care providers,” Dr. Nelson said. As for costs, integrating vaccination into routine care for the homeless is cheaper and much less disruptive than the cost of responding to an outbreak.

The “cons” of recommending routine hepatitis A vaccination for the homeless population included the challenges of administrative record keeping. However, during the public comment period, Mae Morgan, MD, an internist who is medical director of Mercy Care Decatur Street & City of Refuge in Atlanta, emphasized that local homeless care organizations have procedures to manage routine vaccination. “If anyone is concerned that there is not a network in place, there are health centers to do this [that] would implement the vaccine.”

The ACIP committee members had no financial conflicts to disclose.

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Swollen knee in a kid? Above 9, treat for Lyme

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SAN FRANCISCO– There’s no need to wait for western blot results to differentiate Lyme arthritis from septic arthritis in children, as long as your lab, like many, uses the Liaison Borrelia burgdorferi assay, according to investigators at the University of Minnesota, Minneapolis.

M. Alexander Otto/MDedge News
Dr. Bazak Sharon

Acute, isolated monoarthritis presents with a single swollen joint and pain whether it’s due to Lyme disease or infection, so it’s hard to tell them apart. Current guidelines recommend a two-tier approach to diagnose Lyme arthritis, an initial blood screen followed by western blot confirmation. Screening results come back in a few hours, but western blot confirmation can take days.

In the meantime, children are treated presumptively for the more concerning diagnosis – septic arthritis – which means hospitalization, surgical drainage, and IV antibiotics. Those who turn out to have Lyme are exposed to the risks and costs of unnecessary treatment and delays to proper diagnosis and doxycycline.

When “kids come in with a swollen knee, maybe 10% or 15% end up in the hospital being treated for septic arthritis that they never had. I wanted to see if we can diagnose Lyme arthritis more quickly,” said lead investigator Bazak Sharon, MD, a pediatric infectious disease specialist at the university’s Masonic Children’s Hospital.

Masonic and its affiliated health system use the Liaison Borrelia burgdorferi assay (DiaSorin) to screen for Lyme, and a careful parsing of the results seems to solve the problem.

Liaison is a chemiluminescence immunoassay that uses light to measure IgM and IgG antibodies to a B. burgdorferi surface protein in serum samples. Results are reported as relative light units (RLUs); below 0.9 RLUs is negative; 0.9-1.1 is equivocal, and over 1.1 is positive.

It’s where patients fall in the range of positivity that matters when it comes to differentiating Lyme from septic arthritis, Dr. Sharon said at ID Week, an annual scientific meeting on infectious diseases (Clin Vaccine Immunol. 2008 Dec;15[12]:1796-804).

He and his team reviewed 60 cases of acute, isolated monoarthritis culled from more than 700 children who presented with joint complaints from 2011 to 2016; 47 had Lyme arthritis confirmed by western blot; 13 had septic arthritis.

It turned out that “every single patient with a” Liaison value of 9 RLUs or higher was confirmed on western blot for Lyme. “Under 9, there was not a single case of Lyme arthritis,” Dr. Sharon said. Three other patients with acute arthritis also tested positive on the screen, but their RLU values were below 4; two turned out to be trauma related and one was ultimately diagnosed with juvenile idiopathic arthritis. Western blots were negative in all three.

The RLU number reported on the screening test “appears to correlate very well with Lyme arthritis. In an otherwise healthy child presenting with acute joint swelling, utilizing this screening test can confirm clinical suspicion of Lyme arthritis within hours, and prevent the potential harmful interventions accompanying a misdiagnosis of septic arthritis. Just do the screening. If it comes up above 9, you’ve got Lyme arthritis,” and don’t need to wait for western blot results to treat, Dr. Sharon said.

In other words, above 9, treat for Lyme.

The investigators plan to delve further into their results with sensitivity/specificity and other analyses before publishing. Ultimately, “my goal is to have a better diagnosis algorithm for kids who present with acute, isolated monoarthritis,” Dr. Sharon said.

There was no industry funding for the work, and the investigators didn’t have any disclosures.
 

SOURCE: Sharon B et al. 2018 ID Week abstract 286.

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SAN FRANCISCO– There’s no need to wait for western blot results to differentiate Lyme arthritis from septic arthritis in children, as long as your lab, like many, uses the Liaison Borrelia burgdorferi assay, according to investigators at the University of Minnesota, Minneapolis.

M. Alexander Otto/MDedge News
Dr. Bazak Sharon

Acute, isolated monoarthritis presents with a single swollen joint and pain whether it’s due to Lyme disease or infection, so it’s hard to tell them apart. Current guidelines recommend a two-tier approach to diagnose Lyme arthritis, an initial blood screen followed by western blot confirmation. Screening results come back in a few hours, but western blot confirmation can take days.

In the meantime, children are treated presumptively for the more concerning diagnosis – septic arthritis – which means hospitalization, surgical drainage, and IV antibiotics. Those who turn out to have Lyme are exposed to the risks and costs of unnecessary treatment and delays to proper diagnosis and doxycycline.

When “kids come in with a swollen knee, maybe 10% or 15% end up in the hospital being treated for septic arthritis that they never had. I wanted to see if we can diagnose Lyme arthritis more quickly,” said lead investigator Bazak Sharon, MD, a pediatric infectious disease specialist at the university’s Masonic Children’s Hospital.

Masonic and its affiliated health system use the Liaison Borrelia burgdorferi assay (DiaSorin) to screen for Lyme, and a careful parsing of the results seems to solve the problem.

Liaison is a chemiluminescence immunoassay that uses light to measure IgM and IgG antibodies to a B. burgdorferi surface protein in serum samples. Results are reported as relative light units (RLUs); below 0.9 RLUs is negative; 0.9-1.1 is equivocal, and over 1.1 is positive.

It’s where patients fall in the range of positivity that matters when it comes to differentiating Lyme from septic arthritis, Dr. Sharon said at ID Week, an annual scientific meeting on infectious diseases (Clin Vaccine Immunol. 2008 Dec;15[12]:1796-804).

He and his team reviewed 60 cases of acute, isolated monoarthritis culled from more than 700 children who presented with joint complaints from 2011 to 2016; 47 had Lyme arthritis confirmed by western blot; 13 had septic arthritis.

It turned out that “every single patient with a” Liaison value of 9 RLUs or higher was confirmed on western blot for Lyme. “Under 9, there was not a single case of Lyme arthritis,” Dr. Sharon said. Three other patients with acute arthritis also tested positive on the screen, but their RLU values were below 4; two turned out to be trauma related and one was ultimately diagnosed with juvenile idiopathic arthritis. Western blots were negative in all three.

The RLU number reported on the screening test “appears to correlate very well with Lyme arthritis. In an otherwise healthy child presenting with acute joint swelling, utilizing this screening test can confirm clinical suspicion of Lyme arthritis within hours, and prevent the potential harmful interventions accompanying a misdiagnosis of septic arthritis. Just do the screening. If it comes up above 9, you’ve got Lyme arthritis,” and don’t need to wait for western blot results to treat, Dr. Sharon said.

In other words, above 9, treat for Lyme.

The investigators plan to delve further into their results with sensitivity/specificity and other analyses before publishing. Ultimately, “my goal is to have a better diagnosis algorithm for kids who present with acute, isolated monoarthritis,” Dr. Sharon said.

There was no industry funding for the work, and the investigators didn’t have any disclosures.
 

SOURCE: Sharon B et al. 2018 ID Week abstract 286.

 

SAN FRANCISCO– There’s no need to wait for western blot results to differentiate Lyme arthritis from septic arthritis in children, as long as your lab, like many, uses the Liaison Borrelia burgdorferi assay, according to investigators at the University of Minnesota, Minneapolis.

M. Alexander Otto/MDedge News
Dr. Bazak Sharon

Acute, isolated monoarthritis presents with a single swollen joint and pain whether it’s due to Lyme disease or infection, so it’s hard to tell them apart. Current guidelines recommend a two-tier approach to diagnose Lyme arthritis, an initial blood screen followed by western blot confirmation. Screening results come back in a few hours, but western blot confirmation can take days.

In the meantime, children are treated presumptively for the more concerning diagnosis – septic arthritis – which means hospitalization, surgical drainage, and IV antibiotics. Those who turn out to have Lyme are exposed to the risks and costs of unnecessary treatment and delays to proper diagnosis and doxycycline.

When “kids come in with a swollen knee, maybe 10% or 15% end up in the hospital being treated for septic arthritis that they never had. I wanted to see if we can diagnose Lyme arthritis more quickly,” said lead investigator Bazak Sharon, MD, a pediatric infectious disease specialist at the university’s Masonic Children’s Hospital.

Masonic and its affiliated health system use the Liaison Borrelia burgdorferi assay (DiaSorin) to screen for Lyme, and a careful parsing of the results seems to solve the problem.

Liaison is a chemiluminescence immunoassay that uses light to measure IgM and IgG antibodies to a B. burgdorferi surface protein in serum samples. Results are reported as relative light units (RLUs); below 0.9 RLUs is negative; 0.9-1.1 is equivocal, and over 1.1 is positive.

It’s where patients fall in the range of positivity that matters when it comes to differentiating Lyme from septic arthritis, Dr. Sharon said at ID Week, an annual scientific meeting on infectious diseases (Clin Vaccine Immunol. 2008 Dec;15[12]:1796-804).

He and his team reviewed 60 cases of acute, isolated monoarthritis culled from more than 700 children who presented with joint complaints from 2011 to 2016; 47 had Lyme arthritis confirmed by western blot; 13 had septic arthritis.

It turned out that “every single patient with a” Liaison value of 9 RLUs or higher was confirmed on western blot for Lyme. “Under 9, there was not a single case of Lyme arthritis,” Dr. Sharon said. Three other patients with acute arthritis also tested positive on the screen, but their RLU values were below 4; two turned out to be trauma related and one was ultimately diagnosed with juvenile idiopathic arthritis. Western blots were negative in all three.

The RLU number reported on the screening test “appears to correlate very well with Lyme arthritis. In an otherwise healthy child presenting with acute joint swelling, utilizing this screening test can confirm clinical suspicion of Lyme arthritis within hours, and prevent the potential harmful interventions accompanying a misdiagnosis of septic arthritis. Just do the screening. If it comes up above 9, you’ve got Lyme arthritis,” and don’t need to wait for western blot results to treat, Dr. Sharon said.

In other words, above 9, treat for Lyme.

The investigators plan to delve further into their results with sensitivity/specificity and other analyses before publishing. Ultimately, “my goal is to have a better diagnosis algorithm for kids who present with acute, isolated monoarthritis,” Dr. Sharon said.

There was no industry funding for the work, and the investigators didn’t have any disclosures.
 

SOURCE: Sharon B et al. 2018 ID Week abstract 286.

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Key clinical point: If your lab uses the Liaison Borrelia burgdorferi assay, there’s no need to wait for western blot results to differentiate Lyme arthritis from septic arthritis.

Major finding: There was not a single case of Lyme arthritis under 9 RLUs on the screening test.

Study details: Review of 60 children with acute, isolated monoarthritis, culled from more than 700 with joint complaints.

Disclosures: There was no industry funding for the work, and the investigators didn’t have any disclosures.

Source: Sharon B et al. 2018 ID Week abstract 286.

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FDA approves Xofluza for treatment of influenza

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The Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for 48 hours or less.

The FDA approval is based on results from two randomized, clinical trials. In both trials, patients who received Xofluza experienced a shorter duration until alleviation of symptoms, compared with patients who received a placebo. In the second trial, patients who received Xofluza and patients who received another approved antiviral influenza medication experienced similar durations until symptom alleviation.

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The most common adverse events associated with Xofluza were diarrhea and bronchitis.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, MD, added. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”

Find the full press release on the FDA website.

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The Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for 48 hours or less.

The FDA approval is based on results from two randomized, clinical trials. In both trials, patients who received Xofluza experienced a shorter duration until alleviation of symptoms, compared with patients who received a placebo. In the second trial, patients who received Xofluza and patients who received another approved antiviral influenza medication experienced similar durations until symptom alleviation.

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The most common adverse events associated with Xofluza were diarrhea and bronchitis.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, MD, added. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”

Find the full press release on the FDA website.

 

The Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for 48 hours or less.

The FDA approval is based on results from two randomized, clinical trials. In both trials, patients who received Xofluza experienced a shorter duration until alleviation of symptoms, compared with patients who received a placebo. In the second trial, patients who received Xofluza and patients who received another approved antiviral influenza medication experienced similar durations until symptom alleviation.

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The most common adverse events associated with Xofluza were diarrhea and bronchitis.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, MD, added. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”

Find the full press release on the FDA website.

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Older age predicts mortality after alloHCT in NHL, but not relapse

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Elderly patients with non-Hodgkin lymphoma (NHL) are more likely to die, but not relapse, within 1 year of allogeneic hematopoietic cell transplantation (alloHCT), compared with younger or middle-age patients, according to investigators.

copyright claudiobaba/iStockPhoto.com

Comorbidities also increased risks of nonrelapse mortality (NRM) at 1 year, but to a lesser extent than that of elderly status, reported lead author Charalampia Kyriakou, MD, PhD, of the department of haematology at University College London Hospital and London North West University Healthcare NHS Trust, and her colleagues.

“Although alloHCT is feasible and effective in very old patients, the increased NRM risk must be taken into account when assessing the indication for alloHCT for NHL in this age group,” the investigators wrote in Biology of Blood and Marrow Transplantation.

This decision is becoming more common, they noted. “With the advent of reduced-intensity conditioning (RIC) strategies and other improvements in transplantation technology, alloHCT is being increasingly considered in elderly patients with [relapsed and refractory] NHL.”

The retrospective study analyzed 3,919 patients with NHL who underwent alloHCT between 2003 and 2013. Patients were sorted into three age groups: young (18-50 years), middle age (51-65 years), or elderly (66-77 years).

Disease types also were reported: 1,461 patients had follicular lymphoma (FL; 37%), 1,192 had diffuse large B cell lymphoma (DLBCL; 30%), 823 had mantle cell lymphoma (MCL; 21%), and 443 had peripheral T cell lymphoma (PTCL; 11%).

At the time of alloHCT, about 85% of patients were chemosensitive, with the remainder being chemorefractory. The age groups had similar patient characteristics, with exceptions noted for unrelated donors, MCL, and RIC, which became increasingly overrepresented with age.

The results showed that NRM at 1 year was 13% for young patients, 20% for middle-age patients, and 33% for elderly patients (P less than .001). Overall survival at 3 years followed an inverse trend, decreasing with age from 60% in young patients to 54% in middle-age patients, before dropping more dramatically to 38% in the elderly (P less than .001).

In contrast to these significant associations between age and survival, relapse risk at 3 years remained relatively consistent, with young patients at 30%, middle-age patients at 31%, and elderly patients at 28% (P = .355).

The investigators noted that the risk of NRM increased most dramatically between middle age and old age, with less significant differences between the middle-age and young groups. They suggested that “age per se should have a limited impact on the indication for alloHCT for NHL in patients up to age 65 years.”

The increased risk with elderly status could not be fully explained by comorbidities, although these were more common in elderly patients. After analyzing information from a subset of patients, the investigators concluded that “the presence of comorbidities is a significant risk factor for NRM and survival, but this does not fully explain the outcome disadvantages in our [elderly] group.” Therefore, age remains an independent risk factor.

“The information provided in this cohort of patients with NHL, the largest reported to date, is useful and relevant, especially in the era of evolving therapies,” the investigators wrote. They added that the information is “even more relevant now with the availability of treatment with ... chimeric antigen receptor (CAR) T cells ... after relapse post-alloHCT.”

The investigators reported having no financial disclosures.

SOURCE: Kyriakou C et al. Biol Blood Marrow Transplant. 2018 Sep 13. doi: 10.1016/j.bbmt.2018.08.025.

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Elderly patients with non-Hodgkin lymphoma (NHL) are more likely to die, but not relapse, within 1 year of allogeneic hematopoietic cell transplantation (alloHCT), compared with younger or middle-age patients, according to investigators.

copyright claudiobaba/iStockPhoto.com

Comorbidities also increased risks of nonrelapse mortality (NRM) at 1 year, but to a lesser extent than that of elderly status, reported lead author Charalampia Kyriakou, MD, PhD, of the department of haematology at University College London Hospital and London North West University Healthcare NHS Trust, and her colleagues.

“Although alloHCT is feasible and effective in very old patients, the increased NRM risk must be taken into account when assessing the indication for alloHCT for NHL in this age group,” the investigators wrote in Biology of Blood and Marrow Transplantation.

This decision is becoming more common, they noted. “With the advent of reduced-intensity conditioning (RIC) strategies and other improvements in transplantation technology, alloHCT is being increasingly considered in elderly patients with [relapsed and refractory] NHL.”

The retrospective study analyzed 3,919 patients with NHL who underwent alloHCT between 2003 and 2013. Patients were sorted into three age groups: young (18-50 years), middle age (51-65 years), or elderly (66-77 years).

Disease types also were reported: 1,461 patients had follicular lymphoma (FL; 37%), 1,192 had diffuse large B cell lymphoma (DLBCL; 30%), 823 had mantle cell lymphoma (MCL; 21%), and 443 had peripheral T cell lymphoma (PTCL; 11%).

At the time of alloHCT, about 85% of patients were chemosensitive, with the remainder being chemorefractory. The age groups had similar patient characteristics, with exceptions noted for unrelated donors, MCL, and RIC, which became increasingly overrepresented with age.

The results showed that NRM at 1 year was 13% for young patients, 20% for middle-age patients, and 33% for elderly patients (P less than .001). Overall survival at 3 years followed an inverse trend, decreasing with age from 60% in young patients to 54% in middle-age patients, before dropping more dramatically to 38% in the elderly (P less than .001).

In contrast to these significant associations between age and survival, relapse risk at 3 years remained relatively consistent, with young patients at 30%, middle-age patients at 31%, and elderly patients at 28% (P = .355).

The investigators noted that the risk of NRM increased most dramatically between middle age and old age, with less significant differences between the middle-age and young groups. They suggested that “age per se should have a limited impact on the indication for alloHCT for NHL in patients up to age 65 years.”

The increased risk with elderly status could not be fully explained by comorbidities, although these were more common in elderly patients. After analyzing information from a subset of patients, the investigators concluded that “the presence of comorbidities is a significant risk factor for NRM and survival, but this does not fully explain the outcome disadvantages in our [elderly] group.” Therefore, age remains an independent risk factor.

“The information provided in this cohort of patients with NHL, the largest reported to date, is useful and relevant, especially in the era of evolving therapies,” the investigators wrote. They added that the information is “even more relevant now with the availability of treatment with ... chimeric antigen receptor (CAR) T cells ... after relapse post-alloHCT.”

The investigators reported having no financial disclosures.

SOURCE: Kyriakou C et al. Biol Blood Marrow Transplant. 2018 Sep 13. doi: 10.1016/j.bbmt.2018.08.025.

 

Elderly patients with non-Hodgkin lymphoma (NHL) are more likely to die, but not relapse, within 1 year of allogeneic hematopoietic cell transplantation (alloHCT), compared with younger or middle-age patients, according to investigators.

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Comorbidities also increased risks of nonrelapse mortality (NRM) at 1 year, but to a lesser extent than that of elderly status, reported lead author Charalampia Kyriakou, MD, PhD, of the department of haematology at University College London Hospital and London North West University Healthcare NHS Trust, and her colleagues.

“Although alloHCT is feasible and effective in very old patients, the increased NRM risk must be taken into account when assessing the indication for alloHCT for NHL in this age group,” the investigators wrote in Biology of Blood and Marrow Transplantation.

This decision is becoming more common, they noted. “With the advent of reduced-intensity conditioning (RIC) strategies and other improvements in transplantation technology, alloHCT is being increasingly considered in elderly patients with [relapsed and refractory] NHL.”

The retrospective study analyzed 3,919 patients with NHL who underwent alloHCT between 2003 and 2013. Patients were sorted into three age groups: young (18-50 years), middle age (51-65 years), or elderly (66-77 years).

Disease types also were reported: 1,461 patients had follicular lymphoma (FL; 37%), 1,192 had diffuse large B cell lymphoma (DLBCL; 30%), 823 had mantle cell lymphoma (MCL; 21%), and 443 had peripheral T cell lymphoma (PTCL; 11%).

At the time of alloHCT, about 85% of patients were chemosensitive, with the remainder being chemorefractory. The age groups had similar patient characteristics, with exceptions noted for unrelated donors, MCL, and RIC, which became increasingly overrepresented with age.

The results showed that NRM at 1 year was 13% for young patients, 20% for middle-age patients, and 33% for elderly patients (P less than .001). Overall survival at 3 years followed an inverse trend, decreasing with age from 60% in young patients to 54% in middle-age patients, before dropping more dramatically to 38% in the elderly (P less than .001).

In contrast to these significant associations between age and survival, relapse risk at 3 years remained relatively consistent, with young patients at 30%, middle-age patients at 31%, and elderly patients at 28% (P = .355).

The investigators noted that the risk of NRM increased most dramatically between middle age and old age, with less significant differences between the middle-age and young groups. They suggested that “age per se should have a limited impact on the indication for alloHCT for NHL in patients up to age 65 years.”

The increased risk with elderly status could not be fully explained by comorbidities, although these were more common in elderly patients. After analyzing information from a subset of patients, the investigators concluded that “the presence of comorbidities is a significant risk factor for NRM and survival, but this does not fully explain the outcome disadvantages in our [elderly] group.” Therefore, age remains an independent risk factor.

“The information provided in this cohort of patients with NHL, the largest reported to date, is useful and relevant, especially in the era of evolving therapies,” the investigators wrote. They added that the information is “even more relevant now with the availability of treatment with ... chimeric antigen receptor (CAR) T cells ... after relapse post-alloHCT.”

The investigators reported having no financial disclosures.

SOURCE: Kyriakou C et al. Biol Blood Marrow Transplant. 2018 Sep 13. doi: 10.1016/j.bbmt.2018.08.025.

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Key clinical point: Elderly patients with non-Hodgkin lymphoma are more likely to die, but not relapse, within 1 year of allogeneic hematopoietic cell transplantation.

Major finding: One-year nonrelapse mortality (NRM) was 13% for young patients, 20% for middle-age patients, and 33% for elderly patients (P less than .001).

Study details: A retrospective analysis of 3,919 patients with NHL who underwent alloHCT between 2003 and 2013.

Disclosures: The researchers reported having no financial disclosures.

Source: Kyriakou C et al. Biol Blood Marrow Transplant. 2018 Sep 13. doi: 10.1016/j.bbmt.2018.08.025.

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Are women seeking short-acting contraception satisfied with LARC after giving it a try?

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Are women seeking short-acting contraception satisfied with LARC after giving it a try?

EXPERT COMMENTARY

Because of women’s personal preference and aversion, for various reasons, to LARC methods, the current estimated use rate of 17% for LARC methods would increase only to 24% to 29% even if major barriers, such as cost and availability, were removed.1 To gain more insight into this issue, Hubacher and colleagues sought to determine if LARC methods would meet the contraceptive needs and be acceptable to a population of women who were not seeking these methods actively and who might have some reservation about using them.

Details of the study

The authors approached women actively seeking 1 of the 2 SARC methods but not a LARC method for contraception. They enrolled 524 women into a cohort study in which they received their desired SARC method. In addition, 392 women agreed to be enrolled in a randomized clinical trial comparing women beginning a LARC method for the first time with a group receiving 1 of the 2 SARC methods.

Importance of covered costs. Of note, the women in the randomized trial had the costs of the insertion or removal of the LARC method covered; those randomly assigned to the comparative SARC arm had the costs of their oral contraceptives (OCs) or depot medroxyprogesterone acetate (DMPA) covered for the first year of use. Underwriting the costs in the randomized study was likely important for study recruitment, since 47% of participants who were randomized to the LARC group cited cost as one of the reasons they did not try a LARC method previously.

Satisfaction with contraceptive method. In addition to the differences in continuation rates and pregnancy rates noted, it is interesting that, among women who tried a LARC method and who had some persistent negative feelings about the method, 65.9% would try the method again.

Satisfaction levels were estimated using 3 choices, with “happiness” being the highest level of satisfaction, followed by “neutral” and “unhappy.” At 24 months, the number of women indicating happiness was similar among the 3 study groups: 71.4% for the LARC randomized group, 75.0% for the randomized SARC group, and 77.6% for the preferred SARC cohort group.

Among women who discontinued their LARC method, occurrence of adverse effects was the reason given 74.2% of the time, while among SARC method users in both groups there was no dominant reason for discontinuation. Also, among women who discontinued their method, the percentage indicating happiness was 32.2% for the LARC randomized group compared with 69.9% and 68.2% for the randomized and preference cohort SARC groups, respectively.
 

Study strengths and weaknesses

This study had several strengths. The population from which the study groups were obtained was demographically diverse and was appropriate for determining if women with reservations about LARC methods could have satisfactory outcomes similar to women who self-select LARC methods. Further, the 24 months of observations indicate that, for the most part, satisfaction persisted.

One of the study’s shortcomings is the limited data on the subsets, that is, the specific method chosen, within each of the study groups.

WHAT THIS EVIDENCE MEANS FOR PRACTICEWomen who use LARC methods, even if they have reservations about using them, have high efficacy and continuation rates compared with women using OCs or DMPA, as well as a high level of satisfaction, particularly when cost and access barriers are removed. Adequate balanced counseling about the advantages and disadvantages of LARC methods may convince some women who harbor concerns to try a LARC method if cost is not a significant barrier. Since adverse effects are the major reason for discontinuation, potential users should be counseled adequately about their occurrence and about the potential approaches that can be used to try to ameliorate them should they occur.
-- Ronald T. Burkman, MD

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. Foster DG, Barar R, Gould H, et al. Projections and opinions from 100 experts in long-acting reversible contraception. Contraception. 2015;92:543-552.
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Dr. Burkman is Emeritus Professor of Obstetrics and Gynecology, Tufts University School of Medicine, Baystate Medical Center, Springfield, Massachusetts.

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EXPERT COMMENTARY

Because of women’s personal preference and aversion, for various reasons, to LARC methods, the current estimated use rate of 17% for LARC methods would increase only to 24% to 29% even if major barriers, such as cost and availability, were removed.1 To gain more insight into this issue, Hubacher and colleagues sought to determine if LARC methods would meet the contraceptive needs and be acceptable to a population of women who were not seeking these methods actively and who might have some reservation about using them.

Details of the study

The authors approached women actively seeking 1 of the 2 SARC methods but not a LARC method for contraception. They enrolled 524 women into a cohort study in which they received their desired SARC method. In addition, 392 women agreed to be enrolled in a randomized clinical trial comparing women beginning a LARC method for the first time with a group receiving 1 of the 2 SARC methods.

Importance of covered costs. Of note, the women in the randomized trial had the costs of the insertion or removal of the LARC method covered; those randomly assigned to the comparative SARC arm had the costs of their oral contraceptives (OCs) or depot medroxyprogesterone acetate (DMPA) covered for the first year of use. Underwriting the costs in the randomized study was likely important for study recruitment, since 47% of participants who were randomized to the LARC group cited cost as one of the reasons they did not try a LARC method previously.

Satisfaction with contraceptive method. In addition to the differences in continuation rates and pregnancy rates noted, it is interesting that, among women who tried a LARC method and who had some persistent negative feelings about the method, 65.9% would try the method again.

Satisfaction levels were estimated using 3 choices, with “happiness” being the highest level of satisfaction, followed by “neutral” and “unhappy.” At 24 months, the number of women indicating happiness was similar among the 3 study groups: 71.4% for the LARC randomized group, 75.0% for the randomized SARC group, and 77.6% for the preferred SARC cohort group.

Among women who discontinued their LARC method, occurrence of adverse effects was the reason given 74.2% of the time, while among SARC method users in both groups there was no dominant reason for discontinuation. Also, among women who discontinued their method, the percentage indicating happiness was 32.2% for the LARC randomized group compared with 69.9% and 68.2% for the randomized and preference cohort SARC groups, respectively.
 

Study strengths and weaknesses

This study had several strengths. The population from which the study groups were obtained was demographically diverse and was appropriate for determining if women with reservations about LARC methods could have satisfactory outcomes similar to women who self-select LARC methods. Further, the 24 months of observations indicate that, for the most part, satisfaction persisted.

One of the study’s shortcomings is the limited data on the subsets, that is, the specific method chosen, within each of the study groups.

WHAT THIS EVIDENCE MEANS FOR PRACTICEWomen who use LARC methods, even if they have reservations about using them, have high efficacy and continuation rates compared with women using OCs or DMPA, as well as a high level of satisfaction, particularly when cost and access barriers are removed. Adequate balanced counseling about the advantages and disadvantages of LARC methods may convince some women who harbor concerns to try a LARC method if cost is not a significant barrier. Since adverse effects are the major reason for discontinuation, potential users should be counseled adequately about their occurrence and about the potential approaches that can be used to try to ameliorate them should they occur.
-- Ronald T. Burkman, MD

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Because of women’s personal preference and aversion, for various reasons, to LARC methods, the current estimated use rate of 17% for LARC methods would increase only to 24% to 29% even if major barriers, such as cost and availability, were removed.1 To gain more insight into this issue, Hubacher and colleagues sought to determine if LARC methods would meet the contraceptive needs and be acceptable to a population of women who were not seeking these methods actively and who might have some reservation about using them.

Details of the study

The authors approached women actively seeking 1 of the 2 SARC methods but not a LARC method for contraception. They enrolled 524 women into a cohort study in which they received their desired SARC method. In addition, 392 women agreed to be enrolled in a randomized clinical trial comparing women beginning a LARC method for the first time with a group receiving 1 of the 2 SARC methods.

Importance of covered costs. Of note, the women in the randomized trial had the costs of the insertion or removal of the LARC method covered; those randomly assigned to the comparative SARC arm had the costs of their oral contraceptives (OCs) or depot medroxyprogesterone acetate (DMPA) covered for the first year of use. Underwriting the costs in the randomized study was likely important for study recruitment, since 47% of participants who were randomized to the LARC group cited cost as one of the reasons they did not try a LARC method previously.

Satisfaction with contraceptive method. In addition to the differences in continuation rates and pregnancy rates noted, it is interesting that, among women who tried a LARC method and who had some persistent negative feelings about the method, 65.9% would try the method again.

Satisfaction levels were estimated using 3 choices, with “happiness” being the highest level of satisfaction, followed by “neutral” and “unhappy.” At 24 months, the number of women indicating happiness was similar among the 3 study groups: 71.4% for the LARC randomized group, 75.0% for the randomized SARC group, and 77.6% for the preferred SARC cohort group.

Among women who discontinued their LARC method, occurrence of adverse effects was the reason given 74.2% of the time, while among SARC method users in both groups there was no dominant reason for discontinuation. Also, among women who discontinued their method, the percentage indicating happiness was 32.2% for the LARC randomized group compared with 69.9% and 68.2% for the randomized and preference cohort SARC groups, respectively.
 

Study strengths and weaknesses

This study had several strengths. The population from which the study groups were obtained was demographically diverse and was appropriate for determining if women with reservations about LARC methods could have satisfactory outcomes similar to women who self-select LARC methods. Further, the 24 months of observations indicate that, for the most part, satisfaction persisted.

One of the study’s shortcomings is the limited data on the subsets, that is, the specific method chosen, within each of the study groups.

WHAT THIS EVIDENCE MEANS FOR PRACTICEWomen who use LARC methods, even if they have reservations about using them, have high efficacy and continuation rates compared with women using OCs or DMPA, as well as a high level of satisfaction, particularly when cost and access barriers are removed. Adequate balanced counseling about the advantages and disadvantages of LARC methods may convince some women who harbor concerns to try a LARC method if cost is not a significant barrier. Since adverse effects are the major reason for discontinuation, potential users should be counseled adequately about their occurrence and about the potential approaches that can be used to try to ameliorate them should they occur.
-- Ronald T. Burkman, MD

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. Foster DG, Barar R, Gould H, et al. Projections and opinions from 100 experts in long-acting reversible contraception. Contraception. 2015;92:543-552.
References
  1. Foster DG, Barar R, Gould H, et al. Projections and opinions from 100 experts in long-acting reversible contraception. Contraception. 2015;92:543-552.
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FFR by wire may soon be obsolete

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SAN DIEGO– Angiograms can be deceiving, so it’s best to measure fractional flow reserve (FFR) across coronary obstructions to gauge patients’ true need for intervention. That’s hardly news to cardiologists, but FFR is not often done. The problem is that traditional measurement requires threading wires down coronary arteries; the technique is a bit risky and takes time and training. It also has to be repeated for each lesion.
 

But now, several companies are developing noninvasive ways to measure FFR.

Findings from one of them, CathWorks, were presented at the Transcatheter Cardiovascular Therapeutics annual meeting sponsored by the Cardiovascular Research Foundation. Its FFRangio system uses high-quality angiograms and an algorithm to estimate resistance and flow across stenoses. After a few cases, the process takes less than 5 minutes (Circulation. 2018 Sep 24. doi: 10.1161/CIRCULATIONAHA.118.037350).

“I think this is a big breakthrough. ... Ultimately, it should lead to better patient outcomes,” said lead investigator William Fearon, MD, professor of cardiology at Stanford University, Calif.

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SAN DIEGO– Angiograms can be deceiving, so it’s best to measure fractional flow reserve (FFR) across coronary obstructions to gauge patients’ true need for intervention. That’s hardly news to cardiologists, but FFR is not often done. The problem is that traditional measurement requires threading wires down coronary arteries; the technique is a bit risky and takes time and training. It also has to be repeated for each lesion.
 

But now, several companies are developing noninvasive ways to measure FFR.

Findings from one of them, CathWorks, were presented at the Transcatheter Cardiovascular Therapeutics annual meeting sponsored by the Cardiovascular Research Foundation. Its FFRangio system uses high-quality angiograms and an algorithm to estimate resistance and flow across stenoses. After a few cases, the process takes less than 5 minutes (Circulation. 2018 Sep 24. doi: 10.1161/CIRCULATIONAHA.118.037350).

“I think this is a big breakthrough. ... Ultimately, it should lead to better patient outcomes,” said lead investigator William Fearon, MD, professor of cardiology at Stanford University, Calif.

SAN DIEGO– Angiograms can be deceiving, so it’s best to measure fractional flow reserve (FFR) across coronary obstructions to gauge patients’ true need for intervention. That’s hardly news to cardiologists, but FFR is not often done. The problem is that traditional measurement requires threading wires down coronary arteries; the technique is a bit risky and takes time and training. It also has to be repeated for each lesion.
 

But now, several companies are developing noninvasive ways to measure FFR.

Findings from one of them, CathWorks, were presented at the Transcatheter Cardiovascular Therapeutics annual meeting sponsored by the Cardiovascular Research Foundation. Its FFRangio system uses high-quality angiograms and an algorithm to estimate resistance and flow across stenoses. After a few cases, the process takes less than 5 minutes (Circulation. 2018 Sep 24. doi: 10.1161/CIRCULATIONAHA.118.037350).

“I think this is a big breakthrough. ... Ultimately, it should lead to better patient outcomes,” said lead investigator William Fearon, MD, professor of cardiology at Stanford University, Calif.

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REPORTING FROM TCT 2018

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