Pediculosis pubis, also known as pubic lice, or “crabs,” is an infestation of Phthirus pubis. Crab lice are spread sexually and through close skin contact, as well as contaminated clothes and bedding. Adult lice can live up to 36 hours away from its host. Pubic areas most commonly are affected, although other hair-bearing parts of the body often are affected, including eyelashes.

Courtesy Dr. Maria Hicks and Dr. Donna Bilu Martin

Pruritus can be severe. Secondary bacterial infections may occur as maculae ceruleae, or blue-colored macules, on the skin. The lice are visible to the naked eye and are approximately 1 mm in length. They have a crablike appearance, six legs, and a wide body. Nits may be present on the hair shaft. Unlike hair casts, which can be moved up and down along the hair shaft, nits firmly adhere to the hair. Diagnosis should prompt a workup for other sexually transmitted diseases, including HIV.

Treatment for patients and their sexual partners include permethrin topically; and laundering of clothing and bedding. Lice on the eyelashes can be treated with 8 days of twice-daily applications of petrolatum. Ivermectin can be used when topical therapy fails, although this is an off-label treatment (not approved by the Food and Drug Administration).

Pediculosis corporis – body lice or clothing lice – is also known as “vagabond’s disease” and is caused by Pediculus humanus var corporis. Body lice lay their eggs in clothing seams and can live in clothing for up to 1 month without feeding on human blood. Often homeless individuals and those living in overcrowded areas can be affected. The louse and nits also are visible to the naked eye. They have a longer, narrower body than Phthirus pubis and are more similar in appearance to head lice. They rarely are found on the skin.

Body lice may carry disease such as epidemic typhus, relapsing fever, and trench fever or endocarditis. Permethrin is the most widely used treatment to kill both lice and ova. Other treatments include Malathion, Lindane, and Crotamiton. Clothing and bedding should be laundered.

Scabies is a mite infestation caused by Sarcoptes scabiei. Unlike lice, scabies often affects the hands and feet. Characteristic linear burrows may be seen in the finger web spaces. The circle of Hebra describes the areas commonly infected by mites: axillae, antecubital fossa, wrists, hands, and the groin. Pruritus may be severe and worse at night. Patients may be afflicted with both lice and scabies at the same time. Mites are not visible to the naked eye but can be seen microscopically. Topical permethrin cream is used most often for treatment. All household contacts should be treated at the same time. As in louse infestations, clothing and bedding should be laundered. Ivermectin can be used for crusted scabies, although this is an off-label treatment.

This case and photo were submitted by Maria Hicks, MD, Advanced Dermatology and Cosmetic Surgery, Tampa, and Dr. Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].

Pediculosis pubis, also known as pubic lice, or “crabs,” is an infestation of Phthirus pubis. Crab lice are spread sexually and through close skin contact, as well as contaminated clothes and bedding. Adult lice can live up to 36 hours away from its host. Pubic areas most commonly are affected, although other hair-bearing parts of the body often are affected, including eyelashes.

Courtesy Dr. Maria Hicks and Dr. Donna Bilu Martin

Pruritus can be severe. Secondary bacterial infections may occur as maculae ceruleae, or blue-colored macules, on the skin. The lice are visible to the naked eye and are approximately 1 mm in length. They have a crablike appearance, six legs, and a wide body. Nits may be present on the hair shaft. Unlike hair casts, which can be moved up and down along the hair shaft, nits firmly adhere to the hair. Diagnosis should prompt a workup for other sexually transmitted diseases, including HIV.

Treatment for patients and their sexual partners include permethrin topically; and laundering of clothing and bedding. Lice on the eyelashes can be treated with 8 days of twice-daily applications of petrolatum. Ivermectin can be used when topical therapy fails, although this is an off-label treatment (not approved by the Food and Drug Administration).

Pediculosis corporis – body lice or clothing lice – is also known as “vagabond’s disease” and is caused by Pediculus humanus var corporis. Body lice lay their eggs in clothing seams and can live in clothing for up to 1 month without feeding on human blood. Often homeless individuals and those living in overcrowded areas can be affected. The louse and nits also are visible to the naked eye. They have a longer, narrower body than Phthirus pubis and are more similar in appearance to head lice. They rarely are found on the skin.

Body lice may carry disease such as epidemic typhus, relapsing fever, and trench fever or endocarditis. Permethrin is the most widely used treatment to kill both lice and ova. Other treatments include Malathion, Lindane, and Crotamiton. Clothing and bedding should be laundered.

Scabies is a mite infestation caused by Sarcoptes scabiei. Unlike lice, scabies often affects the hands and feet. Characteristic linear burrows may be seen in the finger web spaces. The circle of Hebra describes the areas commonly infected by mites: axillae, antecubital fossa, wrists, hands, and the groin. Pruritus may be severe and worse at night. Patients may be afflicted with both lice and scabies at the same time. Mites are not visible to the naked eye but can be seen microscopically. Topical permethrin cream is used most often for treatment. All household contacts should be treated at the same time. As in louse infestations, clothing and bedding should be laundered. Ivermectin can be used for crusted scabies, although this is an off-label treatment.

This case and photo were submitted by Maria Hicks, MD, Advanced Dermatology and Cosmetic Surgery, Tampa, and Dr. Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].

Pediculosis pubis, also known as pubic lice, or “crabs,” is an infestation of Phthirus pubis. Crab lice are spread sexually and through close skin contact, as well as contaminated clothes and bedding. Adult lice can live up to 36 hours away from its host. Pubic areas most commonly are affected, although other hair-bearing parts of the body often are affected, including eyelashes.

Courtesy Dr. Maria Hicks and Dr. Donna Bilu Martin

Pruritus can be severe. Secondary bacterial infections may occur as maculae ceruleae, or blue-colored macules, on the skin. The lice are visible to the naked eye and are approximately 1 mm in length. They have a crablike appearance, six legs, and a wide body. Nits may be present on the hair shaft. Unlike hair casts, which can be moved up and down along the hair shaft, nits firmly adhere to the hair. Diagnosis should prompt a workup for other sexually transmitted diseases, including HIV.

Treatment for patients and their sexual partners include permethrin topically; and laundering of clothing and bedding. Lice on the eyelashes can be treated with 8 days of twice-daily applications of petrolatum. Ivermectin can be used when topical therapy fails, although this is an off-label treatment (not approved by the Food and Drug Administration).

Pediculosis corporis – body lice or clothing lice – is also known as “vagabond’s disease” and is caused by Pediculus humanus var corporis. Body lice lay their eggs in clothing seams and can live in clothing for up to 1 month without feeding on human blood. Often homeless individuals and those living in overcrowded areas can be affected. The louse and nits also are visible to the naked eye. They have a longer, narrower body than Phthirus pubis and are more similar in appearance to head lice. They rarely are found on the skin.

Body lice may carry disease such as epidemic typhus, relapsing fever, and trench fever or endocarditis. Permethrin is the most widely used treatment to kill both lice and ova. Other treatments include Malathion, Lindane, and Crotamiton. Clothing and bedding should be laundered.

Scabies is a mite infestation caused by Sarcoptes scabiei. Unlike lice, scabies often affects the hands and feet. Characteristic linear burrows may be seen in the finger web spaces. The circle of Hebra describes the areas commonly infected by mites: axillae, antecubital fossa, wrists, hands, and the groin. Pruritus may be severe and worse at night. Patients may be afflicted with both lice and scabies at the same time. Mites are not visible to the naked eye but can be seen microscopically. Topical permethrin cream is used most often for treatment. All household contacts should be treated at the same time. As in louse infestations, clothing and bedding should be laundered. Ivermectin can be used for crusted scabies, although this is an off-label treatment.

This case and photo were submitted by Maria Hicks, MD, Advanced Dermatology and Cosmetic Surgery, Tampa, and Dr. Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].

AUSTIN, TEX. – Taking a page from critical care, an obstetrical team that implemented a checklist-based management protocol for postpartum hemorrhage saw a significant drop in severe obstetric hemorrhage, with numeric reductions in other maternal outcomes.

The protocol, piloted in a single hospital, is now being rolled out in all 28 hospitals of a large, multistate health care system.

“Our medical critical care colleagues long ago abandoned the notion that physician judgment should guide the provision of basic and advanced cardiac life support in favor of highly specific and uniform protocols,” wrote first author Rachael Smith, DO, and her coauthors in the poster accompanying the presentation at the annual clinical and scientific meeting of the American Society of Obstetricians and Gynecologists.

“While existing guidelines outlining a general approach to postpartum hemorrhage are useful, recent data suggest that greater specificity is necessary to significantly impact morbidity and mortality,” they wrote.

When comparing outcomes for 9 matched months before and after implementation of the protocol, Dr. Smith and her collaborators found that rates of severe postpartum hemorrhage (PPH), defined as estimated blood loss (EBL) of at least 2,500 cc, were halved, dropping from 18% to 9% (P = .035).

Kari Oakes

[email protected]

SOURCE: Smith R et al. ACOG 2018, Abstract 26R.

AUSTIN, TEX. – Taking a page from critical care, an obstetrical team that implemented a checklist-based management protocol for postpartum hemorrhage saw a significant drop in severe obstetric hemorrhage, with numeric reductions in other maternal outcomes.

The protocol, piloted in a single hospital, is now being rolled out in all 28 hospitals of a large, multistate health care system.

“Our medical critical care colleagues long ago abandoned the notion that physician judgment should guide the provision of basic and advanced cardiac life support in favor of highly specific and uniform protocols,” wrote first author Rachael Smith, DO, and her coauthors in the poster accompanying the presentation at the annual clinical and scientific meeting of the American Society of Obstetricians and Gynecologists.

“While existing guidelines outlining a general approach to postpartum hemorrhage are useful, recent data suggest that greater specificity is necessary to significantly impact morbidity and mortality,” they wrote.

When comparing outcomes for 9 matched months before and after implementation of the protocol, Dr. Smith and her collaborators found that rates of severe postpartum hemorrhage (PPH), defined as estimated blood loss (EBL) of at least 2,500 cc, were halved, dropping from 18% to 9% (P = .035).

Kari Oakes

[email protected]

SOURCE: Smith R et al. ACOG 2018, Abstract 26R.

AUSTIN, TEX. – Taking a page from critical care, an obstetrical team that implemented a checklist-based management protocol for postpartum hemorrhage saw a significant drop in severe obstetric hemorrhage, with numeric reductions in other maternal outcomes.

The protocol, piloted in a single hospital, is now being rolled out in all 28 hospitals of a large, multistate health care system.

“Our medical critical care colleagues long ago abandoned the notion that physician judgment should guide the provision of basic and advanced cardiac life support in favor of highly specific and uniform protocols,” wrote first author Rachael Smith, DO, and her coauthors in the poster accompanying the presentation at the annual clinical and scientific meeting of the American Society of Obstetricians and Gynecologists.

“While existing guidelines outlining a general approach to postpartum hemorrhage are useful, recent data suggest that greater specificity is necessary to significantly impact morbidity and mortality,” they wrote.

When comparing outcomes for 9 matched months before and after implementation of the protocol, Dr. Smith and her collaborators found that rates of severe postpartum hemorrhage (PPH), defined as estimated blood loss (EBL) of at least 2,500 cc, were halved, dropping from 18% to 9% (P = .035).

Kari Oakes

[email protected]

SOURCE: Smith R et al. ACOG 2018, Abstract 26R.

PITTSBURGH – In the current era, children with Down syndrome who have standard risk B-cell precursor acute lymphoblastic leukemia have event-free and overall survival rates nearly as good as those of other children with standard-risk B–ALL, results of a Children’s Oncology Group study show.

Among 5,311 children enrolled in the COG AALL0331 trial, a study of combination chemotherapy for young patients with newly diagnosed ALL, the 5-year event-free survival (EFS) rate for children with Down syndrome was 86%, compared with 89% for children without Down syndrome (P = .025).

Neil Osterweil/MDedge News

At the end of induction, patients who were judged to be standard-risk average were then randomized in a 2x2 design to either standard or intensified consolidation, and to standard interim maintenance with delayed intensification, or to intensified interim maintenance with delayed intensification.

The intensified interim maintenance with delayed intensification randomization was closed in 2008 because of superior results with escalating intravenous methotrexate during interim maintenance for standard-risk ALL patients treated in the CCG 1991 trial. Subsequently, all patients enrolled in AALL0331 received escalating intravenous methotrexate during interim maintenance.

Also in AALL0331, patients with Down syndrome who had standard-high ALL were given intensified consolidation and a single vs. double intensified interim maintenance with delayed intensification; patients without Down syndrome and standard risk high received the double intensified interim maintenance regimen.

Standard-risk low Down syndrome patients and non–Down syndrome patients participated in a randomization to additional pegaspargase doses during consolidation and interim maintenance.

There were no significant differences between patients with or without Down syndrome in the proportion of either rapid or slow early responses. Significantly fewer patients with Down syndrome had standard-risk low disease, and significantly more had average or high-risk disease.

Patients with Down syndrome initially had 11.5% excess risk for death during induction, but following additional treatment modifications, the excess risk decreased to 1.7%.

Among patients with Down syndrome, one died during intensive consolidation, and two died during delayed intensification. All three deaths were due to infections. No patients with Down syndrome died during maintenance.

Patients with Down syndrome also had a significantly increased risk for infection during induction (P less than .0001).

For patients with standard-risk low disease, 5-year EFS was 100% for those with Down syndrome, compared with 95.35% for patients without. Respective rates for standard risk average and high disease were 88.07% vs. 89.63%. and 82.35% vs. 86.18%.

Down syndrome was not an independent risk factor for survival in multivariate analyses accounting for risk group, Dr. Maloney said.

COG AALL0331 was supported by the National Cancer Institute. Dr. Maloney reported having no financial disclosures.

SOURCE: Maloney K et al. ASPHO 2018, Abstract PP 2001.

PITTSBURGH – In the current era, children with Down syndrome who have standard risk B-cell precursor acute lymphoblastic leukemia have event-free and overall survival rates nearly as good as those of other children with standard-risk B–ALL, results of a Children’s Oncology Group study show.

Among 5,311 children enrolled in the COG AALL0331 trial, a study of combination chemotherapy for young patients with newly diagnosed ALL, the 5-year event-free survival (EFS) rate for children with Down syndrome was 86%, compared with 89% for children without Down syndrome (P = .025).

Neil Osterweil/MDedge News

At the end of induction, patients who were judged to be standard-risk average were then randomized in a 2x2 design to either standard or intensified consolidation, and to standard interim maintenance with delayed intensification, or to intensified interim maintenance with delayed intensification.

The intensified interim maintenance with delayed intensification randomization was closed in 2008 because of superior results with escalating intravenous methotrexate during interim maintenance for standard-risk ALL patients treated in the CCG 1991 trial. Subsequently, all patients enrolled in AALL0331 received escalating intravenous methotrexate during interim maintenance.

Also in AALL0331, patients with Down syndrome who had standard-high ALL were given intensified consolidation and a single vs. double intensified interim maintenance with delayed intensification; patients without Down syndrome and standard risk high received the double intensified interim maintenance regimen.

Standard-risk low Down syndrome patients and non–Down syndrome patients participated in a randomization to additional pegaspargase doses during consolidation and interim maintenance.

There were no significant differences between patients with or without Down syndrome in the proportion of either rapid or slow early responses. Significantly fewer patients with Down syndrome had standard-risk low disease, and significantly more had average or high-risk disease.

Patients with Down syndrome initially had 11.5% excess risk for death during induction, but following additional treatment modifications, the excess risk decreased to 1.7%.

Among patients with Down syndrome, one died during intensive consolidation, and two died during delayed intensification. All three deaths were due to infections. No patients with Down syndrome died during maintenance.

Patients with Down syndrome also had a significantly increased risk for infection during induction (P less than .0001).

For patients with standard-risk low disease, 5-year EFS was 100% for those with Down syndrome, compared with 95.35% for patients without. Respective rates for standard risk average and high disease were 88.07% vs. 89.63%. and 82.35% vs. 86.18%.

Down syndrome was not an independent risk factor for survival in multivariate analyses accounting for risk group, Dr. Maloney said.

COG AALL0331 was supported by the National Cancer Institute. Dr. Maloney reported having no financial disclosures.

SOURCE: Maloney K et al. ASPHO 2018, Abstract PP 2001.

PITTSBURGH – In the current era, children with Down syndrome who have standard risk B-cell precursor acute lymphoblastic leukemia have event-free and overall survival rates nearly as good as those of other children with standard-risk B–ALL, results of a Children’s Oncology Group study show.

Among 5,311 children enrolled in the COG AALL0331 trial, a study of combination chemotherapy for young patients with newly diagnosed ALL, the 5-year event-free survival (EFS) rate for children with Down syndrome was 86%, compared with 89% for children without Down syndrome (P = .025).

Neil Osterweil/MDedge News

At the end of induction, patients who were judged to be standard-risk average were then randomized in a 2x2 design to either standard or intensified consolidation, and to standard interim maintenance with delayed intensification, or to intensified interim maintenance with delayed intensification.

The intensified interim maintenance with delayed intensification randomization was closed in 2008 because of superior results with escalating intravenous methotrexate during interim maintenance for standard-risk ALL patients treated in the CCG 1991 trial. Subsequently, all patients enrolled in AALL0331 received escalating intravenous methotrexate during interim maintenance.

Also in AALL0331, patients with Down syndrome who had standard-high ALL were given intensified consolidation and a single vs. double intensified interim maintenance with delayed intensification; patients without Down syndrome and standard risk high received the double intensified interim maintenance regimen.

Standard-risk low Down syndrome patients and non–Down syndrome patients participated in a randomization to additional pegaspargase doses during consolidation and interim maintenance.

There were no significant differences between patients with or without Down syndrome in the proportion of either rapid or slow early responses. Significantly fewer patients with Down syndrome had standard-risk low disease, and significantly more had average or high-risk disease.

Patients with Down syndrome initially had 11.5% excess risk for death during induction, but following additional treatment modifications, the excess risk decreased to 1.7%.

Among patients with Down syndrome, one died during intensive consolidation, and two died during delayed intensification. All three deaths were due to infections. No patients with Down syndrome died during maintenance.

Patients with Down syndrome also had a significantly increased risk for infection during induction (P less than .0001).

For patients with standard-risk low disease, 5-year EFS was 100% for those with Down syndrome, compared with 95.35% for patients without. Respective rates for standard risk average and high disease were 88.07% vs. 89.63%. and 82.35% vs. 86.18%.

Down syndrome was not an independent risk factor for survival in multivariate analyses accounting for risk group, Dr. Maloney said.

COG AALL0331 was supported by the National Cancer Institute. Dr. Maloney reported having no financial disclosures.

SOURCE: Maloney K et al. ASPHO 2018, Abstract PP 2001.

LOS ANGELES—Most older adults recover well from traumatic brain injury (TBI), according to research presented at the 70th Annual Meeting of the American Academy of Neurology. Compared with younger patients, older adults endorse less independence after injury, but are less likely to report TBI-related neurobehavioral symptoms. A greater burden of preinjury disability among the elderly may explain these apparently conflicting results, according to the researchers.

Geriatric TBI is “a silent and growing epidemic,” said Raquel Gardner, MD, Assistant Professor of Neurology at the University of California, San Francisco. Older adults have the highest incidence of TBI-related emergency department visits, hospitalizations, and deaths, according to 2013 data from the CDC. Most research has indicated that this population has worse outcomes of TBI than younger populations do. Few studies, however, have examined age-related differences in neurobehavioral outcomes of TBI.

Injury Was More Severe Among Older Patients

To address this gap in the literature, Dr. Gardner and colleagues examined data from the TRACK-TBI pilot study. Eligible patients presented to participating trauma centers within 24 hours of sustaining a TBI that was severe enough to warrant head CT. The TRACK-TBI study excluded participants with a diagnosis of dementia or any pre-existing condition that would impair their ability to complete outcome assessments. Patients’ neurobehavioral outcomes were evaluated prospectively with measures such as the Glasgow Outcome Scale Extended (GOSE), Craig Handicap Assessment and Reporting Technique-Short Form (CHART-SF), Brief Symptom Inventory (BSI-18), Rivermead Post-Concussion Questionnaire (RPQ), Posttraumatic Stress Disorder Checklist-Civilian (PCL-C), and the Satisfaction With Life Scale (SWLS).

Dr. Gardner and colleagues categorized 586 patients as young (ie, younger than 40), middle-aged (ie, ages 40 to 59), or older (ie, age 60 or older). They compared baseline features and six-month neurobehavioral outcomes between the three groups using χ2, analysis of variance, and regression modeling.

Patients’ age ranged from 16 to 94. At baseline, the prevalence of female sex and white race increased with increasing age. Older adults were less likely to report a prior history of TBI than the other two age groups. TBI resulted from a fall for most older patients. At presentation, Glasgow Coma Scale scores did not differ significantly between the three patient groups, and older adults were less likely to report having experienced loss of consciousness or posttraumatic amnesia than the other groups.

Injury was more severe among older patients, however, as assessed by the Acute Injury Scale, the Injury Severity Scale, and CT pathology, compared with younger participants. Older patients also were more likely to be admitted to the intensive care unit.

Measures May Not Be Age-Appropriate

At six months, 415 of the participants completed the GOSE. The mortality rate was approximately 18% among older patients, compared with 7% among middle-aged patients and less than 1% among young patients. Among older patients who survived to six months, most achieved a good recovery, which was defined as a GOSE score of 7 to 8. After the researchers adjusted the data for baseline demographic differences, the rate of good recovery was not significantly different between the three age groups.

Older patients reported significantly less anxiety than other patients, as measured by the BSI-18. Older patients tended to report fewer symptoms overall on the BSI-18 and the RPQ, compared with the other groups. In addition, older patients reported fewer symptoms of PTSD and less dissatisfaction with life, compared with the other groups.

CHART-SF scores, however, were worse overall among older patients, said Dr. Gardner. Although they indicated better economic outcomes among older patients, compared with the other age groups, they also indicated less independence among older patients. Cognition and mobility in particular were worse among older patients than among the other groups.

Older patients were more likely to complete the GOSE than younger patients, but less likely to complete other assessments. The differences in response rates could create a misleadingly positive impression of six-month outcomes among older patients, said Dr. Gardner.

One interpretation of the results is that measures that are not age-appropriate are causing older patients to underreport TBI symptoms, she added. Survival bias also may partly explain the positive six-month outcomes. “We need studies that are truly representative of the entire geriatric TBI population and systematically measure, rather than exclude for, this huge heterogeneity in preinjury disability,” said Dr. Gardner. Investigators should take steps “to optimize enrollment, optimize retention, and optimize outcome completion in a frail and burdened population. We need to ultimately develop consensus NINDS geriatric TBI common data elements…. Only then can we unravel predictors of meaningful recovery in this vulnerable population, develop age-appropriate treatment guidelines, and improve outcomes.”

—Erik Greb

Suggested Reading

Yue JK, Winkler EA, Sharma S, et al. Temporal profile of care following mild traumatic brain injury: predictors of hospital admission, follow-up referral and six-month outcome. Brain Inj. 2017;31(13-14):1820-1829.

LOS ANGELES—Most older adults recover well from traumatic brain injury (TBI), according to research presented at the 70th Annual Meeting of the American Academy of Neurology. Compared with younger patients, older adults endorse less independence after injury, but are less likely to report TBI-related neurobehavioral symptoms. A greater burden of preinjury disability among the elderly may explain these apparently conflicting results, according to the researchers.

Geriatric TBI is “a silent and growing epidemic,” said Raquel Gardner, MD, Assistant Professor of Neurology at the University of California, San Francisco. Older adults have the highest incidence of TBI-related emergency department visits, hospitalizations, and deaths, according to 2013 data from the CDC. Most research has indicated that this population has worse outcomes of TBI than younger populations do. Few studies, however, have examined age-related differences in neurobehavioral outcomes of TBI.

Injury Was More Severe Among Older Patients

To address this gap in the literature, Dr. Gardner and colleagues examined data from the TRACK-TBI pilot study. Eligible patients presented to participating trauma centers within 24 hours of sustaining a TBI that was severe enough to warrant head CT. The TRACK-TBI study excluded participants with a diagnosis of dementia or any pre-existing condition that would impair their ability to complete outcome assessments. Patients’ neurobehavioral outcomes were evaluated prospectively with measures such as the Glasgow Outcome Scale Extended (GOSE), Craig Handicap Assessment and Reporting Technique-Short Form (CHART-SF), Brief Symptom Inventory (BSI-18), Rivermead Post-Concussion Questionnaire (RPQ), Posttraumatic Stress Disorder Checklist-Civilian (PCL-C), and the Satisfaction With Life Scale (SWLS).

Dr. Gardner and colleagues categorized 586 patients as young (ie, younger than 40), middle-aged (ie, ages 40 to 59), or older (ie, age 60 or older). They compared baseline features and six-month neurobehavioral outcomes between the three groups using χ2, analysis of variance, and regression modeling.

Patients’ age ranged from 16 to 94. At baseline, the prevalence of female sex and white race increased with increasing age. Older adults were less likely to report a prior history of TBI than the other two age groups. TBI resulted from a fall for most older patients. At presentation, Glasgow Coma Scale scores did not differ significantly between the three patient groups, and older adults were less likely to report having experienced loss of consciousness or posttraumatic amnesia than the other groups.

Injury was more severe among older patients, however, as assessed by the Acute Injury Scale, the Injury Severity Scale, and CT pathology, compared with younger participants. Older patients also were more likely to be admitted to the intensive care unit.

Measures May Not Be Age-Appropriate

At six months, 415 of the participants completed the GOSE. The mortality rate was approximately 18% among older patients, compared with 7% among middle-aged patients and less than 1% among young patients. Among older patients who survived to six months, most achieved a good recovery, which was defined as a GOSE score of 7 to 8. After the researchers adjusted the data for baseline demographic differences, the rate of good recovery was not significantly different between the three age groups.

Older patients reported significantly less anxiety than other patients, as measured by the BSI-18. Older patients tended to report fewer symptoms overall on the BSI-18 and the RPQ, compared with the other groups. In addition, older patients reported fewer symptoms of PTSD and less dissatisfaction with life, compared with the other groups.

CHART-SF scores, however, were worse overall among older patients, said Dr. Gardner. Although they indicated better economic outcomes among older patients, compared with the other age groups, they also indicated less independence among older patients. Cognition and mobility in particular were worse among older patients than among the other groups.

Older patients were more likely to complete the GOSE than younger patients, but less likely to complete other assessments. The differences in response rates could create a misleadingly positive impression of six-month outcomes among older patients, said Dr. Gardner.

One interpretation of the results is that measures that are not age-appropriate are causing older patients to underreport TBI symptoms, she added. Survival bias also may partly explain the positive six-month outcomes. “We need studies that are truly representative of the entire geriatric TBI population and systematically measure, rather than exclude for, this huge heterogeneity in preinjury disability,” said Dr. Gardner. Investigators should take steps “to optimize enrollment, optimize retention, and optimize outcome completion in a frail and burdened population. We need to ultimately develop consensus NINDS geriatric TBI common data elements…. Only then can we unravel predictors of meaningful recovery in this vulnerable population, develop age-appropriate treatment guidelines, and improve outcomes.”

—Erik Greb

Suggested Reading

Yue JK, Winkler EA, Sharma S, et al. Temporal profile of care following mild traumatic brain injury: predictors of hospital admission, follow-up referral and six-month outcome. Brain Inj. 2017;31(13-14):1820-1829.

LOS ANGELES—Most older adults recover well from traumatic brain injury (TBI), according to research presented at the 70th Annual Meeting of the American Academy of Neurology. Compared with younger patients, older adults endorse less independence after injury, but are less likely to report TBI-related neurobehavioral symptoms. A greater burden of preinjury disability among the elderly may explain these apparently conflicting results, according to the researchers.

Geriatric TBI is “a silent and growing epidemic,” said Raquel Gardner, MD, Assistant Professor of Neurology at the University of California, San Francisco. Older adults have the highest incidence of TBI-related emergency department visits, hospitalizations, and deaths, according to 2013 data from the CDC. Most research has indicated that this population has worse outcomes of TBI than younger populations do. Few studies, however, have examined age-related differences in neurobehavioral outcomes of TBI.

Injury Was More Severe Among Older Patients

To address this gap in the literature, Dr. Gardner and colleagues examined data from the TRACK-TBI pilot study. Eligible patients presented to participating trauma centers within 24 hours of sustaining a TBI that was severe enough to warrant head CT. The TRACK-TBI study excluded participants with a diagnosis of dementia or any pre-existing condition that would impair their ability to complete outcome assessments. Patients’ neurobehavioral outcomes were evaluated prospectively with measures such as the Glasgow Outcome Scale Extended (GOSE), Craig Handicap Assessment and Reporting Technique-Short Form (CHART-SF), Brief Symptom Inventory (BSI-18), Rivermead Post-Concussion Questionnaire (RPQ), Posttraumatic Stress Disorder Checklist-Civilian (PCL-C), and the Satisfaction With Life Scale (SWLS).

Dr. Gardner and colleagues categorized 586 patients as young (ie, younger than 40), middle-aged (ie, ages 40 to 59), or older (ie, age 60 or older). They compared baseline features and six-month neurobehavioral outcomes between the three groups using χ2, analysis of variance, and regression modeling.

Patients’ age ranged from 16 to 94. At baseline, the prevalence of female sex and white race increased with increasing age. Older adults were less likely to report a prior history of TBI than the other two age groups. TBI resulted from a fall for most older patients. At presentation, Glasgow Coma Scale scores did not differ significantly between the three patient groups, and older adults were less likely to report having experienced loss of consciousness or posttraumatic amnesia than the other groups.

Injury was more severe among older patients, however, as assessed by the Acute Injury Scale, the Injury Severity Scale, and CT pathology, compared with younger participants. Older patients also were more likely to be admitted to the intensive care unit.

Measures May Not Be Age-Appropriate

At six months, 415 of the participants completed the GOSE. The mortality rate was approximately 18% among older patients, compared with 7% among middle-aged patients and less than 1% among young patients. Among older patients who survived to six months, most achieved a good recovery, which was defined as a GOSE score of 7 to 8. After the researchers adjusted the data for baseline demographic differences, the rate of good recovery was not significantly different between the three age groups.

Older patients reported significantly less anxiety than other patients, as measured by the BSI-18. Older patients tended to report fewer symptoms overall on the BSI-18 and the RPQ, compared with the other groups. In addition, older patients reported fewer symptoms of PTSD and less dissatisfaction with life, compared with the other groups.

CHART-SF scores, however, were worse overall among older patients, said Dr. Gardner. Although they indicated better economic outcomes among older patients, compared with the other age groups, they also indicated less independence among older patients. Cognition and mobility in particular were worse among older patients than among the other groups.

Older patients were more likely to complete the GOSE than younger patients, but less likely to complete other assessments. The differences in response rates could create a misleadingly positive impression of six-month outcomes among older patients, said Dr. Gardner.

One interpretation of the results is that measures that are not age-appropriate are causing older patients to underreport TBI symptoms, she added. Survival bias also may partly explain the positive six-month outcomes. “We need studies that are truly representative of the entire geriatric TBI population and systematically measure, rather than exclude for, this huge heterogeneity in preinjury disability,” said Dr. Gardner. Investigators should take steps “to optimize enrollment, optimize retention, and optimize outcome completion in a frail and burdened population. We need to ultimately develop consensus NINDS geriatric TBI common data elements…. Only then can we unravel predictors of meaningful recovery in this vulnerable population, develop age-appropriate treatment guidelines, and improve outcomes.”

—Erik Greb

Suggested Reading

Yue JK, Winkler EA, Sharma S, et al. Temporal profile of care following mild traumatic brain injury: predictors of hospital admission, follow-up referral and six-month outcome. Brain Inj. 2017;31(13-14):1820-1829.

By now, you are probably aware that the Centers for Medicare and Medicaid Services has begun the process of switching out old Medicare cards (and numbers) for new ones. The new, completely random number-letter combinations – dubbed Medicare Beneficiary Identifiers (MBI) – replace the old Social Security number–based Health Insurance Claim Numbers (HICN). The idea is to make citizens’ private information less vulnerable to identity thieves and other nefarious parties.

The switch began on April 1, and is expected to take about a year as the CMS processes about half a dozen states at a time. As I write this (at the beginning of May), the CMS is mailing out the first group of new cards to patients in Pennsylvania, Virginia, West Virginia, Maryland, Delaware, and the District of Columbia. But regardless of where you practice, you can expect to start seeing MBIs in your office soon – if you haven’t already – because people enrolling in Medicare for the first time are also receiving the new cards, no matter where they live.

Unlike the abrupt switch in 2015 from ICD-9 coding to ICD-10, this changeover has a transition period: Both HICNs and MBIs can be used on all billing and Medicare transactions from now until the end of 2019; after that, only claims with MBIs will be accepted. The last day of 2019 may sound like a long way off, but the time to get up to speed on everything MBI is now. That way, you can begin processing MBIs as soon as you start receiving them, and you will have time to solve any processing glitches well before the deadline.

First, you’ll need to make sure that your electronic health records and claims processing software will accept the new format, and that your electronic clearinghouse, if you use one, is geared up to accept and transmit the data on the new cards. Not all of them are. Some have been seduced by the year-and-a-half buffer – during which time HICNs can still be used – into dragging their feet on the MBI issue. Now is the time to find out if a vendor’s software is hard-wired to accept a maximum of 10 digits (MBIs have 11), not when your claims start bouncing.

Second, you will need to educate your front desk staff, so they will be able to recognize the new cards at a glance. Unfortunately, it looks a lot like the current card, though it is slightly smaller. It has the traditional red and blue colors with black printing, but there is no birthday or gender designation – again, in the interest of protecting patients’ identities. Knowing the difference will become particularly important after your state has been processed, when all of your Medicare patients should have the new card. Those who don’t will need to be identified and urged to get one before the December 2019 deadline.

Centers for Medicare & Medicaid Services

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

By now, you are probably aware that the Centers for Medicare and Medicaid Services has begun the process of switching out old Medicare cards (and numbers) for new ones. The new, completely random number-letter combinations – dubbed Medicare Beneficiary Identifiers (MBI) – replace the old Social Security number–based Health Insurance Claim Numbers (HICN). The idea is to make citizens’ private information less vulnerable to identity thieves and other nefarious parties.

The switch began on April 1, and is expected to take about a year as the CMS processes about half a dozen states at a time. As I write this (at the beginning of May), the CMS is mailing out the first group of new cards to patients in Pennsylvania, Virginia, West Virginia, Maryland, Delaware, and the District of Columbia. But regardless of where you practice, you can expect to start seeing MBIs in your office soon – if you haven’t already – because people enrolling in Medicare for the first time are also receiving the new cards, no matter where they live.

Unlike the abrupt switch in 2015 from ICD-9 coding to ICD-10, this changeover has a transition period: Both HICNs and MBIs can be used on all billing and Medicare transactions from now until the end of 2019; after that, only claims with MBIs will be accepted. The last day of 2019 may sound like a long way off, but the time to get up to speed on everything MBI is now. That way, you can begin processing MBIs as soon as you start receiving them, and you will have time to solve any processing glitches well before the deadline.

First, you’ll need to make sure that your electronic health records and claims processing software will accept the new format, and that your electronic clearinghouse, if you use one, is geared up to accept and transmit the data on the new cards. Not all of them are. Some have been seduced by the year-and-a-half buffer – during which time HICNs can still be used – into dragging their feet on the MBI issue. Now is the time to find out if a vendor’s software is hard-wired to accept a maximum of 10 digits (MBIs have 11), not when your claims start bouncing.

Second, you will need to educate your front desk staff, so they will be able to recognize the new cards at a glance. Unfortunately, it looks a lot like the current card, though it is slightly smaller. It has the traditional red and blue colors with black printing, but there is no birthday or gender designation – again, in the interest of protecting patients’ identities. Knowing the difference will become particularly important after your state has been processed, when all of your Medicare patients should have the new card. Those who don’t will need to be identified and urged to get one before the December 2019 deadline.

Centers for Medicare & Medicaid Services

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

By now, you are probably aware that the Centers for Medicare and Medicaid Services has begun the process of switching out old Medicare cards (and numbers) for new ones. The new, completely random number-letter combinations – dubbed Medicare Beneficiary Identifiers (MBI) – replace the old Social Security number–based Health Insurance Claim Numbers (HICN). The idea is to make citizens’ private information less vulnerable to identity thieves and other nefarious parties.

The switch began on April 1, and is expected to take about a year as the CMS processes about half a dozen states at a time. As I write this (at the beginning of May), the CMS is mailing out the first group of new cards to patients in Pennsylvania, Virginia, West Virginia, Maryland, Delaware, and the District of Columbia. But regardless of where you practice, you can expect to start seeing MBIs in your office soon – if you haven’t already – because people enrolling in Medicare for the first time are also receiving the new cards, no matter where they live.

Unlike the abrupt switch in 2015 from ICD-9 coding to ICD-10, this changeover has a transition period: Both HICNs and MBIs can be used on all billing and Medicare transactions from now until the end of 2019; after that, only claims with MBIs will be accepted. The last day of 2019 may sound like a long way off, but the time to get up to speed on everything MBI is now. That way, you can begin processing MBIs as soon as you start receiving them, and you will have time to solve any processing glitches well before the deadline.

First, you’ll need to make sure that your electronic health records and claims processing software will accept the new format, and that your electronic clearinghouse, if you use one, is geared up to accept and transmit the data on the new cards. Not all of them are. Some have been seduced by the year-and-a-half buffer – during which time HICNs can still be used – into dragging their feet on the MBI issue. Now is the time to find out if a vendor’s software is hard-wired to accept a maximum of 10 digits (MBIs have 11), not when your claims start bouncing.

Second, you will need to educate your front desk staff, so they will be able to recognize the new cards at a glance. Unfortunately, it looks a lot like the current card, though it is slightly smaller. It has the traditional red and blue colors with black printing, but there is no birthday or gender designation – again, in the interest of protecting patients’ identities. Knowing the difference will become particularly important after your state has been processed, when all of your Medicare patients should have the new card. Those who don’t will need to be identified and urged to get one before the December 2019 deadline.

Centers for Medicare & Medicaid Services

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

BOSTON – Results from the CABANA trial, the long-awaited, head-to-head comparison of percutaneous catheter ablation with drug therapy for the treatment of atrial fibrillation by restoring sinus rhythm, failed to accomplish what it was designed to prove.

That is, that catheter ablation was superior to medical management for a combined endpoint of all-cause death, stroke, serious bleeding, or cardiac arrest.

Mitchel L. Zoler/MDedge News

The dilemma that Dr. Ruskin and other physicians who heard the results voiced was how best to interpret the study’s primary results.

“This trial was designed to address whether ablation has an impact [compared with medical management] on hard endpoints, like mortality, and the intention-to-treat analysis showed no difference. I feel bound to adhere to the intention-to-treat analysis, the primary result” the traditional default arbiter of a randomized trial’s outcome, Dr. Ruskin said in an interview, “But intention-to-treat analyses are built on a foundation where most patients are maintained on their assigned treatment.”

Mitchel L. Zoler/MDedge News

“There was certainly no signal whatsoever of harm by taking patients to ablation early” in their management, agreed Dr. Ruskin. “I find that very reassuring and encouraging.”

CABANA (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial) started in 2009 and enrolled 2,204 patients with documented, new-onset paroxysmal or persistent atrial fibrillation (AF) at 110 centers in 10 countries. Patients averaged about 68 years of age, with about 15% at least 75 years old, and in general were what Dr. Packer characterized as a high-risk group, with a high prevalence of comorbidities: 23% with sleep apnea, 10% with cardiomyopathy, 15% with heart failure, 10% with a prior stroke or transient ischemic attack, and just over a third in a New York Heart Association functional class II or III. About 43% had paroxysmal AF, about 47% had persistent AF, and the remaining patients had long-standing persistent AF. The median duration of AF at the time of entry was just over 1 year.

The clinicians treating the patients assigned to medical management could decide on a case-by-case basis whether to use rate or rhythm control, and about 12% of patients received rate control. The trial design specified pulmonary-vein isolation as the method for left atrial ablation.

In the intention-to-treat analyses, ablation was linked to a 14% relative reduction in the composite primary endpoint, a nonsignificant difference. All-cause mortality was a relative 15% lower in the ablation arm, also not statistically significant. A third prespecified, secondary endpoint, all-cause mortality plus cardiovascular hospitalization, was 17% lower in the ablated patients than in those on drug treatment in the intention-to-treat analysis, a statistically significant difference (P = .002).

The adverse event rate in the ablation arm was “surprisingly” low, said Dr. Packer, with a 3.9% rate of complications from catheter insertion (more than half were hematomas), a 3.4% rate of complications from catheter manipulation within the heart (2.2% involved pericardial effusions that required no intervention), and a 1.8% rate of ablation-related events, most commonly severe pericardial chest pain. “The risks of ablation seem to be lower than we thought,” he said, but quickly added the caveat that all ablation operators in CABANA had to have performed at least 100 ablation cases prior to the trial. The observed safety applies to operators “who know what they’re doing,” he said. Adverse events in the medically treated patients were typical for patients treated with amiodarone, Dr. Packer said, with the most common events hyper- or hypothyroidism, in 1.6%, and an allergic reaction, in 0.6%. In the intention-to-treat analysis the incidence of recurrent AF following a 90-day blanking period after ablation was 47% lower in the ablated patients relative to the drug-treated patients (P less than .0001).

Dr. Packer also presented an intriguing subgroup analysis for the primary endpoint that showed ablation had the best performance relative to medical management in patients younger than 65 years, patients with a history of heart failure, minority patients, and those who entered the trial in NYHA functional class II or III. The subgroup analysis showed a signal for worse performance from ablation in patients who were at least 75 years old. “I’m concerned about these older patients; we need to look into this,” Dr. Packer said. He also expressed optimism that the good performance of ablation in heart failure patients, while an exploratory finding, suggested confirmation of the results reported recently from the CASTLE-AF trial, which also showed good outcomes from catheter ablation for treating patients with heart failure and AF (N Engl J Med. 2018 Feb 1;378[5]:417-27).

The main qualification Dr. Packer voiced about the CABANA results is that not every AF patient should get ablation. “All treatments are not right for all patients. Not everyone with AF needs ablation. You need to talk with patients about it.” But despite this caution, he declared that the results had already changed his practice.

“I much less often now say to patients ‘let’s go with a drug and see what happens.’ I’d still do that if I wasn’t sure that a patient’s symptoms were caused by their AF” as opposed to their underlying heart disease, but if I’m pretty certain that their symptoms are caused by their AF over the past few months, I’ve become more likely to say that front-line ablation is reasonable,” Dr. Packer said.

CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from all four of these companies and also from several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Albert has been a consultant to Myokardia and Sanofi Aventis and has received research funding from Roche Diagnostics and St. Jude.

[email protected]

SOURCE: Packer DL et al. HRS 2018, Abstract B-LBCT01-05.

BOSTON – Results from the CABANA trial, the long-awaited, head-to-head comparison of percutaneous catheter ablation with drug therapy for the treatment of atrial fibrillation by restoring sinus rhythm, failed to accomplish what it was designed to prove.

That is, that catheter ablation was superior to medical management for a combined endpoint of all-cause death, stroke, serious bleeding, or cardiac arrest.

Mitchel L. Zoler/MDedge News

The dilemma that Dr. Ruskin and other physicians who heard the results voiced was how best to interpret the study’s primary results.

“This trial was designed to address whether ablation has an impact [compared with medical management] on hard endpoints, like mortality, and the intention-to-treat analysis showed no difference. I feel bound to adhere to the intention-to-treat analysis, the primary result” the traditional default arbiter of a randomized trial’s outcome, Dr. Ruskin said in an interview, “But intention-to-treat analyses are built on a foundation where most patients are maintained on their assigned treatment.”

Mitchel L. Zoler/MDedge News

“There was certainly no signal whatsoever of harm by taking patients to ablation early” in their management, agreed Dr. Ruskin. “I find that very reassuring and encouraging.”

CABANA (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial) started in 2009 and enrolled 2,204 patients with documented, new-onset paroxysmal or persistent atrial fibrillation (AF) at 110 centers in 10 countries. Patients averaged about 68 years of age, with about 15% at least 75 years old, and in general were what Dr. Packer characterized as a high-risk group, with a high prevalence of comorbidities: 23% with sleep apnea, 10% with cardiomyopathy, 15% with heart failure, 10% with a prior stroke or transient ischemic attack, and just over a third in a New York Heart Association functional class II or III. About 43% had paroxysmal AF, about 47% had persistent AF, and the remaining patients had long-standing persistent AF. The median duration of AF at the time of entry was just over 1 year.

The clinicians treating the patients assigned to medical management could decide on a case-by-case basis whether to use rate or rhythm control, and about 12% of patients received rate control. The trial design specified pulmonary-vein isolation as the method for left atrial ablation.

In the intention-to-treat analyses, ablation was linked to a 14% relative reduction in the composite primary endpoint, a nonsignificant difference. All-cause mortality was a relative 15% lower in the ablation arm, also not statistically significant. A third prespecified, secondary endpoint, all-cause mortality plus cardiovascular hospitalization, was 17% lower in the ablated patients than in those on drug treatment in the intention-to-treat analysis, a statistically significant difference (P = .002).

The adverse event rate in the ablation arm was “surprisingly” low, said Dr. Packer, with a 3.9% rate of complications from catheter insertion (more than half were hematomas), a 3.4% rate of complications from catheter manipulation within the heart (2.2% involved pericardial effusions that required no intervention), and a 1.8% rate of ablation-related events, most commonly severe pericardial chest pain. “The risks of ablation seem to be lower than we thought,” he said, but quickly added the caveat that all ablation operators in CABANA had to have performed at least 100 ablation cases prior to the trial. The observed safety applies to operators “who know what they’re doing,” he said. Adverse events in the medically treated patients were typical for patients treated with amiodarone, Dr. Packer said, with the most common events hyper- or hypothyroidism, in 1.6%, and an allergic reaction, in 0.6%. In the intention-to-treat analysis the incidence of recurrent AF following a 90-day blanking period after ablation was 47% lower in the ablated patients relative to the drug-treated patients (P less than .0001).

Dr. Packer also presented an intriguing subgroup analysis for the primary endpoint that showed ablation had the best performance relative to medical management in patients younger than 65 years, patients with a history of heart failure, minority patients, and those who entered the trial in NYHA functional class II or III. The subgroup analysis showed a signal for worse performance from ablation in patients who were at least 75 years old. “I’m concerned about these older patients; we need to look into this,” Dr. Packer said. He also expressed optimism that the good performance of ablation in heart failure patients, while an exploratory finding, suggested confirmation of the results reported recently from the CASTLE-AF trial, which also showed good outcomes from catheter ablation for treating patients with heart failure and AF (N Engl J Med. 2018 Feb 1;378[5]:417-27).

The main qualification Dr. Packer voiced about the CABANA results is that not every AF patient should get ablation. “All treatments are not right for all patients. Not everyone with AF needs ablation. You need to talk with patients about it.” But despite this caution, he declared that the results had already changed his practice.

“I much less often now say to patients ‘let’s go with a drug and see what happens.’ I’d still do that if I wasn’t sure that a patient’s symptoms were caused by their AF” as opposed to their underlying heart disease, but if I’m pretty certain that their symptoms are caused by their AF over the past few months, I’ve become more likely to say that front-line ablation is reasonable,” Dr. Packer said.

CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from all four of these companies and also from several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Albert has been a consultant to Myokardia and Sanofi Aventis and has received research funding from Roche Diagnostics and St. Jude.

[email protected]

SOURCE: Packer DL et al. HRS 2018, Abstract B-LBCT01-05.

BOSTON – Results from the CABANA trial, the long-awaited, head-to-head comparison of percutaneous catheter ablation with drug therapy for the treatment of atrial fibrillation by restoring sinus rhythm, failed to accomplish what it was designed to prove.

That is, that catheter ablation was superior to medical management for a combined endpoint of all-cause death, stroke, serious bleeding, or cardiac arrest.

Mitchel L. Zoler/MDedge News

The dilemma that Dr. Ruskin and other physicians who heard the results voiced was how best to interpret the study’s primary results.

“This trial was designed to address whether ablation has an impact [compared with medical management] on hard endpoints, like mortality, and the intention-to-treat analysis showed no difference. I feel bound to adhere to the intention-to-treat analysis, the primary result” the traditional default arbiter of a randomized trial’s outcome, Dr. Ruskin said in an interview, “But intention-to-treat analyses are built on a foundation where most patients are maintained on their assigned treatment.”

Mitchel L. Zoler/MDedge News

“There was certainly no signal whatsoever of harm by taking patients to ablation early” in their management, agreed Dr. Ruskin. “I find that very reassuring and encouraging.”

CABANA (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial) started in 2009 and enrolled 2,204 patients with documented, new-onset paroxysmal or persistent atrial fibrillation (AF) at 110 centers in 10 countries. Patients averaged about 68 years of age, with about 15% at least 75 years old, and in general were what Dr. Packer characterized as a high-risk group, with a high prevalence of comorbidities: 23% with sleep apnea, 10% with cardiomyopathy, 15% with heart failure, 10% with a prior stroke or transient ischemic attack, and just over a third in a New York Heart Association functional class II or III. About 43% had paroxysmal AF, about 47% had persistent AF, and the remaining patients had long-standing persistent AF. The median duration of AF at the time of entry was just over 1 year.

The clinicians treating the patients assigned to medical management could decide on a case-by-case basis whether to use rate or rhythm control, and about 12% of patients received rate control. The trial design specified pulmonary-vein isolation as the method for left atrial ablation.

In the intention-to-treat analyses, ablation was linked to a 14% relative reduction in the composite primary endpoint, a nonsignificant difference. All-cause mortality was a relative 15% lower in the ablation arm, also not statistically significant. A third prespecified, secondary endpoint, all-cause mortality plus cardiovascular hospitalization, was 17% lower in the ablated patients than in those on drug treatment in the intention-to-treat analysis, a statistically significant difference (P = .002).

The adverse event rate in the ablation arm was “surprisingly” low, said Dr. Packer, with a 3.9% rate of complications from catheter insertion (more than half were hematomas), a 3.4% rate of complications from catheter manipulation within the heart (2.2% involved pericardial effusions that required no intervention), and a 1.8% rate of ablation-related events, most commonly severe pericardial chest pain. “The risks of ablation seem to be lower than we thought,” he said, but quickly added the caveat that all ablation operators in CABANA had to have performed at least 100 ablation cases prior to the trial. The observed safety applies to operators “who know what they’re doing,” he said. Adverse events in the medically treated patients were typical for patients treated with amiodarone, Dr. Packer said, with the most common events hyper- or hypothyroidism, in 1.6%, and an allergic reaction, in 0.6%. In the intention-to-treat analysis the incidence of recurrent AF following a 90-day blanking period after ablation was 47% lower in the ablated patients relative to the drug-treated patients (P less than .0001).

Dr. Packer also presented an intriguing subgroup analysis for the primary endpoint that showed ablation had the best performance relative to medical management in patients younger than 65 years, patients with a history of heart failure, minority patients, and those who entered the trial in NYHA functional class II or III. The subgroup analysis showed a signal for worse performance from ablation in patients who were at least 75 years old. “I’m concerned about these older patients; we need to look into this,” Dr. Packer said. He also expressed optimism that the good performance of ablation in heart failure patients, while an exploratory finding, suggested confirmation of the results reported recently from the CASTLE-AF trial, which also showed good outcomes from catheter ablation for treating patients with heart failure and AF (N Engl J Med. 2018 Feb 1;378[5]:417-27).

The main qualification Dr. Packer voiced about the CABANA results is that not every AF patient should get ablation. “All treatments are not right for all patients. Not everyone with AF needs ablation. You need to talk with patients about it.” But despite this caution, he declared that the results had already changed his practice.

“I much less often now say to patients ‘let’s go with a drug and see what happens.’ I’d still do that if I wasn’t sure that a patient’s symptoms were caused by their AF” as opposed to their underlying heart disease, but if I’m pretty certain that their symptoms are caused by their AF over the past few months, I’ve become more likely to say that front-line ablation is reasonable,” Dr. Packer said.

CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from all four of these companies and also from several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Albert has been a consultant to Myokardia and Sanofi Aventis and has received research funding from Roche Diagnostics and St. Jude.

[email protected]

SOURCE: Packer DL et al. HRS 2018, Abstract B-LBCT01-05.

ABSTRACT

Soft tissue defects associated with exposed tendon pose difficult reconstructive problems because of tendon adhesions, poor range of motion, poor cosmetic appearance, and donor site morbidity. Dermal regeneration template is a skin substitute widely used in reconstructive surgery, including the occasional coverage of tendons. However, postoperative functionality of the tendons has not been well documented. We report a case of using dermal regeneration template for soft tissue reconstruction overlying tendons with loss of paratenon in a patient with Dupuytren’s contracture. Dermal regeneration template may offer an alternative option for immediate tendon coverage in the hand.

Soft tissue defects overlying exposed tendon with loss of paratenon often precipitate poor clinical outcomes because of the dichotomous demands of both closing the overlying soft-tissue defect and providing a gliding surface for the underlying tendons.¹ Although avoidance of adhesions and restoration of function are the primary goals of the procedure, satisfactory appearance is also desirable. Likewise, any form of coverage should ideally provide good vasculature required for complete healing and an early form of closure following débridement.² Simple skin grafts do not adequately meet these demands because they result in a high rate of tendon adhesions,³ and also are limited in patients with limited donor skin availability or questionable underlying wound bed viability, such as in scleroderma.

In order to reduce the frequency of tendon adhesions by creating a gliding surface, the use of interpositional materials, both artificial and biologic, has been employed with varying degrees of success, including cellophane, chitosan membrane, fibrin sealant, autogenous fascial flaps, and autogenous venous grafts.^4-7 Many of the autogenous flaps and grafts have been employed with good success.⁸ However, complications and donor site morbidity encourage alternative procedures, including the use of artificial substances.^2,8-10

We present our clinical experience with a patient who underwent successful placement of Integra (Integra LifeSciences) Dermal Regeneration Template (DRT) directly over exposed tendons with a subsequent full-thickness skin graft several weeks later. The procedures were performed per the manufacturer’s specifications, resulting in 2 stages of reconstruction. In our experience, DRT can offer immediate coverage unrestricted by wound size, and provides shorter operative time and decreased donor site and surgical morbidity compared with flap coverage, while demonstrating good cosmetic results. The patient provided written informed consent for print and electronic publication of this case report.

CASE

A 74-year-old right-handed man with Dupuytren’s contracture was evaluated for recurrent symptomatic contracture causing difficulty with daily activities. He reported palpable cords and contractures in the ring and small fingers of the right hand. He had 2 prior open surgical procedures, including palmar and digital fasciectomy of both hands. On the right hand, the ring and small fingers demonstrated 90° proximal interphalangeal (PIP) and 60° metacarpophalangeal (MCP) flexion contractures. Palpable central cords were present on the flexor surfaces of both the ring and small fingers. A well-healed surgical incision, performed 22 years earlier, was present over the palmar aspect of the ring finger.

Continue to: With consideration given...

With consideration given to the patient’s recurrent contracture after a prior surgical procedure, we discussed surgical excision of the diseased cords in order to eliminate the possibility of a second recurrence and maximize the gain of motion. Following discussion with the patient, we performed palmar and digital fasciectomy of the ring and small finger contractures. Postoperatively, the patient was followed closely for wound complications and vascular status. On his return to our clinic 11 days later, the patient was noted to have dehiscence of the digital wounds in the ring and small fingers (Figure 1). 

STAGE 1

During the first stage, completed 14 days following the index procedure, débridement of the wounds was performed, followed by provisional DRT coverage of the tendons, secured with 5-0 nylon sutures (Figure 2). 

STAGE 2

At approximately 2 weeks after application of the DRT, a full-thickness skin graft was applied. The thickness of the graft was chosen to allow for durable coverage of the palmar skin defects. Upon successful completion of the second stage, the patient was followed and evaluated for complete wound healing. On performing an examination 14 days after surgery, the ring and small fingers demonstrated only partially healed skin graft but significantly improved range of motion (ROM), with 40° to 90° arc of motion in the PIP joint and 25° to 90° arc of motion in the MCP joint (Figure 4). Owing to their limited size, the wounds were treated with dressing changes until successful healing (Figure 5).

Hand therapy was instituted to achieve maximum mobility for covered soft tissue and tendons and to maximize tendon gliding. At 1-year follow-up, the skin was fully healed and the patient’s active PIP motion was 30° to 90°, active MCP motion was 0° to 90°, and grip strength was 90 lb on both sides. The tendons glided under a well-vascularized tissue at the DRT placement site, and no secondary tenolysis procedure was deemed necessary.

DISCUSSION

Soft tissue defects with exposed tendons may offer a number of challenges for coverage. The primary concern is the creation of a gliding surface and the restoration of a functional tendon without adhesions.² However, surgeons must use their own clinical judgment when choosing the method of coverage so as to minimize the effects of donor site morbidity and maximize the overall functional and cosmetic outcomes. All options must be considered while selecting a material or flap that is likely to survive in the relatively avascular tendon plane.^2,8,11 When considering the reconstructive ladder, skin grafts may not represent a viable option in the presence of a nonvascularized wound bed, such as exposed tendon or bone, where paratenon or periosteum have been damaged. That leaves the surgeon with local flaps, regional flaps, free flaps, and skin substitutes.

Continue to : Before planning closure...

As Levin¹² noted in 1993, decisions regarding repair of any soft tissue defect may follow a well-delineated ladder beginning with the primary choice of split-thickness skin grafts and ending with free flaps. When treating tissue defects in the hand complex, flaps are an excellent option as they replace like with like, allow minimal scarring and early rehabilitation. ^13,14 Nevertheless, a few general disadvantages are inherent in flap procedure: increase in operating time, risk of flap loss, and in case of free flaps, knowledge, experience, and microsurgical ability.² In reference to complications, the rate of flap loss found by Khouri and colleagues¹⁵ was 4.1% with a 12.1% chance of incurring some measured complication, including wound dehiscence, arterial insufficiency, and flap necrosis.

Likewise, some of the conventional local and free flaps, including cutaneous and muscular flaps, prove ineffective in preventing tendon adhesions, create unsightly postoperative contours, or increase the area of trauma on the wounded hand, encouraging the use of free fascial flaps.¹¹ Among the wide array of potential free fascial flaps, the temporoparietal, scapular, lateral arm, radial forearm, and free serratus fascial flaps are some of the most popular for hand defects.^8,9 However, these procedures require an additional surgical site, meticulous dissection, microsurgical technique at times, and increased operating cost and time.^2,8-10 Furthermore, free fascial flaps have demonstrated occasional partial flap loss and a decreased survival of the overlying skin graft, leading some to advocate delayed skin graft placement.^10,16,17

On the basis of these complications, Bray and colleagues¹¹ noted that the utility of free flaps may be limited in smaller clinical settings. The primary disadvantage of using DRTs is the necessity for a second operative procedure to harvest and place the skin graft. Traditionally, this is performed 2 to 3 weeks after the initial DRT application. Nevertheless, a 1-stage procedure can be performed in an outpatient setup, minimizing the burden to the patient and the medical costs, followed by secondary intention healing.

In response to critics of the 2-stage technique, Sanger and colleagues¹⁸ described single-stage use of DRT with split-thickness skin grafts with placement of an overlying wound vacuum-assisted closure to help speed incorporation of the DRT and improve survival of the immediately grafted skin. Another viable alternative is the McCash open-palm technique.¹⁹ In the open-palm technique, a Brunner zigzag incision is made in the affected digit. A transverse incision is made in the palm. A partial fasciectomy is performed in the palm and digit. After release, the digital incision is closed, and the palmar incision is left open. Although this well-studied and well-reported technique is known to reduce the risk of flap necrosis due to tension and hematoma,²⁰ its main application is in the palm, as the name implies. Because in our patient the defect was palmar-digital with exposed “white structures,” we elected to use DRT.

Continue to: Although there is still...

ABSTRACT

Soft tissue defects associated with exposed tendon pose difficult reconstructive problems because of tendon adhesions, poor range of motion, poor cosmetic appearance, and donor site morbidity. Dermal regeneration template is a skin substitute widely used in reconstructive surgery, including the occasional coverage of tendons. However, postoperative functionality of the tendons has not been well documented. We report a case of using dermal regeneration template for soft tissue reconstruction overlying tendons with loss of paratenon in a patient with Dupuytren’s contracture. Dermal regeneration template may offer an alternative option for immediate tendon coverage in the hand.

Soft tissue defects overlying exposed tendon with loss of paratenon often precipitate poor clinical outcomes because of the dichotomous demands of both closing the overlying soft-tissue defect and providing a gliding surface for the underlying tendons.¹ Although avoidance of adhesions and restoration of function are the primary goals of the procedure, satisfactory appearance is also desirable. Likewise, any form of coverage should ideally provide good vasculature required for complete healing and an early form of closure following débridement.² Simple skin grafts do not adequately meet these demands because they result in a high rate of tendon adhesions,³ and also are limited in patients with limited donor skin availability or questionable underlying wound bed viability, such as in scleroderma.

In order to reduce the frequency of tendon adhesions by creating a gliding surface, the use of interpositional materials, both artificial and biologic, has been employed with varying degrees of success, including cellophane, chitosan membrane, fibrin sealant, autogenous fascial flaps, and autogenous venous grafts.^4-7 Many of the autogenous flaps and grafts have been employed with good success.⁸ However, complications and donor site morbidity encourage alternative procedures, including the use of artificial substances.^2,8-10

We present our clinical experience with a patient who underwent successful placement of Integra (Integra LifeSciences) Dermal Regeneration Template (DRT) directly over exposed tendons with a subsequent full-thickness skin graft several weeks later. The procedures were performed per the manufacturer’s specifications, resulting in 2 stages of reconstruction. In our experience, DRT can offer immediate coverage unrestricted by wound size, and provides shorter operative time and decreased donor site and surgical morbidity compared with flap coverage, while demonstrating good cosmetic results. The patient provided written informed consent for print and electronic publication of this case report.

CASE

A 74-year-old right-handed man with Dupuytren’s contracture was evaluated for recurrent symptomatic contracture causing difficulty with daily activities. He reported palpable cords and contractures in the ring and small fingers of the right hand. He had 2 prior open surgical procedures, including palmar and digital fasciectomy of both hands. On the right hand, the ring and small fingers demonstrated 90° proximal interphalangeal (PIP) and 60° metacarpophalangeal (MCP) flexion contractures. Palpable central cords were present on the flexor surfaces of both the ring and small fingers. A well-healed surgical incision, performed 22 years earlier, was present over the palmar aspect of the ring finger.

Continue to: With consideration given...

With consideration given to the patient’s recurrent contracture after a prior surgical procedure, we discussed surgical excision of the diseased cords in order to eliminate the possibility of a second recurrence and maximize the gain of motion. Following discussion with the patient, we performed palmar and digital fasciectomy of the ring and small finger contractures. Postoperatively, the patient was followed closely for wound complications and vascular status. On his return to our clinic 11 days later, the patient was noted to have dehiscence of the digital wounds in the ring and small fingers (Figure 1). 

STAGE 1

During the first stage, completed 14 days following the index procedure, débridement of the wounds was performed, followed by provisional DRT coverage of the tendons, secured with 5-0 nylon sutures (Figure 2). 

STAGE 2

At approximately 2 weeks after application of the DRT, a full-thickness skin graft was applied. The thickness of the graft was chosen to allow for durable coverage of the palmar skin defects. Upon successful completion of the second stage, the patient was followed and evaluated for complete wound healing. On performing an examination 14 days after surgery, the ring and small fingers demonstrated only partially healed skin graft but significantly improved range of motion (ROM), with 40° to 90° arc of motion in the PIP joint and 25° to 90° arc of motion in the MCP joint (Figure 4). Owing to their limited size, the wounds were treated with dressing changes until successful healing (Figure 5).

Hand therapy was instituted to achieve maximum mobility for covered soft tissue and tendons and to maximize tendon gliding. At 1-year follow-up, the skin was fully healed and the patient’s active PIP motion was 30° to 90°, active MCP motion was 0° to 90°, and grip strength was 90 lb on both sides. The tendons glided under a well-vascularized tissue at the DRT placement site, and no secondary tenolysis procedure was deemed necessary.

DISCUSSION

Soft tissue defects with exposed tendons may offer a number of challenges for coverage. The primary concern is the creation of a gliding surface and the restoration of a functional tendon without adhesions.² However, surgeons must use their own clinical judgment when choosing the method of coverage so as to minimize the effects of donor site morbidity and maximize the overall functional and cosmetic outcomes. All options must be considered while selecting a material or flap that is likely to survive in the relatively avascular tendon plane.^2,8,11 When considering the reconstructive ladder, skin grafts may not represent a viable option in the presence of a nonvascularized wound bed, such as exposed tendon or bone, where paratenon or periosteum have been damaged. That leaves the surgeon with local flaps, regional flaps, free flaps, and skin substitutes.

Continue to : Before planning closure...

As Levin¹² noted in 1993, decisions regarding repair of any soft tissue defect may follow a well-delineated ladder beginning with the primary choice of split-thickness skin grafts and ending with free flaps. When treating tissue defects in the hand complex, flaps are an excellent option as they replace like with like, allow minimal scarring and early rehabilitation. ^13,14 Nevertheless, a few general disadvantages are inherent in flap procedure: increase in operating time, risk of flap loss, and in case of free flaps, knowledge, experience, and microsurgical ability.² In reference to complications, the rate of flap loss found by Khouri and colleagues¹⁵ was 4.1% with a 12.1% chance of incurring some measured complication, including wound dehiscence, arterial insufficiency, and flap necrosis.

Likewise, some of the conventional local and free flaps, including cutaneous and muscular flaps, prove ineffective in preventing tendon adhesions, create unsightly postoperative contours, or increase the area of trauma on the wounded hand, encouraging the use of free fascial flaps.¹¹ Among the wide array of potential free fascial flaps, the temporoparietal, scapular, lateral arm, radial forearm, and free serratus fascial flaps are some of the most popular for hand defects.^8,9 However, these procedures require an additional surgical site, meticulous dissection, microsurgical technique at times, and increased operating cost and time.^2,8-10 Furthermore, free fascial flaps have demonstrated occasional partial flap loss and a decreased survival of the overlying skin graft, leading some to advocate delayed skin graft placement.^10,16,17

On the basis of these complications, Bray and colleagues¹¹ noted that the utility of free flaps may be limited in smaller clinical settings. The primary disadvantage of using DRTs is the necessity for a second operative procedure to harvest and place the skin graft. Traditionally, this is performed 2 to 3 weeks after the initial DRT application. Nevertheless, a 1-stage procedure can be performed in an outpatient setup, minimizing the burden to the patient and the medical costs, followed by secondary intention healing.

In response to critics of the 2-stage technique, Sanger and colleagues¹⁸ described single-stage use of DRT with split-thickness skin grafts with placement of an overlying wound vacuum-assisted closure to help speed incorporation of the DRT and improve survival of the immediately grafted skin. Another viable alternative is the McCash open-palm technique.¹⁹ In the open-palm technique, a Brunner zigzag incision is made in the affected digit. A transverse incision is made in the palm. A partial fasciectomy is performed in the palm and digit. After release, the digital incision is closed, and the palmar incision is left open. Although this well-studied and well-reported technique is known to reduce the risk of flap necrosis due to tension and hematoma,²⁰ its main application is in the palm, as the name implies. Because in our patient the defect was palmar-digital with exposed “white structures,” we elected to use DRT.

Continue to: Although there is still...

ABSTRACT

Soft tissue defects associated with exposed tendon pose difficult reconstructive problems because of tendon adhesions, poor range of motion, poor cosmetic appearance, and donor site morbidity. Dermal regeneration template is a skin substitute widely used in reconstructive surgery, including the occasional coverage of tendons. However, postoperative functionality of the tendons has not been well documented. We report a case of using dermal regeneration template for soft tissue reconstruction overlying tendons with loss of paratenon in a patient with Dupuytren’s contracture. Dermal regeneration template may offer an alternative option for immediate tendon coverage in the hand.

Soft tissue defects overlying exposed tendon with loss of paratenon often precipitate poor clinical outcomes because of the dichotomous demands of both closing the overlying soft-tissue defect and providing a gliding surface for the underlying tendons.¹ Although avoidance of adhesions and restoration of function are the primary goals of the procedure, satisfactory appearance is also desirable. Likewise, any form of coverage should ideally provide good vasculature required for complete healing and an early form of closure following débridement.² Simple skin grafts do not adequately meet these demands because they result in a high rate of tendon adhesions,³ and also are limited in patients with limited donor skin availability or questionable underlying wound bed viability, such as in scleroderma.

In order to reduce the frequency of tendon adhesions by creating a gliding surface, the use of interpositional materials, both artificial and biologic, has been employed with varying degrees of success, including cellophane, chitosan membrane, fibrin sealant, autogenous fascial flaps, and autogenous venous grafts.^4-7 Many of the autogenous flaps and grafts have been employed with good success.⁸ However, complications and donor site morbidity encourage alternative procedures, including the use of artificial substances.^2,8-10

We present our clinical experience with a patient who underwent successful placement of Integra (Integra LifeSciences) Dermal Regeneration Template (DRT) directly over exposed tendons with a subsequent full-thickness skin graft several weeks later. The procedures were performed per the manufacturer’s specifications, resulting in 2 stages of reconstruction. In our experience, DRT can offer immediate coverage unrestricted by wound size, and provides shorter operative time and decreased donor site and surgical morbidity compared with flap coverage, while demonstrating good cosmetic results. The patient provided written informed consent for print and electronic publication of this case report.

CASE

A 74-year-old right-handed man with Dupuytren’s contracture was evaluated for recurrent symptomatic contracture causing difficulty with daily activities. He reported palpable cords and contractures in the ring and small fingers of the right hand. He had 2 prior open surgical procedures, including palmar and digital fasciectomy of both hands. On the right hand, the ring and small fingers demonstrated 90° proximal interphalangeal (PIP) and 60° metacarpophalangeal (MCP) flexion contractures. Palpable central cords were present on the flexor surfaces of both the ring and small fingers. A well-healed surgical incision, performed 22 years earlier, was present over the palmar aspect of the ring finger.

Continue to: With consideration given...

With consideration given to the patient’s recurrent contracture after a prior surgical procedure, we discussed surgical excision of the diseased cords in order to eliminate the possibility of a second recurrence and maximize the gain of motion. Following discussion with the patient, we performed palmar and digital fasciectomy of the ring and small finger contractures. Postoperatively, the patient was followed closely for wound complications and vascular status. On his return to our clinic 11 days later, the patient was noted to have dehiscence of the digital wounds in the ring and small fingers (Figure 1). 

STAGE 1

During the first stage, completed 14 days following the index procedure, débridement of the wounds was performed, followed by provisional DRT coverage of the tendons, secured with 5-0 nylon sutures (Figure 2). 

STAGE 2

At approximately 2 weeks after application of the DRT, a full-thickness skin graft was applied. The thickness of the graft was chosen to allow for durable coverage of the palmar skin defects. Upon successful completion of the second stage, the patient was followed and evaluated for complete wound healing. On performing an examination 14 days after surgery, the ring and small fingers demonstrated only partially healed skin graft but significantly improved range of motion (ROM), with 40° to 90° arc of motion in the PIP joint and 25° to 90° arc of motion in the MCP joint (Figure 4). Owing to their limited size, the wounds were treated with dressing changes until successful healing (Figure 5).

Hand therapy was instituted to achieve maximum mobility for covered soft tissue and tendons and to maximize tendon gliding. At 1-year follow-up, the skin was fully healed and the patient’s active PIP motion was 30° to 90°, active MCP motion was 0° to 90°, and grip strength was 90 lb on both sides. The tendons glided under a well-vascularized tissue at the DRT placement site, and no secondary tenolysis procedure was deemed necessary.

DISCUSSION

Soft tissue defects with exposed tendons may offer a number of challenges for coverage. The primary concern is the creation of a gliding surface and the restoration of a functional tendon without adhesions.² However, surgeons must use their own clinical judgment when choosing the method of coverage so as to minimize the effects of donor site morbidity and maximize the overall functional and cosmetic outcomes. All options must be considered while selecting a material or flap that is likely to survive in the relatively avascular tendon plane.^2,8,11 When considering the reconstructive ladder, skin grafts may not represent a viable option in the presence of a nonvascularized wound bed, such as exposed tendon or bone, where paratenon or periosteum have been damaged. That leaves the surgeon with local flaps, regional flaps, free flaps, and skin substitutes.

Continue to : Before planning closure...

As Levin¹² noted in 1993, decisions regarding repair of any soft tissue defect may follow a well-delineated ladder beginning with the primary choice of split-thickness skin grafts and ending with free flaps. When treating tissue defects in the hand complex, flaps are an excellent option as they replace like with like, allow minimal scarring and early rehabilitation. ^13,14 Nevertheless, a few general disadvantages are inherent in flap procedure: increase in operating time, risk of flap loss, and in case of free flaps, knowledge, experience, and microsurgical ability.² In reference to complications, the rate of flap loss found by Khouri and colleagues¹⁵ was 4.1% with a 12.1% chance of incurring some measured complication, including wound dehiscence, arterial insufficiency, and flap necrosis.

Likewise, some of the conventional local and free flaps, including cutaneous and muscular flaps, prove ineffective in preventing tendon adhesions, create unsightly postoperative contours, or increase the area of trauma on the wounded hand, encouraging the use of free fascial flaps.¹¹ Among the wide array of potential free fascial flaps, the temporoparietal, scapular, lateral arm, radial forearm, and free serratus fascial flaps are some of the most popular for hand defects.^8,9 However, these procedures require an additional surgical site, meticulous dissection, microsurgical technique at times, and increased operating cost and time.^2,8-10 Furthermore, free fascial flaps have demonstrated occasional partial flap loss and a decreased survival of the overlying skin graft, leading some to advocate delayed skin graft placement.^10,16,17

On the basis of these complications, Bray and colleagues¹¹ noted that the utility of free flaps may be limited in smaller clinical settings. The primary disadvantage of using DRTs is the necessity for a second operative procedure to harvest and place the skin graft. Traditionally, this is performed 2 to 3 weeks after the initial DRT application. Nevertheless, a 1-stage procedure can be performed in an outpatient setup, minimizing the burden to the patient and the medical costs, followed by secondary intention healing.

In response to critics of the 2-stage technique, Sanger and colleagues¹⁸ described single-stage use of DRT with split-thickness skin grafts with placement of an overlying wound vacuum-assisted closure to help speed incorporation of the DRT and improve survival of the immediately grafted skin. Another viable alternative is the McCash open-palm technique.¹⁹ In the open-palm technique, a Brunner zigzag incision is made in the affected digit. A transverse incision is made in the palm. A partial fasciectomy is performed in the palm and digit. After release, the digital incision is closed, and the palmar incision is left open. Although this well-studied and well-reported technique is known to reduce the risk of flap necrosis due to tension and hematoma,²⁰ its main application is in the palm, as the name implies. Because in our patient the defect was palmar-digital with exposed “white structures,” we elected to use DRT.

Continue to: Although there is still...

Single-agent ibrutinib has had sustained efficacy and a rate of complete response that has increased over time, according to a 5-year follow-up report including 132 patients with chronic lymphocytic leukemia (CLL).

Efficacy has been maintained in both treatment-naive and relapsed/refractory CLL, despite the presence of high-risk genomic features in many patients, investigators reported in Blood.

Treatment has been well tolerated, and the occurrence of severe adverse events has diminished over time, according to Susan M. O’Brien, MD, of the Chao Family Comprehensive Cancer Center, University of California, Irvine, and her colleagues.

“The safety profile of ibrutinib over time remains acceptable and manageable, allowing almost one-half of the patients (48%) to be treated for more than 4 years and thus maximize response,” the investigators wrote.

The report was based on 5-year follow-up of patients with CLL who had been enrolled in a phase 1b/2 study (PCYC-1102) and an extension study (PCYC-1103). A total of 132 patients were evaluated, including 101 with relapsed/refractory disease and 31 who were treatment naive.

The overall response rate remained high, at 89% in this 5-year follow-up. Complete response rates increased over time, reaching 29% in treatment-naive patients and 10% in relapsed/refractory patients. In a previous report on 3-year follow-up for these patients, investigators reported complete response rates of 23% in the previously untreated group and 7% in the relapsed/refractory group. The new findings demonstrate “deepening of responses” with continued ibrutinib therapy, Dr. O’Brien and her coauthors wrote.

The 5-year rate of progression-free survival was 44% for relapsed/refractory patients and 92% for treatment-naive patients in this study. Median progression-free survival was 51 months for the relapsed/refractory cohort. “[Progression-free survival] with single-agent ibrutinib in [treatment-naive] patients appears particularly favorable, because the median has not been reached,” investigators wrote.

SOURCE: O’Brien S et al. Blood. 2018;131(17):1910-9.

Single-agent ibrutinib has had sustained efficacy and a rate of complete response that has increased over time, according to a 5-year follow-up report including 132 patients with chronic lymphocytic leukemia (CLL).

Efficacy has been maintained in both treatment-naive and relapsed/refractory CLL, despite the presence of high-risk genomic features in many patients, investigators reported in Blood.

Treatment has been well tolerated, and the occurrence of severe adverse events has diminished over time, according to Susan M. O’Brien, MD, of the Chao Family Comprehensive Cancer Center, University of California, Irvine, and her colleagues.

“The safety profile of ibrutinib over time remains acceptable and manageable, allowing almost one-half of the patients (48%) to be treated for more than 4 years and thus maximize response,” the investigators wrote.

The report was based on 5-year follow-up of patients with CLL who had been enrolled in a phase 1b/2 study (PCYC-1102) and an extension study (PCYC-1103). A total of 132 patients were evaluated, including 101 with relapsed/refractory disease and 31 who were treatment naive.

The overall response rate remained high, at 89% in this 5-year follow-up. Complete response rates increased over time, reaching 29% in treatment-naive patients and 10% in relapsed/refractory patients. In a previous report on 3-year follow-up for these patients, investigators reported complete response rates of 23% in the previously untreated group and 7% in the relapsed/refractory group. The new findings demonstrate “deepening of responses” with continued ibrutinib therapy, Dr. O’Brien and her coauthors wrote.

The 5-year rate of progression-free survival was 44% for relapsed/refractory patients and 92% for treatment-naive patients in this study. Median progression-free survival was 51 months for the relapsed/refractory cohort. “[Progression-free survival] with single-agent ibrutinib in [treatment-naive] patients appears particularly favorable, because the median has not been reached,” investigators wrote.

SOURCE: O’Brien S et al. Blood. 2018;131(17):1910-9.

Single-agent ibrutinib has had sustained efficacy and a rate of complete response that has increased over time, according to a 5-year follow-up report including 132 patients with chronic lymphocytic leukemia (CLL).

Efficacy has been maintained in both treatment-naive and relapsed/refractory CLL, despite the presence of high-risk genomic features in many patients, investigators reported in Blood.

Treatment has been well tolerated, and the occurrence of severe adverse events has diminished over time, according to Susan M. O’Brien, MD, of the Chao Family Comprehensive Cancer Center, University of California, Irvine, and her colleagues.

“The safety profile of ibrutinib over time remains acceptable and manageable, allowing almost one-half of the patients (48%) to be treated for more than 4 years and thus maximize response,” the investigators wrote.

The report was based on 5-year follow-up of patients with CLL who had been enrolled in a phase 1b/2 study (PCYC-1102) and an extension study (PCYC-1103). A total of 132 patients were evaluated, including 101 with relapsed/refractory disease and 31 who were treatment naive.

The overall response rate remained high, at 89% in this 5-year follow-up. Complete response rates increased over time, reaching 29% in treatment-naive patients and 10% in relapsed/refractory patients. In a previous report on 3-year follow-up for these patients, investigators reported complete response rates of 23% in the previously untreated group and 7% in the relapsed/refractory group. The new findings demonstrate “deepening of responses” with continued ibrutinib therapy, Dr. O’Brien and her coauthors wrote.

The 5-year rate of progression-free survival was 44% for relapsed/refractory patients and 92% for treatment-naive patients in this study. Median progression-free survival was 51 months for the relapsed/refractory cohort. “[Progression-free survival] with single-agent ibrutinib in [treatment-naive] patients appears particularly favorable, because the median has not been reached,” investigators wrote.

SOURCE: O’Brien S et al. Blood. 2018;131(17):1910-9.

LOS ANGELES – Patients with multiple sclerosis who are treated with subcutaneous interferon beta-1a have no increase in stroke risk, compared with those treated with placebo, according to pooled data from clinical trials and a safety database analysis.

Studies have shown that MS patients have a greater risk of stroke, compared with the general population, but the data with respect to the risk of stroke following interferon treatment are limited, Alan Gillett, PhD, explained in his presentation at the annual meeting of the American Academy of Neurology. He noted that a 2017 report on a series of nested case-control studies showed a 1.8-fold increased risk of stroke in relapsing-remitting MS patients who received interferon.

In the new analysis presented at the meeting, there was a trend toward decreased stroke incidence among patients treated with subcutaneous interferon beta-1a. Stroke incidence was 0.025 per 100 patient-years (25 events) in patients treated with subcutaneous interferon beta-1a vs. 0.051 per 100 patient-years (11 events) in patients who received placebo across 17 phase 2-4 clinical trials. The incidence rate ratio (IRR) and hazard ratio for stroke in interferon- vs. placebo-treated patients were 0.486 and 0.496, respectively, reported Dr. Gillett of EMD Serono, Mississauga, Ont.

Further, no significant difference in stroke incidence was seen between the treatment and placebo groups based on treatment duration, Dr. Gillett said. The IRR in patients treated for less than 2 years was 0.602 vs. 0.469 in those treated for 2 or more years.

“The incidence rate ratio [in both groups] was very comparable to that overall, so this indicates that treatment duration had little impact on the incidence rate of stroke,” he said.

The same was true in an analysis based on dose; the IRRs were similar in those exposed to 44 mcg vs. placebo, and in those receiving any dose vs. placebo, he noted.

The analysis is based on reports of 569 cerebrovascular events occurring over 19 years (2.7 per 10,000 patient-years) in 1,594,414 patient-years of follow-up through May 22, 2017, in the Global Patient Safety Database.

[email protected]

SOURCE: Sabidó M et al. Neurology. 2018 Apr 90(15 Suppl.):S36.008.

LOS ANGELES – Patients with multiple sclerosis who are treated with subcutaneous interferon beta-1a have no increase in stroke risk, compared with those treated with placebo, according to pooled data from clinical trials and a safety database analysis.

Studies have shown that MS patients have a greater risk of stroke, compared with the general population, but the data with respect to the risk of stroke following interferon treatment are limited, Alan Gillett, PhD, explained in his presentation at the annual meeting of the American Academy of Neurology. He noted that a 2017 report on a series of nested case-control studies showed a 1.8-fold increased risk of stroke in relapsing-remitting MS patients who received interferon.

In the new analysis presented at the meeting, there was a trend toward decreased stroke incidence among patients treated with subcutaneous interferon beta-1a. Stroke incidence was 0.025 per 100 patient-years (25 events) in patients treated with subcutaneous interferon beta-1a vs. 0.051 per 100 patient-years (11 events) in patients who received placebo across 17 phase 2-4 clinical trials. The incidence rate ratio (IRR) and hazard ratio for stroke in interferon- vs. placebo-treated patients were 0.486 and 0.496, respectively, reported Dr. Gillett of EMD Serono, Mississauga, Ont.

Further, no significant difference in stroke incidence was seen between the treatment and placebo groups based on treatment duration, Dr. Gillett said. The IRR in patients treated for less than 2 years was 0.602 vs. 0.469 in those treated for 2 or more years.

“The incidence rate ratio [in both groups] was very comparable to that overall, so this indicates that treatment duration had little impact on the incidence rate of stroke,” he said.

The same was true in an analysis based on dose; the IRRs were similar in those exposed to 44 mcg vs. placebo, and in those receiving any dose vs. placebo, he noted.

The analysis is based on reports of 569 cerebrovascular events occurring over 19 years (2.7 per 10,000 patient-years) in 1,594,414 patient-years of follow-up through May 22, 2017, in the Global Patient Safety Database.

[email protected]

SOURCE: Sabidó M et al. Neurology. 2018 Apr 90(15 Suppl.):S36.008.

LOS ANGELES – Patients with multiple sclerosis who are treated with subcutaneous interferon beta-1a have no increase in stroke risk, compared with those treated with placebo, according to pooled data from clinical trials and a safety database analysis.

Studies have shown that MS patients have a greater risk of stroke, compared with the general population, but the data with respect to the risk of stroke following interferon treatment are limited, Alan Gillett, PhD, explained in his presentation at the annual meeting of the American Academy of Neurology. He noted that a 2017 report on a series of nested case-control studies showed a 1.8-fold increased risk of stroke in relapsing-remitting MS patients who received interferon.

In the new analysis presented at the meeting, there was a trend toward decreased stroke incidence among patients treated with subcutaneous interferon beta-1a. Stroke incidence was 0.025 per 100 patient-years (25 events) in patients treated with subcutaneous interferon beta-1a vs. 0.051 per 100 patient-years (11 events) in patients who received placebo across 17 phase 2-4 clinical trials. The incidence rate ratio (IRR) and hazard ratio for stroke in interferon- vs. placebo-treated patients were 0.486 and 0.496, respectively, reported Dr. Gillett of EMD Serono, Mississauga, Ont.

Further, no significant difference in stroke incidence was seen between the treatment and placebo groups based on treatment duration, Dr. Gillett said. The IRR in patients treated for less than 2 years was 0.602 vs. 0.469 in those treated for 2 or more years.

“The incidence rate ratio [in both groups] was very comparable to that overall, so this indicates that treatment duration had little impact on the incidence rate of stroke,” he said.

The same was true in an analysis based on dose; the IRRs were similar in those exposed to 44 mcg vs. placebo, and in those receiving any dose vs. placebo, he noted.

The analysis is based on reports of 569 cerebrovascular events occurring over 19 years (2.7 per 10,000 patient-years) in 1,594,414 patient-years of follow-up through May 22, 2017, in the Global Patient Safety Database.

[email protected]

SOURCE: Sabidó M et al. Neurology. 2018 Apr 90(15 Suppl.):S36.008.

WASHINGTON – The evidence linking firearm access and suicide completion is largely ignored in current U.S. discussions on guns, Michael D. Anestis, PhD, said at the annual conference of the American Association of Suicidology.

“Only a tiny fraction of media discussions on gun deaths involve suicide. We must make a concerted and sustained effort to change this conversation,” said Dr. Anestis, a clinical psychologist at the University of Southern Mississippi in Hattiesburg. When the relationship between firearms and suicide is discussed, it often is as a “footnote” and includes a lot of inaccurate information.

Mitchel L. Zoler/MDedge News

Results from questionnaires given to 253 U.S. soldiers showed a link between accumulated combat experiences and an increased acquired capability for suicide. But additional research from his group showed that another route to acquiring “capability” for suicide, such as fearlessness of death, can occur through exposure to violent video games.

Dr. Anestis had no disclosures.

[email protected]

;
 

WASHINGTON – The evidence linking firearm access and suicide completion is largely ignored in current U.S. discussions on guns, Michael D. Anestis, PhD, said at the annual conference of the American Association of Suicidology.

“Only a tiny fraction of media discussions on gun deaths involve suicide. We must make a concerted and sustained effort to change this conversation,” said Dr. Anestis, a clinical psychologist at the University of Southern Mississippi in Hattiesburg. When the relationship between firearms and suicide is discussed, it often is as a “footnote” and includes a lot of inaccurate information.

Mitchel L. Zoler/MDedge News

Results from questionnaires given to 253 U.S. soldiers showed a link between accumulated combat experiences and an increased acquired capability for suicide. But additional research from his group showed that another route to acquiring “capability” for suicide, such as fearlessness of death, can occur through exposure to violent video games.

Dr. Anestis had no disclosures.

[email protected]

;
 

WASHINGTON – The evidence linking firearm access and suicide completion is largely ignored in current U.S. discussions on guns, Michael D. Anestis, PhD, said at the annual conference of the American Association of Suicidology.

“Only a tiny fraction of media discussions on gun deaths involve suicide. We must make a concerted and sustained effort to change this conversation,” said Dr. Anestis, a clinical psychologist at the University of Southern Mississippi in Hattiesburg. When the relationship between firearms and suicide is discussed, it often is as a “footnote” and includes a lot of inaccurate information.

Mitchel L. Zoler/MDedge News

Results from questionnaires given to 253 U.S. soldiers showed a link between accumulated combat experiences and an increased acquired capability for suicide. But additional research from his group showed that another route to acquiring “capability” for suicide, such as fearlessness of death, can occur through exposure to violent video games.

Dr. Anestis had no disclosures.

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