Health Canada shortens deferral for MSM blood donors

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Health Canada shortens deferral for MSM blood donors

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Health Canada has decided to change its policy regarding blood donations from men who have sex with men (MSM).

The policy has been that MSMs can only donate blood if they have abstained from sexual contact with another man for a period of 5 years. As of August 15, that period will be shortened to 1 year.

The change is a result of proposals from Canada’s blood operators, Canadian Blood Services and Héma-Québec.

These proposals included scientific data indicating that decreasing the deferral period for MSMs would not affect the safety of the blood supply.

The change brings Canada in line with several other countries that have implemented a 1-year deferral period for MSM blood donors, including the US, Australia, New Zealand, England, Scotland, and France.

Health Canada said the country’s blood system continues to have rigorous scientific and screening processes in place to protect the safety of Canadians.

Canadian Blood Services and Héma-Québec will continue to screen all donations for HIV and other infections. As an extra precaution, Health Canada and the blood operators will monitor donations from new donors to see if there is an increase in HIV or other infection rates.

According to Health Canada, there has not been a single HIV infection from blood transfusion in Canada in 25 years.

However, the frequency of HIV infection remains higher among MSMs (10%) than among heterosexuals or lesbians (less than 1% for both). And it was because of this that Canada implemented the 5-year deferral period for MSM blood donors. Prior to the implementation of that policy, MSMs were completely barred from donating blood in Canada.

“It has been demonstrated that implementing a 5-year temporary exclusion in 2013 had no impact on the safety of the transfusion system,” said Marc Germain, vice-president of medical affairs at Héma-Québec.

“As a result of recent data concerning transfusion safety, the exclusion policy applied to men who have had sex with another man could be reviewed. [The new 1-year deferral period] is scientifically justified and will not endanger the very high level of safety of blood products.”

“This is an exciting, incremental step forward in updating our blood donation criteria based on the latest scientific evidence,” said Graham Sher, chief executive officer of Canadian Blood Services.

“Canadian Blood Services is dedicated to being as minimally restrictive as possible while also maintaining the safety of the blood supply.”

Canadian Blood Services said it is exploring the possibility of moving toward behavior-based screening of blood donors. The organization is working with researchers, the LGBTQ community, patient groups, and other stakeholders to determine how best to gather the scientific evidence required to determine future changes to donor eligibility criteria.

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Blood donation

Photo by Marja Helander

Health Canada has decided to change its policy regarding blood donations from men who have sex with men (MSM).

The policy has been that MSMs can only donate blood if they have abstained from sexual contact with another man for a period of 5 years. As of August 15, that period will be shortened to 1 year.

The change is a result of proposals from Canada’s blood operators, Canadian Blood Services and Héma-Québec.

These proposals included scientific data indicating that decreasing the deferral period for MSMs would not affect the safety of the blood supply.

The change brings Canada in line with several other countries that have implemented a 1-year deferral period for MSM blood donors, including the US, Australia, New Zealand, England, Scotland, and France.

Health Canada said the country’s blood system continues to have rigorous scientific and screening processes in place to protect the safety of Canadians.

Canadian Blood Services and Héma-Québec will continue to screen all donations for HIV and other infections. As an extra precaution, Health Canada and the blood operators will monitor donations from new donors to see if there is an increase in HIV or other infection rates.

According to Health Canada, there has not been a single HIV infection from blood transfusion in Canada in 25 years.

However, the frequency of HIV infection remains higher among MSMs (10%) than among heterosexuals or lesbians (less than 1% for both). And it was because of this that Canada implemented the 5-year deferral period for MSM blood donors. Prior to the implementation of that policy, MSMs were completely barred from donating blood in Canada.

“It has been demonstrated that implementing a 5-year temporary exclusion in 2013 had no impact on the safety of the transfusion system,” said Marc Germain, vice-president of medical affairs at Héma-Québec.

“As a result of recent data concerning transfusion safety, the exclusion policy applied to men who have had sex with another man could be reviewed. [The new 1-year deferral period] is scientifically justified and will not endanger the very high level of safety of blood products.”

“This is an exciting, incremental step forward in updating our blood donation criteria based on the latest scientific evidence,” said Graham Sher, chief executive officer of Canadian Blood Services.

“Canadian Blood Services is dedicated to being as minimally restrictive as possible while also maintaining the safety of the blood supply.”

Canadian Blood Services said it is exploring the possibility of moving toward behavior-based screening of blood donors. The organization is working with researchers, the LGBTQ community, patient groups, and other stakeholders to determine how best to gather the scientific evidence required to determine future changes to donor eligibility criteria.

Blood donation

Photo by Marja Helander

Health Canada has decided to change its policy regarding blood donations from men who have sex with men (MSM).

The policy has been that MSMs can only donate blood if they have abstained from sexual contact with another man for a period of 5 years. As of August 15, that period will be shortened to 1 year.

The change is a result of proposals from Canada’s blood operators, Canadian Blood Services and Héma-Québec.

These proposals included scientific data indicating that decreasing the deferral period for MSMs would not affect the safety of the blood supply.

The change brings Canada in line with several other countries that have implemented a 1-year deferral period for MSM blood donors, including the US, Australia, New Zealand, England, Scotland, and France.

Health Canada said the country’s blood system continues to have rigorous scientific and screening processes in place to protect the safety of Canadians.

Canadian Blood Services and Héma-Québec will continue to screen all donations for HIV and other infections. As an extra precaution, Health Canada and the blood operators will monitor donations from new donors to see if there is an increase in HIV or other infection rates.

According to Health Canada, there has not been a single HIV infection from blood transfusion in Canada in 25 years.

However, the frequency of HIV infection remains higher among MSMs (10%) than among heterosexuals or lesbians (less than 1% for both). And it was because of this that Canada implemented the 5-year deferral period for MSM blood donors. Prior to the implementation of that policy, MSMs were completely barred from donating blood in Canada.

“It has been demonstrated that implementing a 5-year temporary exclusion in 2013 had no impact on the safety of the transfusion system,” said Marc Germain, vice-president of medical affairs at Héma-Québec.

“As a result of recent data concerning transfusion safety, the exclusion policy applied to men who have had sex with another man could be reviewed. [The new 1-year deferral period] is scientifically justified and will not endanger the very high level of safety of blood products.”

“This is an exciting, incremental step forward in updating our blood donation criteria based on the latest scientific evidence,” said Graham Sher, chief executive officer of Canadian Blood Services.

“Canadian Blood Services is dedicated to being as minimally restrictive as possible while also maintaining the safety of the blood supply.”

Canadian Blood Services said it is exploring the possibility of moving toward behavior-based screening of blood donors. The organization is working with researchers, the LGBTQ community, patient groups, and other stakeholders to determine how best to gather the scientific evidence required to determine future changes to donor eligibility criteria.

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HIV research update: Early June 2016

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A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Interventions that seek to promptly house homeless individuals might assist in maximizing the clinical and public health benefits of antiretroviral therapy among people living with HIV/AIDS, according to a study in AIDS Care.

©alexskopje/ThinkStock.com

MRSA colonization among HIV-infected youth is more closely related to living in a low-income or slum community than to HIV-related clinical factors, according to a study in the Pediatric Infectious Disease Journal.

Marijuana use was not associated with progression to significant liver fibrosis, in a large cohort study of HIV/hepatitis C virus (HCV) co-infected women. Alcohol use may better predict fibrosis progression in HIV/HCV co-infected women, the authors said.

More than 60% of deaths occurring in a rural South African community between 1992 and 2013 could be attributed directly or indirectly to HIV, according to a recent study. However, the authors noted that there has been an increasing level of non-HIV mortality, which has important implications for local health care provision.

A study in AIDS Care found that providers value same-day, electronic, patient-reported measures for use in clinical HIV care, with the condition that patient-reported outcomes are 1) tailored to be the most clinically relevant to their population; 2) well integrated into clinic flow; and 3) easy to interpret, highlighting chief patient concerns and changes over time.

Investigators found that nasal and salivary samples can be collected from HIV-infected patients in a standardized manner over repeated visits in both low and high resource settings, and these methods may be used in support of future HIV vaccine clinical trials.

A study in the Journal of Infectious Diseases found no intrinsic effect of viral subtype on the efficacy of tenofovir-containing regimens for treating HIV-1 subtype C infections. There were no differences between subtypes C and non-B/C in either univariate or multivariate analysis.

New research provides preliminary evidence that heavy drinking may increase a key inflammatory marker in HIV-infected individuals with suppressed infection.

The phase III Women AntiretroViral Efficacy and Safety study (WAVES) showed that clinical trials of antiretroviral regimens in global and diverse populations of treatment-naive women are possible, investigators concluded. They said their findings support guidelines recommending integrase inhibitor–based regimens in first-line antiretroviral therapy.

A hybrid mobile strategy for HIV testing of adults was leveraged successfully to reach adolescents for HIV treatment and prevention, according to a study in Kenya and Uganda.

With viral suppression induced by combination antiretroviral therapy, women have less reduction in key markers of inflammation and immune activation, compared with men, report the authors of a study in JAIDS.

The transfer of HIV-1-p17-specific T-cell receptors (TCRs) into T-cells is functional both in HIV-1–infected patients and in healthy blood donors, according to a study in the journal AIDS. The authors say TCR-transfer is a promising method to boost the immune system against HIV-1.

HIV-1 subtype C (HIV-1C) exhibits lower in vivo fitness, compared with HIV-1B, which allows successful treatment despite high baseline viral loads, a new study demonstrated. The lower fitness – and potentially lower virulence – together with high viral loads may underlie the heightened transmission potential of HIV-1C and its growing global spread.

Thailand has achieved World Health Organization targets for elimination of mother-to-child-transmission of HIV and can serve as a model for other countries, according to a report in MMWR.

Regular CD4 testing may be unnecessary for virally suppressed children aged 5-15 years with CD4 greater than or equal to 500 cells/mm3, according to a study published in the Journal of the Pediatric Infectious Diseases Society.

Investigators at Case Western Reserve University, Cleveland found that 24 weeks of 10 mg daily rosuvastatin decreases plasma coenzyme Q10 concentration and increases CoQ10/LDL ratio in HIV-infected patients on antiretroviral therapy.

Researchers from the University of California, San Francisco, and Yale University, New Haven, Conn., found that half of people newly infected with HIV experience neurologic issues that are generally not severe and usually resolve after starting antiretroviral therapy.

A study of HIV-infected individuals in metropolitan Washington identified high prevalence of transmitted drug resistance, regardless of gender. The authors said active surveillance for transmitted drug resistance is needed to guide antiretroviral usage and analyses of risk group contributions to HIV transmission and resistance.

Single-nucleotide polymorphisms in genes encoding the Toll-like receptor 4 (TLR4) and CD14 are independently associated with long-term CD4+ T-cell recovery in HIV-infected individuals after antiretroviral therapy, according to a study in the journal AIDS.

 

 

In HIV/HCV co-infected individuals, the crude incidence of hepatocellular carcinoma increased from 2001 to 2014, while other liver events declined, according to a recent study.

[email protected]

On Twitter @richpizzi

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A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Interventions that seek to promptly house homeless individuals might assist in maximizing the clinical and public health benefits of antiretroviral therapy among people living with HIV/AIDS, according to a study in AIDS Care.

©alexskopje/ThinkStock.com

MRSA colonization among HIV-infected youth is more closely related to living in a low-income or slum community than to HIV-related clinical factors, according to a study in the Pediatric Infectious Disease Journal.

Marijuana use was not associated with progression to significant liver fibrosis, in a large cohort study of HIV/hepatitis C virus (HCV) co-infected women. Alcohol use may better predict fibrosis progression in HIV/HCV co-infected women, the authors said.

More than 60% of deaths occurring in a rural South African community between 1992 and 2013 could be attributed directly or indirectly to HIV, according to a recent study. However, the authors noted that there has been an increasing level of non-HIV mortality, which has important implications for local health care provision.

A study in AIDS Care found that providers value same-day, electronic, patient-reported measures for use in clinical HIV care, with the condition that patient-reported outcomes are 1) tailored to be the most clinically relevant to their population; 2) well integrated into clinic flow; and 3) easy to interpret, highlighting chief patient concerns and changes over time.

Investigators found that nasal and salivary samples can be collected from HIV-infected patients in a standardized manner over repeated visits in both low and high resource settings, and these methods may be used in support of future HIV vaccine clinical trials.

A study in the Journal of Infectious Diseases found no intrinsic effect of viral subtype on the efficacy of tenofovir-containing regimens for treating HIV-1 subtype C infections. There were no differences between subtypes C and non-B/C in either univariate or multivariate analysis.

New research provides preliminary evidence that heavy drinking may increase a key inflammatory marker in HIV-infected individuals with suppressed infection.

The phase III Women AntiretroViral Efficacy and Safety study (WAVES) showed that clinical trials of antiretroviral regimens in global and diverse populations of treatment-naive women are possible, investigators concluded. They said their findings support guidelines recommending integrase inhibitor–based regimens in first-line antiretroviral therapy.

A hybrid mobile strategy for HIV testing of adults was leveraged successfully to reach adolescents for HIV treatment and prevention, according to a study in Kenya and Uganda.

With viral suppression induced by combination antiretroviral therapy, women have less reduction in key markers of inflammation and immune activation, compared with men, report the authors of a study in JAIDS.

The transfer of HIV-1-p17-specific T-cell receptors (TCRs) into T-cells is functional both in HIV-1–infected patients and in healthy blood donors, according to a study in the journal AIDS. The authors say TCR-transfer is a promising method to boost the immune system against HIV-1.

HIV-1 subtype C (HIV-1C) exhibits lower in vivo fitness, compared with HIV-1B, which allows successful treatment despite high baseline viral loads, a new study demonstrated. The lower fitness – and potentially lower virulence – together with high viral loads may underlie the heightened transmission potential of HIV-1C and its growing global spread.

Thailand has achieved World Health Organization targets for elimination of mother-to-child-transmission of HIV and can serve as a model for other countries, according to a report in MMWR.

Regular CD4 testing may be unnecessary for virally suppressed children aged 5-15 years with CD4 greater than or equal to 500 cells/mm3, according to a study published in the Journal of the Pediatric Infectious Diseases Society.

Investigators at Case Western Reserve University, Cleveland found that 24 weeks of 10 mg daily rosuvastatin decreases plasma coenzyme Q10 concentration and increases CoQ10/LDL ratio in HIV-infected patients on antiretroviral therapy.

Researchers from the University of California, San Francisco, and Yale University, New Haven, Conn., found that half of people newly infected with HIV experience neurologic issues that are generally not severe and usually resolve after starting antiretroviral therapy.

A study of HIV-infected individuals in metropolitan Washington identified high prevalence of transmitted drug resistance, regardless of gender. The authors said active surveillance for transmitted drug resistance is needed to guide antiretroviral usage and analyses of risk group contributions to HIV transmission and resistance.

Single-nucleotide polymorphisms in genes encoding the Toll-like receptor 4 (TLR4) and CD14 are independently associated with long-term CD4+ T-cell recovery in HIV-infected individuals after antiretroviral therapy, according to a study in the journal AIDS.

 

 

In HIV/HCV co-infected individuals, the crude incidence of hepatocellular carcinoma increased from 2001 to 2014, while other liver events declined, according to a recent study.

[email protected]

On Twitter @richpizzi

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Interventions that seek to promptly house homeless individuals might assist in maximizing the clinical and public health benefits of antiretroviral therapy among people living with HIV/AIDS, according to a study in AIDS Care.

©alexskopje/ThinkStock.com

MRSA colonization among HIV-infected youth is more closely related to living in a low-income or slum community than to HIV-related clinical factors, according to a study in the Pediatric Infectious Disease Journal.

Marijuana use was not associated with progression to significant liver fibrosis, in a large cohort study of HIV/hepatitis C virus (HCV) co-infected women. Alcohol use may better predict fibrosis progression in HIV/HCV co-infected women, the authors said.

More than 60% of deaths occurring in a rural South African community between 1992 and 2013 could be attributed directly or indirectly to HIV, according to a recent study. However, the authors noted that there has been an increasing level of non-HIV mortality, which has important implications for local health care provision.

A study in AIDS Care found that providers value same-day, electronic, patient-reported measures for use in clinical HIV care, with the condition that patient-reported outcomes are 1) tailored to be the most clinically relevant to their population; 2) well integrated into clinic flow; and 3) easy to interpret, highlighting chief patient concerns and changes over time.

Investigators found that nasal and salivary samples can be collected from HIV-infected patients in a standardized manner over repeated visits in both low and high resource settings, and these methods may be used in support of future HIV vaccine clinical trials.

A study in the Journal of Infectious Diseases found no intrinsic effect of viral subtype on the efficacy of tenofovir-containing regimens for treating HIV-1 subtype C infections. There were no differences between subtypes C and non-B/C in either univariate or multivariate analysis.

New research provides preliminary evidence that heavy drinking may increase a key inflammatory marker in HIV-infected individuals with suppressed infection.

The phase III Women AntiretroViral Efficacy and Safety study (WAVES) showed that clinical trials of antiretroviral regimens in global and diverse populations of treatment-naive women are possible, investigators concluded. They said their findings support guidelines recommending integrase inhibitor–based regimens in first-line antiretroviral therapy.

A hybrid mobile strategy for HIV testing of adults was leveraged successfully to reach adolescents for HIV treatment and prevention, according to a study in Kenya and Uganda.

With viral suppression induced by combination antiretroviral therapy, women have less reduction in key markers of inflammation and immune activation, compared with men, report the authors of a study in JAIDS.

The transfer of HIV-1-p17-specific T-cell receptors (TCRs) into T-cells is functional both in HIV-1–infected patients and in healthy blood donors, according to a study in the journal AIDS. The authors say TCR-transfer is a promising method to boost the immune system against HIV-1.

HIV-1 subtype C (HIV-1C) exhibits lower in vivo fitness, compared with HIV-1B, which allows successful treatment despite high baseline viral loads, a new study demonstrated. The lower fitness – and potentially lower virulence – together with high viral loads may underlie the heightened transmission potential of HIV-1C and its growing global spread.

Thailand has achieved World Health Organization targets for elimination of mother-to-child-transmission of HIV and can serve as a model for other countries, according to a report in MMWR.

Regular CD4 testing may be unnecessary for virally suppressed children aged 5-15 years with CD4 greater than or equal to 500 cells/mm3, according to a study published in the Journal of the Pediatric Infectious Diseases Society.

Investigators at Case Western Reserve University, Cleveland found that 24 weeks of 10 mg daily rosuvastatin decreases plasma coenzyme Q10 concentration and increases CoQ10/LDL ratio in HIV-infected patients on antiretroviral therapy.

Researchers from the University of California, San Francisco, and Yale University, New Haven, Conn., found that half of people newly infected with HIV experience neurologic issues that are generally not severe and usually resolve after starting antiretroviral therapy.

A study of HIV-infected individuals in metropolitan Washington identified high prevalence of transmitted drug resistance, regardless of gender. The authors said active surveillance for transmitted drug resistance is needed to guide antiretroviral usage and analyses of risk group contributions to HIV transmission and resistance.

Single-nucleotide polymorphisms in genes encoding the Toll-like receptor 4 (TLR4) and CD14 are independently associated with long-term CD4+ T-cell recovery in HIV-infected individuals after antiretroviral therapy, according to a study in the journal AIDS.

 

 

In HIV/HCV co-infected individuals, the crude incidence of hepatocellular carcinoma increased from 2001 to 2014, while other liver events declined, according to a recent study.

[email protected]

On Twitter @richpizzi

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Study identifies changing trends in PBC incidence, mortality

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A new study has identified a higher mortality rate among males with primary biliary cholangitis (PBC) and a lower sex ratio in disease prevalence than previously thought, according to findings published online in the journal Scientific Reports.

Investigators analyzed inpatient data from 2000 to 2009 for PBC patients in Denmark and in the Italian province of Lombardia. In the Lombardia cohort, 2,970 PBC patients were identified, with a female to male ratio of 2.3:1. In the Denmark population, 722 cases were identified, with a female to male ratio of 4.2:1, reported Dr. Ana Lleo from the Humanitas Clinical and Research Center in Rozzano, Italy, and her coauthors.

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Among the Lombardia patients, survival at 1, 5, and 10 years was significantly higher for females (89%, 95% confidence interval, 88%-91%; 77%, 95% CI, 75%-78%; and 67%, 95% CI, 65%-70%, respectively) than for males (78%, 95% CI, 75%-80%; 55%, 95% CI, 52%-59%; and 47%, 95% CI, 43%-51%, respectively). Findings were similar in the Denmark cohort, with female patients having higher survival rates (survival at 1, 5, and 10 years of 90%, 87%-92%; 73%, 95% CI, 69%-77%; and 60%, 95% CI, 53%-67%, respectively) than males (72%, 95% CI, 63%-79%; 42%, 95% CI, 32%-51%; and 27%, 95% CI, 14%-43%, respectively), the authors reported.

The study findings question long-held beliefs on PBC, the authors said. Hepatologists should be aware that “male PBC patients have higher mortality than [do] their female counterparts, such that close clinical follow-up and checking adherence to therapy are strongly recommended,” Dr. Lleu and colleagues concluded.

Read the full article in Scientific Reports: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872151.

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A new study has identified a higher mortality rate among males with primary biliary cholangitis (PBC) and a lower sex ratio in disease prevalence than previously thought, according to findings published online in the journal Scientific Reports.

Investigators analyzed inpatient data from 2000 to 2009 for PBC patients in Denmark and in the Italian province of Lombardia. In the Lombardia cohort, 2,970 PBC patients were identified, with a female to male ratio of 2.3:1. In the Denmark population, 722 cases were identified, with a female to male ratio of 4.2:1, reported Dr. Ana Lleo from the Humanitas Clinical and Research Center in Rozzano, Italy, and her coauthors.

©Tashatuvango/Thinkstock

Among the Lombardia patients, survival at 1, 5, and 10 years was significantly higher for females (89%, 95% confidence interval, 88%-91%; 77%, 95% CI, 75%-78%; and 67%, 95% CI, 65%-70%, respectively) than for males (78%, 95% CI, 75%-80%; 55%, 95% CI, 52%-59%; and 47%, 95% CI, 43%-51%, respectively). Findings were similar in the Denmark cohort, with female patients having higher survival rates (survival at 1, 5, and 10 years of 90%, 87%-92%; 73%, 95% CI, 69%-77%; and 60%, 95% CI, 53%-67%, respectively) than males (72%, 95% CI, 63%-79%; 42%, 95% CI, 32%-51%; and 27%, 95% CI, 14%-43%, respectively), the authors reported.

The study findings question long-held beliefs on PBC, the authors said. Hepatologists should be aware that “male PBC patients have higher mortality than [do] their female counterparts, such that close clinical follow-up and checking adherence to therapy are strongly recommended,” Dr. Lleu and colleagues concluded.

Read the full article in Scientific Reports: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872151.

[email protected]

A new study has identified a higher mortality rate among males with primary biliary cholangitis (PBC) and a lower sex ratio in disease prevalence than previously thought, according to findings published online in the journal Scientific Reports.

Investigators analyzed inpatient data from 2000 to 2009 for PBC patients in Denmark and in the Italian province of Lombardia. In the Lombardia cohort, 2,970 PBC patients were identified, with a female to male ratio of 2.3:1. In the Denmark population, 722 cases were identified, with a female to male ratio of 4.2:1, reported Dr. Ana Lleo from the Humanitas Clinical and Research Center in Rozzano, Italy, and her coauthors.

©Tashatuvango/Thinkstock

Among the Lombardia patients, survival at 1, 5, and 10 years was significantly higher for females (89%, 95% confidence interval, 88%-91%; 77%, 95% CI, 75%-78%; and 67%, 95% CI, 65%-70%, respectively) than for males (78%, 95% CI, 75%-80%; 55%, 95% CI, 52%-59%; and 47%, 95% CI, 43%-51%, respectively). Findings were similar in the Denmark cohort, with female patients having higher survival rates (survival at 1, 5, and 10 years of 90%, 87%-92%; 73%, 95% CI, 69%-77%; and 60%, 95% CI, 53%-67%, respectively) than males (72%, 95% CI, 63%-79%; 42%, 95% CI, 32%-51%; and 27%, 95% CI, 14%-43%, respectively), the authors reported.

The study findings question long-held beliefs on PBC, the authors said. Hepatologists should be aware that “male PBC patients have higher mortality than [do] their female counterparts, such that close clinical follow-up and checking adherence to therapy are strongly recommended,” Dr. Lleu and colleagues concluded.

Read the full article in Scientific Reports: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872151.

[email protected]

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Low paravalvular leak shown in real-world registry of Sapien 3 recipients

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Low paravalvular leak shown in real-world registry of Sapien 3 recipients

PARIS – The initial report from a large, prospective registry documenting outcomes in recipients of the Edwards Sapien 3 transcatheter aortic valve in real-world clinical practice confirm that the excellent results seen earlier in the rarified, randomized clinical trial setting are routinely reproducible in everyday practice, Dr. Olaf Wendler said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“The big thing with the Sapien 3 is the reduction in paravalvular leakage. Our rate of moderate or severe paravalvular leakage in the registry at 30 days is only 3.1%, with 73.6% of patients having no or only trace paravalvular leakage,” reported Dr. Wendler, professor of cardiothoracic surgery at King’s College Hospital, London.

Dr. Olaf Wendler

The mean gradient improved from 43.8 mm Hg at baseline to 11.7 mm Hg at discharge, while the effective orifice area climbed from 0.72 to 1.67 cm2.

He presented 30-day outcomes from the SOURCE 3 registry for 1,947 recipients of the Edwards Sapien 3 valve during transcatheter aortic valve replacement at 80 European centers in 10 countries. Their average age was 81.6 years. Updates will continue during a planned 5 years of prospective follow-up.

“This will be a very rich dataset for subgroup analyses. We now have a number of procedural variables we can analyze over time. We will have good data to get to better outcomes in terms of how best to perform the procedure if you do it with a Sapien valve,” he explained.

Among the key findings: The lower profile of the Sapien 3 delivery system, compared with earlier iterations of the Sapien valve, enabled 87% of patients in the registry to undergo TAVR via transfemoral access. And, in these 1,695 patients, whose mean logistic EuroSCORE was 17.8, the 30-day rates of all-cause mortality and disabling stroke were just 1.9% and 0.5%, respectively.

“I think there are not many series that have shown better results than these,” Dr. Wendler commented.

The non–transfemoral-access group is a very different, higher surgical risk cohort with lots more comorbid conditions. Their mean logistic EuroSCORE was 21.8. Yet in this group, the 30-day all-cause mortality and disabling stroke rates were still only 4% and 0.8%.

The transfemoral access group had markedly lower rates of life-threatening bleeding (4%), new-onset atrial fibrillation (4.8%), extended ventilation (3.5%), stage 2-3 acute kidney injury (0.8%), plus a 2-day shorter mean hospital length of stay.

Sixty percent of transfemoral access patients had their TAVR done under conscious sedation. These 1,018 patients constitute the largest dataset ever treated using conscious sedation with one valve system. The conscious sedation group had significantly lower baseline rates of carotid artery disease, prior coronary artery bypass graft surgery, and heart failure than did patients who received general anesthesia. At 30 days post-TAVR, the conscious sedation group had significantly lower rates of extended ventilation and postdilatation, and they received less contrast volume than did the general anesthesia group. However, they had a significantly higher incidence of stroke: 1.7%, compared with 0.6% for the general anesthesia group.

“Why that is the case we don’t know at the moment. We need to look into this more in the future,” the surgeon said.

A particularly impressive finding was how well Sapien 3 valve recipients with a low left ventricular ejection fraction have done. For example, 30-day all-cause mortality in the 100 patients with a baseline LVEF below 30% was 3%, not significantly different from the 1.8% rate in the 1,198 subjects with an LVEF greater than 50% or the 2.6% in patients with an LVEF of 30%-50%.

“Three percent all-cause mortality with an ejection fraction below 30% is just remarkable from my point of view,” Dr. Wendler said.

The 778 who didn’t undergo balloon aortic valvuloplasty prior to Sapien 3 implantation did not fare any worse than did those who did in terms of 30-day all-cause mortality or all strokes, but they did have significantly higher rates of life-threatening bleeding and major vascular complications.

The SOURCE 3 registry is sponsored by Edwards Lifesciences. Dr. Wendler serves as a consultant to the company.

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PARIS – The initial report from a large, prospective registry documenting outcomes in recipients of the Edwards Sapien 3 transcatheter aortic valve in real-world clinical practice confirm that the excellent results seen earlier in the rarified, randomized clinical trial setting are routinely reproducible in everyday practice, Dr. Olaf Wendler said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“The big thing with the Sapien 3 is the reduction in paravalvular leakage. Our rate of moderate or severe paravalvular leakage in the registry at 30 days is only 3.1%, with 73.6% of patients having no or only trace paravalvular leakage,” reported Dr. Wendler, professor of cardiothoracic surgery at King’s College Hospital, London.

Dr. Olaf Wendler

The mean gradient improved from 43.8 mm Hg at baseline to 11.7 mm Hg at discharge, while the effective orifice area climbed from 0.72 to 1.67 cm2.

He presented 30-day outcomes from the SOURCE 3 registry for 1,947 recipients of the Edwards Sapien 3 valve during transcatheter aortic valve replacement at 80 European centers in 10 countries. Their average age was 81.6 years. Updates will continue during a planned 5 years of prospective follow-up.

“This will be a very rich dataset for subgroup analyses. We now have a number of procedural variables we can analyze over time. We will have good data to get to better outcomes in terms of how best to perform the procedure if you do it with a Sapien valve,” he explained.

Among the key findings: The lower profile of the Sapien 3 delivery system, compared with earlier iterations of the Sapien valve, enabled 87% of patients in the registry to undergo TAVR via transfemoral access. And, in these 1,695 patients, whose mean logistic EuroSCORE was 17.8, the 30-day rates of all-cause mortality and disabling stroke were just 1.9% and 0.5%, respectively.

“I think there are not many series that have shown better results than these,” Dr. Wendler commented.

The non–transfemoral-access group is a very different, higher surgical risk cohort with lots more comorbid conditions. Their mean logistic EuroSCORE was 21.8. Yet in this group, the 30-day all-cause mortality and disabling stroke rates were still only 4% and 0.8%.

The transfemoral access group had markedly lower rates of life-threatening bleeding (4%), new-onset atrial fibrillation (4.8%), extended ventilation (3.5%), stage 2-3 acute kidney injury (0.8%), plus a 2-day shorter mean hospital length of stay.

Sixty percent of transfemoral access patients had their TAVR done under conscious sedation. These 1,018 patients constitute the largest dataset ever treated using conscious sedation with one valve system. The conscious sedation group had significantly lower baseline rates of carotid artery disease, prior coronary artery bypass graft surgery, and heart failure than did patients who received general anesthesia. At 30 days post-TAVR, the conscious sedation group had significantly lower rates of extended ventilation and postdilatation, and they received less contrast volume than did the general anesthesia group. However, they had a significantly higher incidence of stroke: 1.7%, compared with 0.6% for the general anesthesia group.

“Why that is the case we don’t know at the moment. We need to look into this more in the future,” the surgeon said.

A particularly impressive finding was how well Sapien 3 valve recipients with a low left ventricular ejection fraction have done. For example, 30-day all-cause mortality in the 100 patients with a baseline LVEF below 30% was 3%, not significantly different from the 1.8% rate in the 1,198 subjects with an LVEF greater than 50% or the 2.6% in patients with an LVEF of 30%-50%.

“Three percent all-cause mortality with an ejection fraction below 30% is just remarkable from my point of view,” Dr. Wendler said.

The 778 who didn’t undergo balloon aortic valvuloplasty prior to Sapien 3 implantation did not fare any worse than did those who did in terms of 30-day all-cause mortality or all strokes, but they did have significantly higher rates of life-threatening bleeding and major vascular complications.

The SOURCE 3 registry is sponsored by Edwards Lifesciences. Dr. Wendler serves as a consultant to the company.

[email protected]

PARIS – The initial report from a large, prospective registry documenting outcomes in recipients of the Edwards Sapien 3 transcatheter aortic valve in real-world clinical practice confirm that the excellent results seen earlier in the rarified, randomized clinical trial setting are routinely reproducible in everyday practice, Dr. Olaf Wendler said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“The big thing with the Sapien 3 is the reduction in paravalvular leakage. Our rate of moderate or severe paravalvular leakage in the registry at 30 days is only 3.1%, with 73.6% of patients having no or only trace paravalvular leakage,” reported Dr. Wendler, professor of cardiothoracic surgery at King’s College Hospital, London.

Dr. Olaf Wendler

The mean gradient improved from 43.8 mm Hg at baseline to 11.7 mm Hg at discharge, while the effective orifice area climbed from 0.72 to 1.67 cm2.

He presented 30-day outcomes from the SOURCE 3 registry for 1,947 recipients of the Edwards Sapien 3 valve during transcatheter aortic valve replacement at 80 European centers in 10 countries. Their average age was 81.6 years. Updates will continue during a planned 5 years of prospective follow-up.

“This will be a very rich dataset for subgroup analyses. We now have a number of procedural variables we can analyze over time. We will have good data to get to better outcomes in terms of how best to perform the procedure if you do it with a Sapien valve,” he explained.

Among the key findings: The lower profile of the Sapien 3 delivery system, compared with earlier iterations of the Sapien valve, enabled 87% of patients in the registry to undergo TAVR via transfemoral access. And, in these 1,695 patients, whose mean logistic EuroSCORE was 17.8, the 30-day rates of all-cause mortality and disabling stroke were just 1.9% and 0.5%, respectively.

“I think there are not many series that have shown better results than these,” Dr. Wendler commented.

The non–transfemoral-access group is a very different, higher surgical risk cohort with lots more comorbid conditions. Their mean logistic EuroSCORE was 21.8. Yet in this group, the 30-day all-cause mortality and disabling stroke rates were still only 4% and 0.8%.

The transfemoral access group had markedly lower rates of life-threatening bleeding (4%), new-onset atrial fibrillation (4.8%), extended ventilation (3.5%), stage 2-3 acute kidney injury (0.8%), plus a 2-day shorter mean hospital length of stay.

Sixty percent of transfemoral access patients had their TAVR done under conscious sedation. These 1,018 patients constitute the largest dataset ever treated using conscious sedation with one valve system. The conscious sedation group had significantly lower baseline rates of carotid artery disease, prior coronary artery bypass graft surgery, and heart failure than did patients who received general anesthesia. At 30 days post-TAVR, the conscious sedation group had significantly lower rates of extended ventilation and postdilatation, and they received less contrast volume than did the general anesthesia group. However, they had a significantly higher incidence of stroke: 1.7%, compared with 0.6% for the general anesthesia group.

“Why that is the case we don’t know at the moment. We need to look into this more in the future,” the surgeon said.

A particularly impressive finding was how well Sapien 3 valve recipients with a low left ventricular ejection fraction have done. For example, 30-day all-cause mortality in the 100 patients with a baseline LVEF below 30% was 3%, not significantly different from the 1.8% rate in the 1,198 subjects with an LVEF greater than 50% or the 2.6% in patients with an LVEF of 30%-50%.

“Three percent all-cause mortality with an ejection fraction below 30% is just remarkable from my point of view,” Dr. Wendler said.

The 778 who didn’t undergo balloon aortic valvuloplasty prior to Sapien 3 implantation did not fare any worse than did those who did in terms of 30-day all-cause mortality or all strokes, but they did have significantly higher rates of life-threatening bleeding and major vascular complications.

The SOURCE 3 registry is sponsored by Edwards Lifesciences. Dr. Wendler serves as a consultant to the company.

[email protected]

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Key clinical point: Only 3.1% of patients had moderate or severe paravalvular leak at 30 days after TAVR with the Sapien 3.

Major finding: The 30-day, all-cause mortality and disabling stroke rates were 1.9% and 0.5% in Sapien 3 valve recipients whose transcatheter aortic valve replacement was done by the transfemoral route.

Data source: A prospective multicenter European registry which includes 1,947 patients who underwent transcatheter aortic valve replacement with the Edwards Sapien 3 valve in real-world commercial settings.

Disclosures: The SOURCE 3 registry is sponsored by Edwards Lifesciences. Dr. Wendler serves as a consultant to the company.

VIDEO: Depression worsens newly diagnosed juvenile idiopathic arthritis

JIA patients need psychological support
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VIDEO: Depression worsens newly diagnosed juvenile idiopathic arthritis

LONDON – Depression is relatively common among teenagers newly diagnosed with juvenile idiopathic arthritis, and adolescents with both disorders appeared to have a less complete response to their treatment in a study of 102 patients.

Juvenile idiopathic arthritis (JIA) that first manifests when a patient is a teenager comes at a “vulnerable time” that can drive the development and worsening of depression, and depression can potentially exacerbate inflammation and also interfere with treatment compliance, Dr. John Ioannou said at the European Congress of Rheumatology,

Depression and JIA can produce a “vicious cycle in which depression exacerbates the disease and the disease exacerbates depression,” explained Dr. Ioannou, a rheumatologist at University College Hospital in London.

Although no study results have yet identified an effective intervention for depression identified in teenagers with newly diagnosed JIA, the immediate message from these new findings is that clinicians must assess the psychological health of adolescents with JIA both when they are first diagnosed as well as at subsequent visits, and if depression is found it requires some sort of intervention, Dr. Ioannou said in an interview.

He and his associates studied 102 patients from the United Kingdom, who were newly diagnosed with JIA and were 11-16 years old at baseline and enrolled in the Childhood Arthritis Prospective Study (CAPS), a nationwide cohort of patients with childhood-onset arthritis of various types. The average age of the group they studied was just under 13 years old, 57% were girls, 52% had persistent oligoarticular arthritis, 30% had polyarticular arthritis, and 18% had enthesitis-related arthritis. All patients underwent assessment at baseline for depression using the Mood and Feelings Questionnaire and 15 (15%) had a score that flagged them as having “probable” depression.

This depression prevalence is about three- to fourfold higher than for an otherwise healthy group of similarly aged adolescents, Dr. Ioannou said.

At baseline, the subgroup of teens with depression had a significantly higher number of inflamed joints, restricted joints, and also more overall pain and disability as measured on the Childhood Health Assessment Questionnaire.

The 102 teens with JIA underwent follow-up assessment 1-3 years later, after they had received ongoing treatment for their JIA. At follow-up, standard JIA treatment had largely resulted in resolution of joint inflammation and movement restriction among all patients, including those with depression at baseline. However the adolescents who had both JIA and depression at entry continued to have significantly more pain and disability at follow-up than did the nondepressed JIA patients, suggesting a link between depression and refractory pain and disability in JIA patients, the researchers reported.

“We need to ensure that psychological assessments and support are available to all young people diagnosed with JIA, and that this is fully integrated into routine care” for newly diagnosed JIA patients, Dr. Ioannou said. He had no disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

On Twitter @mitchelzoler

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Body

Prior study results showed that about a third of adult patients with rheumatoid arthritis are depressed. There seems to be a vulnerability to depression among patients diagnosed with inflammatory arthritis. It makes sense that chronic arthritis can cause depression as it is a painful, debilitating, and long-term disease that is often nonremitting.

Mitchel L. Zoler/Frontline Medical News

Susan Barlett, Ph.D.

Good evidence also suggests that people who are depressed are more vulnerable to develop rheumatoid arthritis or other autoimmune diseases.

The important new findings reported by Dr. Ioannou and his associates underscore the importance of providing psychological support to adolescents newly diagnosed with juvenile idiopathic arthritis. Among its many effects, depression is one of the few robust predictors of nonadherence to medical treatments by patients. Patients who are depressed are less likely to take their medications as prescribed. Depressed patients are also more likely to smoke because tobacco smoking can produce some depression relief. But smoking also contributes to the development and worsening of rheumatoid arthritis and likely other forms of inflammatory arthritis.

Susan Bartlett, Ph.D., is a psychologist and clinical epidemiologist at McGill University, Montreal, who specializes in chronic diseases including arthritis. She had no disclosures. She made these comments during a press conference.

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Prior study results showed that about a third of adult patients with rheumatoid arthritis are depressed. There seems to be a vulnerability to depression among patients diagnosed with inflammatory arthritis. It makes sense that chronic arthritis can cause depression as it is a painful, debilitating, and long-term disease that is often nonremitting.

Mitchel L. Zoler/Frontline Medical News

Susan Barlett, Ph.D.

Good evidence also suggests that people who are depressed are more vulnerable to develop rheumatoid arthritis or other autoimmune diseases.

The important new findings reported by Dr. Ioannou and his associates underscore the importance of providing psychological support to adolescents newly diagnosed with juvenile idiopathic arthritis. Among its many effects, depression is one of the few robust predictors of nonadherence to medical treatments by patients. Patients who are depressed are less likely to take their medications as prescribed. Depressed patients are also more likely to smoke because tobacco smoking can produce some depression relief. But smoking also contributes to the development and worsening of rheumatoid arthritis and likely other forms of inflammatory arthritis.

Susan Bartlett, Ph.D., is a psychologist and clinical epidemiologist at McGill University, Montreal, who specializes in chronic diseases including arthritis. She had no disclosures. She made these comments during a press conference.

Body

Prior study results showed that about a third of adult patients with rheumatoid arthritis are depressed. There seems to be a vulnerability to depression among patients diagnosed with inflammatory arthritis. It makes sense that chronic arthritis can cause depression as it is a painful, debilitating, and long-term disease that is often nonremitting.

Mitchel L. Zoler/Frontline Medical News

Susan Barlett, Ph.D.

Good evidence also suggests that people who are depressed are more vulnerable to develop rheumatoid arthritis or other autoimmune diseases.

The important new findings reported by Dr. Ioannou and his associates underscore the importance of providing psychological support to adolescents newly diagnosed with juvenile idiopathic arthritis. Among its many effects, depression is one of the few robust predictors of nonadherence to medical treatments by patients. Patients who are depressed are less likely to take their medications as prescribed. Depressed patients are also more likely to smoke because tobacco smoking can produce some depression relief. But smoking also contributes to the development and worsening of rheumatoid arthritis and likely other forms of inflammatory arthritis.

Susan Bartlett, Ph.D., is a psychologist and clinical epidemiologist at McGill University, Montreal, who specializes in chronic diseases including arthritis. She had no disclosures. She made these comments during a press conference.

Title
JIA patients need psychological support
JIA patients need psychological support

LONDON – Depression is relatively common among teenagers newly diagnosed with juvenile idiopathic arthritis, and adolescents with both disorders appeared to have a less complete response to their treatment in a study of 102 patients.

Juvenile idiopathic arthritis (JIA) that first manifests when a patient is a teenager comes at a “vulnerable time” that can drive the development and worsening of depression, and depression can potentially exacerbate inflammation and also interfere with treatment compliance, Dr. John Ioannou said at the European Congress of Rheumatology,

Depression and JIA can produce a “vicious cycle in which depression exacerbates the disease and the disease exacerbates depression,” explained Dr. Ioannou, a rheumatologist at University College Hospital in London.

Although no study results have yet identified an effective intervention for depression identified in teenagers with newly diagnosed JIA, the immediate message from these new findings is that clinicians must assess the psychological health of adolescents with JIA both when they are first diagnosed as well as at subsequent visits, and if depression is found it requires some sort of intervention, Dr. Ioannou said in an interview.

He and his associates studied 102 patients from the United Kingdom, who were newly diagnosed with JIA and were 11-16 years old at baseline and enrolled in the Childhood Arthritis Prospective Study (CAPS), a nationwide cohort of patients with childhood-onset arthritis of various types. The average age of the group they studied was just under 13 years old, 57% were girls, 52% had persistent oligoarticular arthritis, 30% had polyarticular arthritis, and 18% had enthesitis-related arthritis. All patients underwent assessment at baseline for depression using the Mood and Feelings Questionnaire and 15 (15%) had a score that flagged them as having “probable” depression.

This depression prevalence is about three- to fourfold higher than for an otherwise healthy group of similarly aged adolescents, Dr. Ioannou said.

At baseline, the subgroup of teens with depression had a significantly higher number of inflamed joints, restricted joints, and also more overall pain and disability as measured on the Childhood Health Assessment Questionnaire.

The 102 teens with JIA underwent follow-up assessment 1-3 years later, after they had received ongoing treatment for their JIA. At follow-up, standard JIA treatment had largely resulted in resolution of joint inflammation and movement restriction among all patients, including those with depression at baseline. However the adolescents who had both JIA and depression at entry continued to have significantly more pain and disability at follow-up than did the nondepressed JIA patients, suggesting a link between depression and refractory pain and disability in JIA patients, the researchers reported.

“We need to ensure that psychological assessments and support are available to all young people diagnosed with JIA, and that this is fully integrated into routine care” for newly diagnosed JIA patients, Dr. Ioannou said. He had no disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

On Twitter @mitchelzoler

LONDON – Depression is relatively common among teenagers newly diagnosed with juvenile idiopathic arthritis, and adolescents with both disorders appeared to have a less complete response to their treatment in a study of 102 patients.

Juvenile idiopathic arthritis (JIA) that first manifests when a patient is a teenager comes at a “vulnerable time” that can drive the development and worsening of depression, and depression can potentially exacerbate inflammation and also interfere with treatment compliance, Dr. John Ioannou said at the European Congress of Rheumatology,

Depression and JIA can produce a “vicious cycle in which depression exacerbates the disease and the disease exacerbates depression,” explained Dr. Ioannou, a rheumatologist at University College Hospital in London.

Although no study results have yet identified an effective intervention for depression identified in teenagers with newly diagnosed JIA, the immediate message from these new findings is that clinicians must assess the psychological health of adolescents with JIA both when they are first diagnosed as well as at subsequent visits, and if depression is found it requires some sort of intervention, Dr. Ioannou said in an interview.

He and his associates studied 102 patients from the United Kingdom, who were newly diagnosed with JIA and were 11-16 years old at baseline and enrolled in the Childhood Arthritis Prospective Study (CAPS), a nationwide cohort of patients with childhood-onset arthritis of various types. The average age of the group they studied was just under 13 years old, 57% were girls, 52% had persistent oligoarticular arthritis, 30% had polyarticular arthritis, and 18% had enthesitis-related arthritis. All patients underwent assessment at baseline for depression using the Mood and Feelings Questionnaire and 15 (15%) had a score that flagged them as having “probable” depression.

This depression prevalence is about three- to fourfold higher than for an otherwise healthy group of similarly aged adolescents, Dr. Ioannou said.

At baseline, the subgroup of teens with depression had a significantly higher number of inflamed joints, restricted joints, and also more overall pain and disability as measured on the Childhood Health Assessment Questionnaire.

The 102 teens with JIA underwent follow-up assessment 1-3 years later, after they had received ongoing treatment for their JIA. At follow-up, standard JIA treatment had largely resulted in resolution of joint inflammation and movement restriction among all patients, including those with depression at baseline. However the adolescents who had both JIA and depression at entry continued to have significantly more pain and disability at follow-up than did the nondepressed JIA patients, suggesting a link between depression and refractory pain and disability in JIA patients, the researchers reported.

“We need to ensure that psychological assessments and support are available to all young people diagnosed with JIA, and that this is fully integrated into routine care” for newly diagnosed JIA patients, Dr. Ioannou said. He had no disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

On Twitter @mitchelzoler

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Key clinical point: Pain and disability often persist despite effective antirheumatic treatment in depressed adolescents with juvenile idiopathic arthritis.

Major finding: Disability and pain levels remained significantly elevated among JIA teens with depression, compared with JIA teens without baseline depression.

Data source: The 102 adolescents enrolled in the Childhood Arthritis Prospective Study with juvenile idiopathic arthritis, including 15 patients with depression at baseline.

Disclosures: Dr. Ioannou had no disclosures.

Artificial pancreas can improve inpatient glycemic control in type 2 diabetes

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NEW ORLEANS – Having people with type 2 diabetes mellitus use an artificial pancreas during hospitalization has the potential to improve control of their glycemia when compared with conventional insulin therapy, based on the results of a small study of inpatients in the United Kingdom.

“This is the first study to show that automated subcutaneous closed-loop insulin delivery without meal-time insulin is feasible and safe in patients with insulin-treated type 2 diabetes in the general wards,” Dr. Hood Thabit of the University of Cambridge (England) reported at the ADA annual scientific sessions. “Closed-loop [delivery] increased time in target, with reduced glucose variability and reduced time spent hyperglycemic without actually increasing time spent hypoglycemic,” he said.

The study involved 40 general ward inpatients evenly assigned to the closed-loop system and conventional insulin therapy for 72 hours.

Dr. Hood Thabit

Dr. Thabit said hyperglycemia in hospital patients is a common problem that’s poorly managed. “There’s an unmet need for an effective and safe glucose control, specifically in the underserved and understudied population of type 2 diabetes in the general wards,” he said. The use of the closed-loop system in inpatients with type 2 diabetes “remains untested until now,” Dr. Thabit added.

The 20 patients randomized to the closed-loop system spent an average of 61% of the whole study period within the sensor glucose target vs. 38% of those on conventional insulin therapy. The closed-loop patients also used comparable insulin daily on average: 62.6 U (±36.3 U) vs. 66.0 U (±39.6 U), Dr. Thabit said.

He noted that those on the closed-loop system did not have to announce meals to the control algorithm, or give any meal-time insulin – “we didn’t want to trouble our nurses with this, due to the increasing workload that health care professionals in the hospital currently face,” he said – and showed “significantly improved” nighttime control of glucose while “simultaneously reducing the risk of nocturnal hypoglycemia”. “The closed loop may potentially be an effective and safe tool to manage hospital inpatient hyperglycemia in this particularly underserved population of patients whilst easing the burden of health care professionals in hospital,” he said.

The cost is not insignificant. The pump and sensor devices together with related consumables can cost up to £6,000 (about $8,600), but he did note the artificial pancreas device itself is reusable. The cost of the automated closed-loop glucose control system can also potentially be offset by the reduced time of health care professionals spent managing inpatient hyperglycemia safely. The study investigators are in the process of planning a larger trial, Dr. Thabit said.

Dr. Thabit had no financial disclosures. Some coauthors disclosed relationships with Novo Nordisk; Medtronic MiniMed; Becton, Dickinson and Co.; Abbott Diabetes Care; Roche Pharmaceuticals; Cell Novo; Animas; Eli Lilly; B. Braun Melsungen; Sanofi-Aventis Deutschland; and Profil Institute for Clinical Research.

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NEW ORLEANS – Having people with type 2 diabetes mellitus use an artificial pancreas during hospitalization has the potential to improve control of their glycemia when compared with conventional insulin therapy, based on the results of a small study of inpatients in the United Kingdom.

“This is the first study to show that automated subcutaneous closed-loop insulin delivery without meal-time insulin is feasible and safe in patients with insulin-treated type 2 diabetes in the general wards,” Dr. Hood Thabit of the University of Cambridge (England) reported at the ADA annual scientific sessions. “Closed-loop [delivery] increased time in target, with reduced glucose variability and reduced time spent hyperglycemic without actually increasing time spent hypoglycemic,” he said.

The study involved 40 general ward inpatients evenly assigned to the closed-loop system and conventional insulin therapy for 72 hours.

Dr. Hood Thabit

Dr. Thabit said hyperglycemia in hospital patients is a common problem that’s poorly managed. “There’s an unmet need for an effective and safe glucose control, specifically in the underserved and understudied population of type 2 diabetes in the general wards,” he said. The use of the closed-loop system in inpatients with type 2 diabetes “remains untested until now,” Dr. Thabit added.

The 20 patients randomized to the closed-loop system spent an average of 61% of the whole study period within the sensor glucose target vs. 38% of those on conventional insulin therapy. The closed-loop patients also used comparable insulin daily on average: 62.6 U (±36.3 U) vs. 66.0 U (±39.6 U), Dr. Thabit said.

He noted that those on the closed-loop system did not have to announce meals to the control algorithm, or give any meal-time insulin – “we didn’t want to trouble our nurses with this, due to the increasing workload that health care professionals in the hospital currently face,” he said – and showed “significantly improved” nighttime control of glucose while “simultaneously reducing the risk of nocturnal hypoglycemia”. “The closed loop may potentially be an effective and safe tool to manage hospital inpatient hyperglycemia in this particularly underserved population of patients whilst easing the burden of health care professionals in hospital,” he said.

The cost is not insignificant. The pump and sensor devices together with related consumables can cost up to £6,000 (about $8,600), but he did note the artificial pancreas device itself is reusable. The cost of the automated closed-loop glucose control system can also potentially be offset by the reduced time of health care professionals spent managing inpatient hyperglycemia safely. The study investigators are in the process of planning a larger trial, Dr. Thabit said.

Dr. Thabit had no financial disclosures. Some coauthors disclosed relationships with Novo Nordisk; Medtronic MiniMed; Becton, Dickinson and Co.; Abbott Diabetes Care; Roche Pharmaceuticals; Cell Novo; Animas; Eli Lilly; B. Braun Melsungen; Sanofi-Aventis Deutschland; and Profil Institute for Clinical Research.

NEW ORLEANS – Having people with type 2 diabetes mellitus use an artificial pancreas during hospitalization has the potential to improve control of their glycemia when compared with conventional insulin therapy, based on the results of a small study of inpatients in the United Kingdom.

“This is the first study to show that automated subcutaneous closed-loop insulin delivery without meal-time insulin is feasible and safe in patients with insulin-treated type 2 diabetes in the general wards,” Dr. Hood Thabit of the University of Cambridge (England) reported at the ADA annual scientific sessions. “Closed-loop [delivery] increased time in target, with reduced glucose variability and reduced time spent hyperglycemic without actually increasing time spent hypoglycemic,” he said.

The study involved 40 general ward inpatients evenly assigned to the closed-loop system and conventional insulin therapy for 72 hours.

Dr. Hood Thabit

Dr. Thabit said hyperglycemia in hospital patients is a common problem that’s poorly managed. “There’s an unmet need for an effective and safe glucose control, specifically in the underserved and understudied population of type 2 diabetes in the general wards,” he said. The use of the closed-loop system in inpatients with type 2 diabetes “remains untested until now,” Dr. Thabit added.

The 20 patients randomized to the closed-loop system spent an average of 61% of the whole study period within the sensor glucose target vs. 38% of those on conventional insulin therapy. The closed-loop patients also used comparable insulin daily on average: 62.6 U (±36.3 U) vs. 66.0 U (±39.6 U), Dr. Thabit said.

He noted that those on the closed-loop system did not have to announce meals to the control algorithm, or give any meal-time insulin – “we didn’t want to trouble our nurses with this, due to the increasing workload that health care professionals in the hospital currently face,” he said – and showed “significantly improved” nighttime control of glucose while “simultaneously reducing the risk of nocturnal hypoglycemia”. “The closed loop may potentially be an effective and safe tool to manage hospital inpatient hyperglycemia in this particularly underserved population of patients whilst easing the burden of health care professionals in hospital,” he said.

The cost is not insignificant. The pump and sensor devices together with related consumables can cost up to £6,000 (about $8,600), but he did note the artificial pancreas device itself is reusable. The cost of the automated closed-loop glucose control system can also potentially be offset by the reduced time of health care professionals spent managing inpatient hyperglycemia safely. The study investigators are in the process of planning a larger trial, Dr. Thabit said.

Dr. Thabit had no financial disclosures. Some coauthors disclosed relationships with Novo Nordisk; Medtronic MiniMed; Becton, Dickinson and Co.; Abbott Diabetes Care; Roche Pharmaceuticals; Cell Novo; Animas; Eli Lilly; B. Braun Melsungen; Sanofi-Aventis Deutschland; and Profil Institute for Clinical Research.

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Key clinical point:Hospitalized patients in the general ward with type 2 diabetes mellitus can maintain better glycemic control by using an artificial pancreas than by taking conventional therapy.

Major finding: Patients on the closed-loop system spent an average of 61% of the study period within the sensor glucose target vs. 38% for those on conventional insulin therapy.

Data source: A single-center study of 40 patients randomized to wear the artificial pancreas or take conventional therapy.

Disclosures: Dr. Thabit had no financial disclosures. Some coauthors disclosed relationships with Novo Nordisk; Medtronic MiniMed; Becton, Dickinson and Co.; Abbott Diabetes Care; Roche Pharmaceuticals; Cell Novo; Animas; Eli Lilly; B. Braun Melsungen; Sanofi-Aventis Deutschland; and Profil Institute for Clinical Research.

AAP, NASPAG issue joint guidance on menstruation management in teens with disabilities

Don’t forget to discuss sexual abuse, sexual intimacy when treating teens with disabilities
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AAP, NASPAG issue joint guidance on menstruation management in teens with disabilities

For the first time, the American Academy of Pediatrics is offering guidance on managing menstruation and sexuality education in adolescents with disabilities.

Written jointly with the North American Society for Pediatric and Adolescent Gynecology, the clinical report offers guidance on options for menstrual management, sexual education and expression, and protection from sexual abuse. The report gives guidance regarding the care of adolescents with physical and/or intellectual abilities, but not for those with psychiatric illnesses (Pediatrics. 2016 April. doi: 10.1542/peds.2016-0295).

“Taking care of teens with disabilities and figuring out what to do with menstrual management has been all over the map,” Dr. Cora Collette Breuner, chair of the AAP’s committee on adolescence, said in an interview. “So, we tried to clarify it and help clinicians know what to do and when.”

Dr. Cora Collette Breuner

A particular concern for the two groups was the threat of adverse events. “We wanted to cover what’s safe and what’s not in menstruation management, especially around bone health and thromboembolic events,” said Dr. Breuner, a professor of pediatrics and adolescent medicine at the University of Washington, Seattle.

Some of the information will not surprise clinicians, but there are some data that will perhaps come as news, said Dr. Breuner, including the recommendation that long-acting reversible contraception (LARC), such as the levonorgestrel intrauterine device or the progesterone implant rod should be considered first-line management therapies. “We point out that a number of studies show that these are safe.”

The report emphasizes offering anticipatory guidance before menses begins, noting that most teens with disabilities mature at the same rate as teens without disabilities. The report does not recommend premenarchal suppression in these patients, because doing so can interfere with normal bone growth. Such suppression also prevents patients and their families and caregivers from discovering that coping with the onset of menses is perhaps not as difficult as they might fear, the report states.

Although combined oral contraceptives are not contraindicated in teens with mobility issues, to guard against the threat of thromboembolic events in teens who use wheelchairs, the report recommends taking a thorough family history to rule out inherited thrombophilia. Otherwise, the recommendation is to prescribe the lowest-dose estrogen with a first- or second-generation progestin, as these are associated with lower rates of venous thrombotic events.

The guidance states that if cycles are creating difficulties in the patient’s life, “as determined by health care providers, patients, and families,” then menstrual management is appropriate. Even though it may take up to 3 years before a menstrual cycle becomes regular, the report cites irregularities caused by certain medications can be reason enough for menstrual management. Specific drugs noted include those affecting the dopaminergic system, valproic acid, and medications that elevate prolactin. Teens with obesity, seizure disorders, and polycystic ovary syndrome also can experience higher rates of irregularity.

The report also warns against the assumption that teens with disabilities are asexual or uninterested in sex. When appropriate, they should be offered the same confidential conversations about sexuality as are recommended for all teenagers by the AAP and the American College of Obstetricians and Gynecologists. “Teenagers with physical disabilities are just as likely to be sexually active as their peers and have a higher incidence of sexual abuse,” the report states. It is typically when a patient is cognitively impaired that consent to confidential services may require “discussion about legal guardianship or medical power of attorney status for families,” according to the report.

The report’s comprehensive review of four main menstrual management techniques – estrogen-containing, progestin-only, nonhormonal methods, and surgical requests and options – begins with the caveat that regardless of the method used, the threat of abuse or sexually transmitted infections remain. When a patient’s family or caregivers request suppression of menarche in a patient, stating fears of abuse or pregnancy, further investigation into the patient’s circumstances is warranted, the report states.

“It’s always worth reminding physicians that in this cohort, endometrial ablation can have legal implications, and it’s not recommended in this age group,” Dr. Breuner said.

On average, 1.5 hormonal methods are tried before achieving management goals, according to the report. Data cited in the study showed that at 42%, oral contraception is the preferred method of menstrual suppression, followed by the patch at 20%. Expectant management was third at 15%, followed by DMPA (depot medroxyprogesterone acetate) at 12%. The least utilized method was the levonorgestrel intrauterine device at 3%. No data were provided for the implantable contraceptive rod.

The clinical report is a companion document to another AAP clinical report, “Sexuality of Children and Adolescents with Developmental Disabilities” (Pediatrics. 2006. doi: 10.1542/peds.2006-1115).

 

 

AAP guidance on these matters in teens with psychiatric illnesses is expected to be issued within a few years, Dr. Breuner said.

There was no external funding and the authors have no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

References

Body

Although this guideline focuses on menstrual management and the guidance for you to help teens with disabilities through the pubertal transition, it’s very important to put this topic also into the context of sexuality. I think you have a great opportunity to do this because, often, you already have developed long-term relationships with these teenagers and their families, so the trust is already there. You should be the one to ensure all patients have appropriate sex education and help families with this.


Dr. Elisabeth Quint

For some of these teens who are cognitively impaired, the initial conversations about sex may focus more on safety and abuse prevention. For example, which parts of their body should not be touched by other people. You can help the families really be the educators. Parents can be the ones to teach their kids how to protect themselves by rehearsing the answers to questions like, “What do you do if someone touches you? Who do you tell? Where do you go? What if it happens at school?” As part of the safety aspects, you also can help families assess whether the patient will be able to have a consensual sexual relationship. It’s the teens who have mild cognitive impairment that I worry about most, because often they are friendly and open to people, and can be taken advantage of. You just want to make sure they have the right information at their appropriate level.

Adolescents with physical disabilities are going to be just as interested in sex as any other teens and should be helped with any potential issues that they may have around that issue. They will likely get sex education in schools, but are still often viewed as not interested in sex or sexually active, and they may not get the usual confidential teen questions or appropriate screenings. Menstrual management and sexuality education both are important aspects of reproductive health care for teens with disabilities.

Dr. Elisabeth Quint, lead author of the AAP clinical report “Menstrual Management for Adolescents,” is a clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor. She is also a past president of the North American Society for Pediatric and Adolescent Gynecology.

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Body

Although this guideline focuses on menstrual management and the guidance for you to help teens with disabilities through the pubertal transition, it’s very important to put this topic also into the context of sexuality. I think you have a great opportunity to do this because, often, you already have developed long-term relationships with these teenagers and their families, so the trust is already there. You should be the one to ensure all patients have appropriate sex education and help families with this.


Dr. Elisabeth Quint

For some of these teens who are cognitively impaired, the initial conversations about sex may focus more on safety and abuse prevention. For example, which parts of their body should not be touched by other people. You can help the families really be the educators. Parents can be the ones to teach their kids how to protect themselves by rehearsing the answers to questions like, “What do you do if someone touches you? Who do you tell? Where do you go? What if it happens at school?” As part of the safety aspects, you also can help families assess whether the patient will be able to have a consensual sexual relationship. It’s the teens who have mild cognitive impairment that I worry about most, because often they are friendly and open to people, and can be taken advantage of. You just want to make sure they have the right information at their appropriate level.

Adolescents with physical disabilities are going to be just as interested in sex as any other teens and should be helped with any potential issues that they may have around that issue. They will likely get sex education in schools, but are still often viewed as not interested in sex or sexually active, and they may not get the usual confidential teen questions or appropriate screenings. Menstrual management and sexuality education both are important aspects of reproductive health care for teens with disabilities.

Dr. Elisabeth Quint, lead author of the AAP clinical report “Menstrual Management for Adolescents,” is a clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor. She is also a past president of the North American Society for Pediatric and Adolescent Gynecology.

Body

Although this guideline focuses on menstrual management and the guidance for you to help teens with disabilities through the pubertal transition, it’s very important to put this topic also into the context of sexuality. I think you have a great opportunity to do this because, often, you already have developed long-term relationships with these teenagers and their families, so the trust is already there. You should be the one to ensure all patients have appropriate sex education and help families with this.


Dr. Elisabeth Quint

For some of these teens who are cognitively impaired, the initial conversations about sex may focus more on safety and abuse prevention. For example, which parts of their body should not be touched by other people. You can help the families really be the educators. Parents can be the ones to teach their kids how to protect themselves by rehearsing the answers to questions like, “What do you do if someone touches you? Who do you tell? Where do you go? What if it happens at school?” As part of the safety aspects, you also can help families assess whether the patient will be able to have a consensual sexual relationship. It’s the teens who have mild cognitive impairment that I worry about most, because often they are friendly and open to people, and can be taken advantage of. You just want to make sure they have the right information at their appropriate level.

Adolescents with physical disabilities are going to be just as interested in sex as any other teens and should be helped with any potential issues that they may have around that issue. They will likely get sex education in schools, but are still often viewed as not interested in sex or sexually active, and they may not get the usual confidential teen questions or appropriate screenings. Menstrual management and sexuality education both are important aspects of reproductive health care for teens with disabilities.

Dr. Elisabeth Quint, lead author of the AAP clinical report “Menstrual Management for Adolescents,” is a clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor. She is also a past president of the North American Society for Pediatric and Adolescent Gynecology.

Title
Don’t forget to discuss sexual abuse, sexual intimacy when treating teens with disabilities
Don’t forget to discuss sexual abuse, sexual intimacy when treating teens with disabilities

For the first time, the American Academy of Pediatrics is offering guidance on managing menstruation and sexuality education in adolescents with disabilities.

Written jointly with the North American Society for Pediatric and Adolescent Gynecology, the clinical report offers guidance on options for menstrual management, sexual education and expression, and protection from sexual abuse. The report gives guidance regarding the care of adolescents with physical and/or intellectual abilities, but not for those with psychiatric illnesses (Pediatrics. 2016 April. doi: 10.1542/peds.2016-0295).

“Taking care of teens with disabilities and figuring out what to do with menstrual management has been all over the map,” Dr. Cora Collette Breuner, chair of the AAP’s committee on adolescence, said in an interview. “So, we tried to clarify it and help clinicians know what to do and when.”

Dr. Cora Collette Breuner

A particular concern for the two groups was the threat of adverse events. “We wanted to cover what’s safe and what’s not in menstruation management, especially around bone health and thromboembolic events,” said Dr. Breuner, a professor of pediatrics and adolescent medicine at the University of Washington, Seattle.

Some of the information will not surprise clinicians, but there are some data that will perhaps come as news, said Dr. Breuner, including the recommendation that long-acting reversible contraception (LARC), such as the levonorgestrel intrauterine device or the progesterone implant rod should be considered first-line management therapies. “We point out that a number of studies show that these are safe.”

The report emphasizes offering anticipatory guidance before menses begins, noting that most teens with disabilities mature at the same rate as teens without disabilities. The report does not recommend premenarchal suppression in these patients, because doing so can interfere with normal bone growth. Such suppression also prevents patients and their families and caregivers from discovering that coping with the onset of menses is perhaps not as difficult as they might fear, the report states.

Although combined oral contraceptives are not contraindicated in teens with mobility issues, to guard against the threat of thromboembolic events in teens who use wheelchairs, the report recommends taking a thorough family history to rule out inherited thrombophilia. Otherwise, the recommendation is to prescribe the lowest-dose estrogen with a first- or second-generation progestin, as these are associated with lower rates of venous thrombotic events.

The guidance states that if cycles are creating difficulties in the patient’s life, “as determined by health care providers, patients, and families,” then menstrual management is appropriate. Even though it may take up to 3 years before a menstrual cycle becomes regular, the report cites irregularities caused by certain medications can be reason enough for menstrual management. Specific drugs noted include those affecting the dopaminergic system, valproic acid, and medications that elevate prolactin. Teens with obesity, seizure disorders, and polycystic ovary syndrome also can experience higher rates of irregularity.

The report also warns against the assumption that teens with disabilities are asexual or uninterested in sex. When appropriate, they should be offered the same confidential conversations about sexuality as are recommended for all teenagers by the AAP and the American College of Obstetricians and Gynecologists. “Teenagers with physical disabilities are just as likely to be sexually active as their peers and have a higher incidence of sexual abuse,” the report states. It is typically when a patient is cognitively impaired that consent to confidential services may require “discussion about legal guardianship or medical power of attorney status for families,” according to the report.

The report’s comprehensive review of four main menstrual management techniques – estrogen-containing, progestin-only, nonhormonal methods, and surgical requests and options – begins with the caveat that regardless of the method used, the threat of abuse or sexually transmitted infections remain. When a patient’s family or caregivers request suppression of menarche in a patient, stating fears of abuse or pregnancy, further investigation into the patient’s circumstances is warranted, the report states.

“It’s always worth reminding physicians that in this cohort, endometrial ablation can have legal implications, and it’s not recommended in this age group,” Dr. Breuner said.

On average, 1.5 hormonal methods are tried before achieving management goals, according to the report. Data cited in the study showed that at 42%, oral contraception is the preferred method of menstrual suppression, followed by the patch at 20%. Expectant management was third at 15%, followed by DMPA (depot medroxyprogesterone acetate) at 12%. The least utilized method was the levonorgestrel intrauterine device at 3%. No data were provided for the implantable contraceptive rod.

The clinical report is a companion document to another AAP clinical report, “Sexuality of Children and Adolescents with Developmental Disabilities” (Pediatrics. 2006. doi: 10.1542/peds.2006-1115).

 

 

AAP guidance on these matters in teens with psychiatric illnesses is expected to be issued within a few years, Dr. Breuner said.

There was no external funding and the authors have no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

For the first time, the American Academy of Pediatrics is offering guidance on managing menstruation and sexuality education in adolescents with disabilities.

Written jointly with the North American Society for Pediatric and Adolescent Gynecology, the clinical report offers guidance on options for menstrual management, sexual education and expression, and protection from sexual abuse. The report gives guidance regarding the care of adolescents with physical and/or intellectual abilities, but not for those with psychiatric illnesses (Pediatrics. 2016 April. doi: 10.1542/peds.2016-0295).

“Taking care of teens with disabilities and figuring out what to do with menstrual management has been all over the map,” Dr. Cora Collette Breuner, chair of the AAP’s committee on adolescence, said in an interview. “So, we tried to clarify it and help clinicians know what to do and when.”

Dr. Cora Collette Breuner

A particular concern for the two groups was the threat of adverse events. “We wanted to cover what’s safe and what’s not in menstruation management, especially around bone health and thromboembolic events,” said Dr. Breuner, a professor of pediatrics and adolescent medicine at the University of Washington, Seattle.

Some of the information will not surprise clinicians, but there are some data that will perhaps come as news, said Dr. Breuner, including the recommendation that long-acting reversible contraception (LARC), such as the levonorgestrel intrauterine device or the progesterone implant rod should be considered first-line management therapies. “We point out that a number of studies show that these are safe.”

The report emphasizes offering anticipatory guidance before menses begins, noting that most teens with disabilities mature at the same rate as teens without disabilities. The report does not recommend premenarchal suppression in these patients, because doing so can interfere with normal bone growth. Such suppression also prevents patients and their families and caregivers from discovering that coping with the onset of menses is perhaps not as difficult as they might fear, the report states.

Although combined oral contraceptives are not contraindicated in teens with mobility issues, to guard against the threat of thromboembolic events in teens who use wheelchairs, the report recommends taking a thorough family history to rule out inherited thrombophilia. Otherwise, the recommendation is to prescribe the lowest-dose estrogen with a first- or second-generation progestin, as these are associated with lower rates of venous thrombotic events.

The guidance states that if cycles are creating difficulties in the patient’s life, “as determined by health care providers, patients, and families,” then menstrual management is appropriate. Even though it may take up to 3 years before a menstrual cycle becomes regular, the report cites irregularities caused by certain medications can be reason enough for menstrual management. Specific drugs noted include those affecting the dopaminergic system, valproic acid, and medications that elevate prolactin. Teens with obesity, seizure disorders, and polycystic ovary syndrome also can experience higher rates of irregularity.

The report also warns against the assumption that teens with disabilities are asexual or uninterested in sex. When appropriate, they should be offered the same confidential conversations about sexuality as are recommended for all teenagers by the AAP and the American College of Obstetricians and Gynecologists. “Teenagers with physical disabilities are just as likely to be sexually active as their peers and have a higher incidence of sexual abuse,” the report states. It is typically when a patient is cognitively impaired that consent to confidential services may require “discussion about legal guardianship or medical power of attorney status for families,” according to the report.

The report’s comprehensive review of four main menstrual management techniques – estrogen-containing, progestin-only, nonhormonal methods, and surgical requests and options – begins with the caveat that regardless of the method used, the threat of abuse or sexually transmitted infections remain. When a patient’s family or caregivers request suppression of menarche in a patient, stating fears of abuse or pregnancy, further investigation into the patient’s circumstances is warranted, the report states.

“It’s always worth reminding physicians that in this cohort, endometrial ablation can have legal implications, and it’s not recommended in this age group,” Dr. Breuner said.

On average, 1.5 hormonal methods are tried before achieving management goals, according to the report. Data cited in the study showed that at 42%, oral contraception is the preferred method of menstrual suppression, followed by the patch at 20%. Expectant management was third at 15%, followed by DMPA (depot medroxyprogesterone acetate) at 12%. The least utilized method was the levonorgestrel intrauterine device at 3%. No data were provided for the implantable contraceptive rod.

The clinical report is a companion document to another AAP clinical report, “Sexuality of Children and Adolescents with Developmental Disabilities” (Pediatrics. 2006. doi: 10.1542/peds.2006-1115).

 

 

AAP guidance on these matters in teens with psychiatric illnesses is expected to be issued within a few years, Dr. Breuner said.

There was no external funding and the authors have no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

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Consider Fusobacterium in culture-negative pharyngitis

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BOSTON – An underappreciated cause of bacterial pharyngitis had a similar clinical presentation to group A Streptococcus (GAS), although prevalence was low in the population of 300 pediatric patients in a single-site study.

The 10 patients (3.3%) who had positive cultures for Fusobacterium necrophorum were about as likely as those with GAS to have fever, sore throat, exudate, and absence of cough. GAS cultures were positive in 57 (19%) of the patients.

Kari Oakes/Frontline Medical News
Tam Van, Ph.D.

F. necrophorum is a common cause of serious bacterial pharyngitis, especially in adolescents and young adults. The gram-negative species, an obligate anaerobe, is a cause of Lemierre’s syndrome, and “has recently been identified to be an important pathogen of bacterial pharyngitis with higher prevalence than group A Streptococcus (GAS) in adolescents and young adults,” wrote Tam Van, Ph.D., and her colleagues in a poster presented at the annual meeting of the American Society for Microbiology.

To examine the prevalence and disease characteristics of F. necrophorum in the emergency department patient population at Children’s Hospital of Los Angeles, Dr Van, a medical microbiology fellow at the hospital, and her colleagues enrolled 300 patients with pharyngitis aged 1-20 years (mean, 7.8 years).

All patients’ throats were swabbed, and investigators conducted a rapid antigen detection test (RADT) for group A beta-hemolytic Streptococcus and cultured samples for Streptococcus on a blood agar plate, according to usual care; samples also were cultured anaerobically and tested via polymerase chain reaction (PCR) for F. necrophorum.

A total of 67 patients had positive culture or PCR results for both species. Fifteen of the RADT tests were positive, while 57 cultures returned positive for GAS growth. Nine of the 10 positive F. necrophorum PCR tests correlated with positive culture results for that species.

Luckily, said Dr. Van, penicillin is an effective treatment for F. necrophorum, although it’s a gram-negative bacterium, so if a patient is coinfected with F. necrophorum and GAS, or treated for GAS empirically, then standard of care treatment should be effective, she said. However, since the species is associated with serious complications such as Lemierre’s disease, close follow-up and a low threshold for aggressive treatment are warranted if F. necrophorum is suspected or identified.

The relatively low positive culture rate of 3.3% for F. necrophorum in the study population was a bit surprising, Dr. Van said in an interview but was perhaps accounted for by the relatively young age of the Children’s Hospital Los Angeles patients. “Previous reports looked at adolescents and young adults,” wrote Dr. Van and her colleagues, while two-thirds of the patients in their study were under the age of 10 years. “This may contribute to the difference in prevalence.”

“Although rare, recovery of F. necrophorum correlated with true signs and symptoms of bacterial pharyngitis,” wrote Dr. Van and her colleagues. Serious pharyngitis with a negative rapid test and culture for group A Streptococcus should prompt clinical suspicion for F. necrophorum, especially in older adolescents and young adults, said Dr. Tam.

Dr. Tam and her coauthors reported no outside sources of funding and reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

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BOSTON – An underappreciated cause of bacterial pharyngitis had a similar clinical presentation to group A Streptococcus (GAS), although prevalence was low in the population of 300 pediatric patients in a single-site study.

The 10 patients (3.3%) who had positive cultures for Fusobacterium necrophorum were about as likely as those with GAS to have fever, sore throat, exudate, and absence of cough. GAS cultures were positive in 57 (19%) of the patients.

Kari Oakes/Frontline Medical News
Tam Van, Ph.D.

F. necrophorum is a common cause of serious bacterial pharyngitis, especially in adolescents and young adults. The gram-negative species, an obligate anaerobe, is a cause of Lemierre’s syndrome, and “has recently been identified to be an important pathogen of bacterial pharyngitis with higher prevalence than group A Streptococcus (GAS) in adolescents and young adults,” wrote Tam Van, Ph.D., and her colleagues in a poster presented at the annual meeting of the American Society for Microbiology.

To examine the prevalence and disease characteristics of F. necrophorum in the emergency department patient population at Children’s Hospital of Los Angeles, Dr Van, a medical microbiology fellow at the hospital, and her colleagues enrolled 300 patients with pharyngitis aged 1-20 years (mean, 7.8 years).

All patients’ throats were swabbed, and investigators conducted a rapid antigen detection test (RADT) for group A beta-hemolytic Streptococcus and cultured samples for Streptococcus on a blood agar plate, according to usual care; samples also were cultured anaerobically and tested via polymerase chain reaction (PCR) for F. necrophorum.

A total of 67 patients had positive culture or PCR results for both species. Fifteen of the RADT tests were positive, while 57 cultures returned positive for GAS growth. Nine of the 10 positive F. necrophorum PCR tests correlated with positive culture results for that species.

Luckily, said Dr. Van, penicillin is an effective treatment for F. necrophorum, although it’s a gram-negative bacterium, so if a patient is coinfected with F. necrophorum and GAS, or treated for GAS empirically, then standard of care treatment should be effective, she said. However, since the species is associated with serious complications such as Lemierre’s disease, close follow-up and a low threshold for aggressive treatment are warranted if F. necrophorum is suspected or identified.

The relatively low positive culture rate of 3.3% for F. necrophorum in the study population was a bit surprising, Dr. Van said in an interview but was perhaps accounted for by the relatively young age of the Children’s Hospital Los Angeles patients. “Previous reports looked at adolescents and young adults,” wrote Dr. Van and her colleagues, while two-thirds of the patients in their study were under the age of 10 years. “This may contribute to the difference in prevalence.”

“Although rare, recovery of F. necrophorum correlated with true signs and symptoms of bacterial pharyngitis,” wrote Dr. Van and her colleagues. Serious pharyngitis with a negative rapid test and culture for group A Streptococcus should prompt clinical suspicion for F. necrophorum, especially in older adolescents and young adults, said Dr. Tam.

Dr. Tam and her coauthors reported no outside sources of funding and reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BOSTON – An underappreciated cause of bacterial pharyngitis had a similar clinical presentation to group A Streptococcus (GAS), although prevalence was low in the population of 300 pediatric patients in a single-site study.

The 10 patients (3.3%) who had positive cultures for Fusobacterium necrophorum were about as likely as those with GAS to have fever, sore throat, exudate, and absence of cough. GAS cultures were positive in 57 (19%) of the patients.

Kari Oakes/Frontline Medical News
Tam Van, Ph.D.

F. necrophorum is a common cause of serious bacterial pharyngitis, especially in adolescents and young adults. The gram-negative species, an obligate anaerobe, is a cause of Lemierre’s syndrome, and “has recently been identified to be an important pathogen of bacterial pharyngitis with higher prevalence than group A Streptococcus (GAS) in adolescents and young adults,” wrote Tam Van, Ph.D., and her colleagues in a poster presented at the annual meeting of the American Society for Microbiology.

To examine the prevalence and disease characteristics of F. necrophorum in the emergency department patient population at Children’s Hospital of Los Angeles, Dr Van, a medical microbiology fellow at the hospital, and her colleagues enrolled 300 patients with pharyngitis aged 1-20 years (mean, 7.8 years).

All patients’ throats were swabbed, and investigators conducted a rapid antigen detection test (RADT) for group A beta-hemolytic Streptococcus and cultured samples for Streptococcus on a blood agar plate, according to usual care; samples also were cultured anaerobically and tested via polymerase chain reaction (PCR) for F. necrophorum.

A total of 67 patients had positive culture or PCR results for both species. Fifteen of the RADT tests were positive, while 57 cultures returned positive for GAS growth. Nine of the 10 positive F. necrophorum PCR tests correlated with positive culture results for that species.

Luckily, said Dr. Van, penicillin is an effective treatment for F. necrophorum, although it’s a gram-negative bacterium, so if a patient is coinfected with F. necrophorum and GAS, or treated for GAS empirically, then standard of care treatment should be effective, she said. However, since the species is associated with serious complications such as Lemierre’s disease, close follow-up and a low threshold for aggressive treatment are warranted if F. necrophorum is suspected or identified.

The relatively low positive culture rate of 3.3% for F. necrophorum in the study population was a bit surprising, Dr. Van said in an interview but was perhaps accounted for by the relatively young age of the Children’s Hospital Los Angeles patients. “Previous reports looked at adolescents and young adults,” wrote Dr. Van and her colleagues, while two-thirds of the patients in their study were under the age of 10 years. “This may contribute to the difference in prevalence.”

“Although rare, recovery of F. necrophorum correlated with true signs and symptoms of bacterial pharyngitis,” wrote Dr. Van and her colleagues. Serious pharyngitis with a negative rapid test and culture for group A Streptococcus should prompt clinical suspicion for F. necrophorum, especially in older adolescents and young adults, said Dr. Tam.

Dr. Tam and her coauthors reported no outside sources of funding and reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

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Key clinical point: Fusobacterium necrophorum has a similar presentation to group A Streptococcus (GAS) pharyngitis.

Major finding: Pediatric patients with F. necrophorum pharyngitis were about as likely as those with GAS to have fever, exudates, adenopathy, and no cough.

Data source: 300 pediatric emergency department patients with pharyngitis who received antigen testing, cultures, and PCR to identify both causative agents.

Disclosures: The study investigators reported no disclosures.

Debunking Psoriasis Myths: Can Diet Clear Psoriasis?

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Myth: Psoriasis Can Be Treated By Eating or Avoiding Certain Foods

Patients who Google “diet and psoriasis” are flooded with search results of diets claiming to cure psoriasis. This misinformation is dangerous for patients, as there is no scientific evidence that any specific psoriasis diet can treat the condition. Patients may wish to improve their diet to prevent comorbidities such as cardiovascular disease and metabolic syndrome. Even though it may not be a cure, encouraging patients to eat healthy is never a bad thing.

In a 2014 analysis of psoriasis, obesity, body mass index (BMI), and diet literature, an increased risk for psoriasis development in the setting of obesity was discussed. There is evidence suggesting that a BMI greater than 30 kg/m2 may potentially play a role in the ability to achieve a full therapeutic effect of psoriasis therapy. “This could be for two possible reasons,” Debbaneh et al reported. “It may be a consequence of decreased drug distribution into the body due to increased body mass, or it may be a consequence of increased pro-inflammatory cytokine release as a result of increased adipocyte count.” However, this finding may be treatment specific. For example, higher body weight was an independent predictor of response to ustekinumab, providing the rationale for offering 2 weight-based dosing regimens of the drug. Overweight and obese patients also were less likely to experience clearance with adalimumab. However, studies have found no association between BMI and biologic treatment.

Weight loss through a low-calorie diet has been reported to achieve a greater reduction in psoriasis severity and a slower rebound of disease. “Interestingly, studies have shown that caloric restriction in obese subjects lowers the level of circulating inflammatory cytokines,” reported Debbaneh et al. “This may contribute to the observed beneficial effect in psoriatic disease.”

In patients whose disease has had a significant impact on quality of life, it is important that they are consulting resources online that will help them maintain a healthy lifestyle. The National Psoriasis Foundation provides useful information on diet and psoriasis, emphasizing that diet is not going to cure psoriatic disease but eating healthier can only help.

Expert Commentary

Many of my psoriasis patients ask me what should they avoid eating to prevent the psoriasis from worsening, or what did they eat to cause psoriasis to occur in the first place. I stress to patients that what they eat is not likely the cause of their psoriasis nor will avoiding certain foods prevent a flare. However, alcohol use may induce a psoriasis flare.

—Jashin J. Wu, MD (Los Angeles, California)

References

Debbaneh M, Millsop JW, Bhatia BK, et al. Diet and psoriasis: part I. impact of weight loss interventions. J Am Acad Dermatol. 2014;71:133-140.

National Psoriasis Foundation. Diet and psoriasis. https://www.psoriasis.org/about-psoriasis/treatments/alternative/diet-supplements. Accessed June 20, 2016.

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Myth: Psoriasis Can Be Treated By Eating or Avoiding Certain Foods

Patients who Google “diet and psoriasis” are flooded with search results of diets claiming to cure psoriasis. This misinformation is dangerous for patients, as there is no scientific evidence that any specific psoriasis diet can treat the condition. Patients may wish to improve their diet to prevent comorbidities such as cardiovascular disease and metabolic syndrome. Even though it may not be a cure, encouraging patients to eat healthy is never a bad thing.

In a 2014 analysis of psoriasis, obesity, body mass index (BMI), and diet literature, an increased risk for psoriasis development in the setting of obesity was discussed. There is evidence suggesting that a BMI greater than 30 kg/m2 may potentially play a role in the ability to achieve a full therapeutic effect of psoriasis therapy. “This could be for two possible reasons,” Debbaneh et al reported. “It may be a consequence of decreased drug distribution into the body due to increased body mass, or it may be a consequence of increased pro-inflammatory cytokine release as a result of increased adipocyte count.” However, this finding may be treatment specific. For example, higher body weight was an independent predictor of response to ustekinumab, providing the rationale for offering 2 weight-based dosing regimens of the drug. Overweight and obese patients also were less likely to experience clearance with adalimumab. However, studies have found no association between BMI and biologic treatment.

Weight loss through a low-calorie diet has been reported to achieve a greater reduction in psoriasis severity and a slower rebound of disease. “Interestingly, studies have shown that caloric restriction in obese subjects lowers the level of circulating inflammatory cytokines,” reported Debbaneh et al. “This may contribute to the observed beneficial effect in psoriatic disease.”

In patients whose disease has had a significant impact on quality of life, it is important that they are consulting resources online that will help them maintain a healthy lifestyle. The National Psoriasis Foundation provides useful information on diet and psoriasis, emphasizing that diet is not going to cure psoriatic disease but eating healthier can only help.

Expert Commentary

Many of my psoriasis patients ask me what should they avoid eating to prevent the psoriasis from worsening, or what did they eat to cause psoriasis to occur in the first place. I stress to patients that what they eat is not likely the cause of their psoriasis nor will avoiding certain foods prevent a flare. However, alcohol use may induce a psoriasis flare.

—Jashin J. Wu, MD (Los Angeles, California)

Myth: Psoriasis Can Be Treated By Eating or Avoiding Certain Foods

Patients who Google “diet and psoriasis” are flooded with search results of diets claiming to cure psoriasis. This misinformation is dangerous for patients, as there is no scientific evidence that any specific psoriasis diet can treat the condition. Patients may wish to improve their diet to prevent comorbidities such as cardiovascular disease and metabolic syndrome. Even though it may not be a cure, encouraging patients to eat healthy is never a bad thing.

In a 2014 analysis of psoriasis, obesity, body mass index (BMI), and diet literature, an increased risk for psoriasis development in the setting of obesity was discussed. There is evidence suggesting that a BMI greater than 30 kg/m2 may potentially play a role in the ability to achieve a full therapeutic effect of psoriasis therapy. “This could be for two possible reasons,” Debbaneh et al reported. “It may be a consequence of decreased drug distribution into the body due to increased body mass, or it may be a consequence of increased pro-inflammatory cytokine release as a result of increased adipocyte count.” However, this finding may be treatment specific. For example, higher body weight was an independent predictor of response to ustekinumab, providing the rationale for offering 2 weight-based dosing regimens of the drug. Overweight and obese patients also were less likely to experience clearance with adalimumab. However, studies have found no association between BMI and biologic treatment.

Weight loss through a low-calorie diet has been reported to achieve a greater reduction in psoriasis severity and a slower rebound of disease. “Interestingly, studies have shown that caloric restriction in obese subjects lowers the level of circulating inflammatory cytokines,” reported Debbaneh et al. “This may contribute to the observed beneficial effect in psoriatic disease.”

In patients whose disease has had a significant impact on quality of life, it is important that they are consulting resources online that will help them maintain a healthy lifestyle. The National Psoriasis Foundation provides useful information on diet and psoriasis, emphasizing that diet is not going to cure psoriatic disease but eating healthier can only help.

Expert Commentary

Many of my psoriasis patients ask me what should they avoid eating to prevent the psoriasis from worsening, or what did they eat to cause psoriasis to occur in the first place. I stress to patients that what they eat is not likely the cause of their psoriasis nor will avoiding certain foods prevent a flare. However, alcohol use may induce a psoriasis flare.

—Jashin J. Wu, MD (Los Angeles, California)

References

Debbaneh M, Millsop JW, Bhatia BK, et al. Diet and psoriasis: part I. impact of weight loss interventions. J Am Acad Dermatol. 2014;71:133-140.

National Psoriasis Foundation. Diet and psoriasis. https://www.psoriasis.org/about-psoriasis/treatments/alternative/diet-supplements. Accessed June 20, 2016.

References

Debbaneh M, Millsop JW, Bhatia BK, et al. Diet and psoriasis: part I. impact of weight loss interventions. J Am Acad Dermatol. 2014;71:133-140.

National Psoriasis Foundation. Diet and psoriasis. https://www.psoriasis.org/about-psoriasis/treatments/alternative/diet-supplements. Accessed June 20, 2016.

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Challenging ‘dogma’ of allografts in infectious endocarditis

Two commentaries: ‘Reasonable’ conclusions, but questions remain
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Challenging ‘dogma’ of allografts in infectious endocarditis

When a patient undergoes aortic valve replacement for infective endocarditis, conventional thinking holds that cardiac surgeons should use homografts because they have greater resistance to infection, but a recent study of more than 300 cases at two academic medical centers concluded that homografts may not necessarily offer such a benefit.

The study, published in the June issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:1239-48), involved 304 consecutive adult patients on whom 30-40 different surgeons performed operations for active infective endocarditis (IE) in the aortic valve from 2002 to 2014.

©CDC/Janice Haney Carr
Under a very high magnification of 50,000x, this scanning electron micrograph shows a strain of Staphylococcus aureus bacteria taken from a vancomycin intermediate resistant culture.

“Our findings suggest that patient-specific factors, such as age and implant preference, as well as technical reconstructive considerations, should drive prosthetic choice, rather than surgical dogma,” said Joon Bum Kim, Ph.D., of Massachusetts General Hospital, Harvard Medical School, both in Boston, and Asan Medical Center in Seoul, Korea, and his colleagues.

The study found that cardiac surgeons favored homografts over conventional prostheses when the patient had prosthetic valve endocarditis (58.1% vs. 28.8%) and methicillin-resistant Staphylococcus aureus (25.6% vs. 12.1%), both significant differences.

“No significant benefit to the use of homografts was demonstrable with regard to resistance to reinfection in the setting of IE,” Dr. Kim and his colleagues said.

Because reinfection after valve replacement for IE is such a strong concern, the debate over which prosthesis is best has ensued for decades. The researchers pointed out that the evidence favoring autologous or allogeneic tissue over synthetic material in the infective field is weak, mostly built on single-armed observational studies without comparison to conventional prosthesis.

With that in mind, the researchers pooled data from two institutions to compare short- and long-term results for homograft vs. conventional prosthetic valves in patients with IE. In this study group, 86 (28.3%) had homografts, 139 (45.7%) had xenograft prostheses, and 79 (26%) mechanical prostheses. The homograft group had more than twice the rate of early death than did the conventional group – 19.8% vs. 9.2%, a significant difference (P = .019).

During follow-up, which ranged from 4.7 to 72.6 months, 60 patients (19.7%) of the total group died and 23 (7.7%) experienced reinfection, but rates did not vary between the homograft and conventional prosthesis groups, Dr. Kim and his colleagues reported.

Demographics were similar between the three groups with a few exceptions Those who received the mechanical prostheses were younger (mean age, 47.2 years vs. 55.6 and 59.8 for the homograft and xenograft groups, respectively), had lower rates of diabetes (5.1% vs. 10.5% and 12.2%) and had less-severe disease based on New York Heart Association functional class III or IV scores (34.2% vs. 54.7% and 53.2%). The types of IE pathogens also differed among the three groups; methicillin-resistant staphylococci was most common in the homograft group (25.6%), whereas the viridans group streptococci was the leading cause of IE in the mechanical (38% ) and xenograft groups (25.2% ).

The use of homografts involves a highly complex operation, typically requiring a complete aortic root replacement, which “may be the major drawback in recommending it to patients already at high risk of operative mortality,” the investigators wrote. The durability of homografts makes their use limited for younger patients, and such grafts are somewhat scarce and require cryopreservation. “Therefore, the notion that homografts are required may in practice present an obstacle to appropriate surgical management of patients who have IE,” Dr. Kim and his coauthors wrote. All patients but one in the homograft group received aortic arch replacement (98.8%) whereas 30 of the patients in the conventional group did so (13.8%).

The study findings are consistent with an earlier comparative study (Ann. Thorac. Surg. 2012;93:480-07), according to Dr. Kim and his colleagues. “These findings suggest that patient-specific factors, such as patient preferences and technical considerations, should be the principal drivers of choices of valve prostheses,” they said. “Furthermore, lack of access to homografts should not be considered an obstacle to surgical therapy for this serious condition.”

Coauthor Dr. Sundt disclosed that he is a consultant for Thrasos Therapeutics. Dr. Kim and the other coauthors had no financial disclosures. 

References

Body

The study by Dr. Kim and his colleagues joins a series of reports questioning conventional thinking on the use of homografts to prevent recurrent infective endocarditis (IE), but their propensity matching does not account for surgeon bias in selecting a prosthesis, Dr. James K. Kirklin of the University of Alabama at Birmingham said in his invited commentary (J Thorac. Cardiovasc Surg. 2016 May;151:1230-1).

For example, surgeon preference may account for the wide disparity in full root replacements, depending on the type of prosthesis, Dr. Kirklin said. “Some experienced homograft surgeons have preferred the intra-aortic cylinder technique or infracoronary implantation, which avoids the short-term and longer-term complexities of full root replacement and has demonstrated long-term structural durability equivalent to that of the full root replacement,” he said.

Also, experienced homograft surgeons may prefer the homograft for its resistance to infection and adaptability to severe root infection in individual patients, particularly in those with severe infection with an abscess. And he cautioned against the study’s implication that conventional prostheses are equivocal in the setting of IE.

“Of considerable importance, however, is the evidence-based conclusion that surgical referral of routine surgical aortic valve endocarditis to a center experienced with aortic homograft surgery is not necessary, and a justifiable expectation is that aortic valve endocarditis requiring operation can be safely and appropriately managed in centers with standard aortic valve surgery experience who do not have access to or experience with aortic valve homografts,” Dr. Kirklin concluded.

Dr. Kirklin had no financial relationships to disclose.

Dr. Christopher M. Feindel

The series by Dr. Kim and his colleagues, one of the largest of acute infective endocarditis to date, provides further evidence that the type of prosthesis used in surgery for IE involving the aortic valve probably does not affect long-term outcomes or reinfection rates, Dr. Christopher M. Feindel of the University of Toronto said in his invited commentary (J Thorac Cardiovasc Surg. 2016 May;151:1249-50).

However, Dr. Feindel said, “numerous confounding factors” inherent in any observational study could raise questions about the conclusion.

“This article delivers an important message, although not all surgeons will agree with the statistical approach taken by Dr. Kim and his colleagues,” Dr. Feindel said. The propensity scoring method the study used lacked all baseline variables that affect treatment choice and outcomes, “a crucial assumption for effective use of the propensity score,” he said. However, given the multitude of variables in patients with acute and complex IE, he said most surgeons would be hard pressed to accept that’s even possible in the model the study used.

Dr. Feindel also said a close examination of the 115 patients who underwent root replacement would have been “very instructional,” and the lack of follow-up on valve-related complications in almost 25% of the patients is another limitation of the study.

Nonetheless, the conclusions of Dr. Kim and his colleagues are “reasonable,” Dr. Feindel said. “Clearly, this article contributes important additional information to the surgical management of IE that will help guide surgeons, especially when it comes to prosthesis of choice,” he concluded. “It is up to the reader to decide whether this report finally puts to rest the “dogma” that homografts should preferentially be used in the setting of IE.”

Dr. Feindel had no relationships to disclose.

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The study by Dr. Kim and his colleagues joins a series of reports questioning conventional thinking on the use of homografts to prevent recurrent infective endocarditis (IE), but their propensity matching does not account for surgeon bias in selecting a prosthesis, Dr. James K. Kirklin of the University of Alabama at Birmingham said in his invited commentary (J Thorac. Cardiovasc Surg. 2016 May;151:1230-1).

For example, surgeon preference may account for the wide disparity in full root replacements, depending on the type of prosthesis, Dr. Kirklin said. “Some experienced homograft surgeons have preferred the intra-aortic cylinder technique or infracoronary implantation, which avoids the short-term and longer-term complexities of full root replacement and has demonstrated long-term structural durability equivalent to that of the full root replacement,” he said.

Also, experienced homograft surgeons may prefer the homograft for its resistance to infection and adaptability to severe root infection in individual patients, particularly in those with severe infection with an abscess. And he cautioned against the study’s implication that conventional prostheses are equivocal in the setting of IE.

“Of considerable importance, however, is the evidence-based conclusion that surgical referral of routine surgical aortic valve endocarditis to a center experienced with aortic homograft surgery is not necessary, and a justifiable expectation is that aortic valve endocarditis requiring operation can be safely and appropriately managed in centers with standard aortic valve surgery experience who do not have access to or experience with aortic valve homografts,” Dr. Kirklin concluded.

Dr. Kirklin had no financial relationships to disclose.

Dr. Christopher M. Feindel

The series by Dr. Kim and his colleagues, one of the largest of acute infective endocarditis to date, provides further evidence that the type of prosthesis used in surgery for IE involving the aortic valve probably does not affect long-term outcomes or reinfection rates, Dr. Christopher M. Feindel of the University of Toronto said in his invited commentary (J Thorac Cardiovasc Surg. 2016 May;151:1249-50).

However, Dr. Feindel said, “numerous confounding factors” inherent in any observational study could raise questions about the conclusion.

“This article delivers an important message, although not all surgeons will agree with the statistical approach taken by Dr. Kim and his colleagues,” Dr. Feindel said. The propensity scoring method the study used lacked all baseline variables that affect treatment choice and outcomes, “a crucial assumption for effective use of the propensity score,” he said. However, given the multitude of variables in patients with acute and complex IE, he said most surgeons would be hard pressed to accept that’s even possible in the model the study used.

Dr. Feindel also said a close examination of the 115 patients who underwent root replacement would have been “very instructional,” and the lack of follow-up on valve-related complications in almost 25% of the patients is another limitation of the study.

Nonetheless, the conclusions of Dr. Kim and his colleagues are “reasonable,” Dr. Feindel said. “Clearly, this article contributes important additional information to the surgical management of IE that will help guide surgeons, especially when it comes to prosthesis of choice,” he concluded. “It is up to the reader to decide whether this report finally puts to rest the “dogma” that homografts should preferentially be used in the setting of IE.”

Dr. Feindel had no relationships to disclose.

Body

The study by Dr. Kim and his colleagues joins a series of reports questioning conventional thinking on the use of homografts to prevent recurrent infective endocarditis (IE), but their propensity matching does not account for surgeon bias in selecting a prosthesis, Dr. James K. Kirklin of the University of Alabama at Birmingham said in his invited commentary (J Thorac. Cardiovasc Surg. 2016 May;151:1230-1).

For example, surgeon preference may account for the wide disparity in full root replacements, depending on the type of prosthesis, Dr. Kirklin said. “Some experienced homograft surgeons have preferred the intra-aortic cylinder technique or infracoronary implantation, which avoids the short-term and longer-term complexities of full root replacement and has demonstrated long-term structural durability equivalent to that of the full root replacement,” he said.

Also, experienced homograft surgeons may prefer the homograft for its resistance to infection and adaptability to severe root infection in individual patients, particularly in those with severe infection with an abscess. And he cautioned against the study’s implication that conventional prostheses are equivocal in the setting of IE.

“Of considerable importance, however, is the evidence-based conclusion that surgical referral of routine surgical aortic valve endocarditis to a center experienced with aortic homograft surgery is not necessary, and a justifiable expectation is that aortic valve endocarditis requiring operation can be safely and appropriately managed in centers with standard aortic valve surgery experience who do not have access to or experience with aortic valve homografts,” Dr. Kirklin concluded.

Dr. Kirklin had no financial relationships to disclose.

Dr. Christopher M. Feindel

The series by Dr. Kim and his colleagues, one of the largest of acute infective endocarditis to date, provides further evidence that the type of prosthesis used in surgery for IE involving the aortic valve probably does not affect long-term outcomes or reinfection rates, Dr. Christopher M. Feindel of the University of Toronto said in his invited commentary (J Thorac Cardiovasc Surg. 2016 May;151:1249-50).

However, Dr. Feindel said, “numerous confounding factors” inherent in any observational study could raise questions about the conclusion.

“This article delivers an important message, although not all surgeons will agree with the statistical approach taken by Dr. Kim and his colleagues,” Dr. Feindel said. The propensity scoring method the study used lacked all baseline variables that affect treatment choice and outcomes, “a crucial assumption for effective use of the propensity score,” he said. However, given the multitude of variables in patients with acute and complex IE, he said most surgeons would be hard pressed to accept that’s even possible in the model the study used.

Dr. Feindel also said a close examination of the 115 patients who underwent root replacement would have been “very instructional,” and the lack of follow-up on valve-related complications in almost 25% of the patients is another limitation of the study.

Nonetheless, the conclusions of Dr. Kim and his colleagues are “reasonable,” Dr. Feindel said. “Clearly, this article contributes important additional information to the surgical management of IE that will help guide surgeons, especially when it comes to prosthesis of choice,” he concluded. “It is up to the reader to decide whether this report finally puts to rest the “dogma” that homografts should preferentially be used in the setting of IE.”

Dr. Feindel had no relationships to disclose.

Title
Two commentaries: ‘Reasonable’ conclusions, but questions remain
Two commentaries: ‘Reasonable’ conclusions, but questions remain

When a patient undergoes aortic valve replacement for infective endocarditis, conventional thinking holds that cardiac surgeons should use homografts because they have greater resistance to infection, but a recent study of more than 300 cases at two academic medical centers concluded that homografts may not necessarily offer such a benefit.

The study, published in the June issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:1239-48), involved 304 consecutive adult patients on whom 30-40 different surgeons performed operations for active infective endocarditis (IE) in the aortic valve from 2002 to 2014.

©CDC/Janice Haney Carr
Under a very high magnification of 50,000x, this scanning electron micrograph shows a strain of Staphylococcus aureus bacteria taken from a vancomycin intermediate resistant culture.

“Our findings suggest that patient-specific factors, such as age and implant preference, as well as technical reconstructive considerations, should drive prosthetic choice, rather than surgical dogma,” said Joon Bum Kim, Ph.D., of Massachusetts General Hospital, Harvard Medical School, both in Boston, and Asan Medical Center in Seoul, Korea, and his colleagues.

The study found that cardiac surgeons favored homografts over conventional prostheses when the patient had prosthetic valve endocarditis (58.1% vs. 28.8%) and methicillin-resistant Staphylococcus aureus (25.6% vs. 12.1%), both significant differences.

“No significant benefit to the use of homografts was demonstrable with regard to resistance to reinfection in the setting of IE,” Dr. Kim and his colleagues said.

Because reinfection after valve replacement for IE is such a strong concern, the debate over which prosthesis is best has ensued for decades. The researchers pointed out that the evidence favoring autologous or allogeneic tissue over synthetic material in the infective field is weak, mostly built on single-armed observational studies without comparison to conventional prosthesis.

With that in mind, the researchers pooled data from two institutions to compare short- and long-term results for homograft vs. conventional prosthetic valves in patients with IE. In this study group, 86 (28.3%) had homografts, 139 (45.7%) had xenograft prostheses, and 79 (26%) mechanical prostheses. The homograft group had more than twice the rate of early death than did the conventional group – 19.8% vs. 9.2%, a significant difference (P = .019).

During follow-up, which ranged from 4.7 to 72.6 months, 60 patients (19.7%) of the total group died and 23 (7.7%) experienced reinfection, but rates did not vary between the homograft and conventional prosthesis groups, Dr. Kim and his colleagues reported.

Demographics were similar between the three groups with a few exceptions Those who received the mechanical prostheses were younger (mean age, 47.2 years vs. 55.6 and 59.8 for the homograft and xenograft groups, respectively), had lower rates of diabetes (5.1% vs. 10.5% and 12.2%) and had less-severe disease based on New York Heart Association functional class III or IV scores (34.2% vs. 54.7% and 53.2%). The types of IE pathogens also differed among the three groups; methicillin-resistant staphylococci was most common in the homograft group (25.6%), whereas the viridans group streptococci was the leading cause of IE in the mechanical (38% ) and xenograft groups (25.2% ).

The use of homografts involves a highly complex operation, typically requiring a complete aortic root replacement, which “may be the major drawback in recommending it to patients already at high risk of operative mortality,” the investigators wrote. The durability of homografts makes their use limited for younger patients, and such grafts are somewhat scarce and require cryopreservation. “Therefore, the notion that homografts are required may in practice present an obstacle to appropriate surgical management of patients who have IE,” Dr. Kim and his coauthors wrote. All patients but one in the homograft group received aortic arch replacement (98.8%) whereas 30 of the patients in the conventional group did so (13.8%).

The study findings are consistent with an earlier comparative study (Ann. Thorac. Surg. 2012;93:480-07), according to Dr. Kim and his colleagues. “These findings suggest that patient-specific factors, such as patient preferences and technical considerations, should be the principal drivers of choices of valve prostheses,” they said. “Furthermore, lack of access to homografts should not be considered an obstacle to surgical therapy for this serious condition.”

Coauthor Dr. Sundt disclosed that he is a consultant for Thrasos Therapeutics. Dr. Kim and the other coauthors had no financial disclosures. 

When a patient undergoes aortic valve replacement for infective endocarditis, conventional thinking holds that cardiac surgeons should use homografts because they have greater resistance to infection, but a recent study of more than 300 cases at two academic medical centers concluded that homografts may not necessarily offer such a benefit.

The study, published in the June issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:1239-48), involved 304 consecutive adult patients on whom 30-40 different surgeons performed operations for active infective endocarditis (IE) in the aortic valve from 2002 to 2014.

©CDC/Janice Haney Carr
Under a very high magnification of 50,000x, this scanning electron micrograph shows a strain of Staphylococcus aureus bacteria taken from a vancomycin intermediate resistant culture.

“Our findings suggest that patient-specific factors, such as age and implant preference, as well as technical reconstructive considerations, should drive prosthetic choice, rather than surgical dogma,” said Joon Bum Kim, Ph.D., of Massachusetts General Hospital, Harvard Medical School, both in Boston, and Asan Medical Center in Seoul, Korea, and his colleagues.

The study found that cardiac surgeons favored homografts over conventional prostheses when the patient had prosthetic valve endocarditis (58.1% vs. 28.8%) and methicillin-resistant Staphylococcus aureus (25.6% vs. 12.1%), both significant differences.

“No significant benefit to the use of homografts was demonstrable with regard to resistance to reinfection in the setting of IE,” Dr. Kim and his colleagues said.

Because reinfection after valve replacement for IE is such a strong concern, the debate over which prosthesis is best has ensued for decades. The researchers pointed out that the evidence favoring autologous or allogeneic tissue over synthetic material in the infective field is weak, mostly built on single-armed observational studies without comparison to conventional prosthesis.

With that in mind, the researchers pooled data from two institutions to compare short- and long-term results for homograft vs. conventional prosthetic valves in patients with IE. In this study group, 86 (28.3%) had homografts, 139 (45.7%) had xenograft prostheses, and 79 (26%) mechanical prostheses. The homograft group had more than twice the rate of early death than did the conventional group – 19.8% vs. 9.2%, a significant difference (P = .019).

During follow-up, which ranged from 4.7 to 72.6 months, 60 patients (19.7%) of the total group died and 23 (7.7%) experienced reinfection, but rates did not vary between the homograft and conventional prosthesis groups, Dr. Kim and his colleagues reported.

Demographics were similar between the three groups with a few exceptions Those who received the mechanical prostheses were younger (mean age, 47.2 years vs. 55.6 and 59.8 for the homograft and xenograft groups, respectively), had lower rates of diabetes (5.1% vs. 10.5% and 12.2%) and had less-severe disease based on New York Heart Association functional class III or IV scores (34.2% vs. 54.7% and 53.2%). The types of IE pathogens also differed among the three groups; methicillin-resistant staphylococci was most common in the homograft group (25.6%), whereas the viridans group streptococci was the leading cause of IE in the mechanical (38% ) and xenograft groups (25.2% ).

The use of homografts involves a highly complex operation, typically requiring a complete aortic root replacement, which “may be the major drawback in recommending it to patients already at high risk of operative mortality,” the investigators wrote. The durability of homografts makes their use limited for younger patients, and such grafts are somewhat scarce and require cryopreservation. “Therefore, the notion that homografts are required may in practice present an obstacle to appropriate surgical management of patients who have IE,” Dr. Kim and his coauthors wrote. All patients but one in the homograft group received aortic arch replacement (98.8%) whereas 30 of the patients in the conventional group did so (13.8%).

The study findings are consistent with an earlier comparative study (Ann. Thorac. Surg. 2012;93:480-07), according to Dr. Kim and his colleagues. “These findings suggest that patient-specific factors, such as patient preferences and technical considerations, should be the principal drivers of choices of valve prostheses,” they said. “Furthermore, lack of access to homografts should not be considered an obstacle to surgical therapy for this serious condition.”

Coauthor Dr. Sundt disclosed that he is a consultant for Thrasos Therapeutics. Dr. Kim and the other coauthors had no financial disclosures. 

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References

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Challenging ‘dogma’ of allografts in infectious endocarditis
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FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY

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Inside the Article

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Key clinical point: Use of homografts showed no significant benefit, compared with conventional prosthetic valves when the patient has infective endocarditis involving the aortic valve.

Major finding: The homograft group had more than twice the rate of early death than the conventional group, 19.8% vs. 9.2%, but in longer-term follow-up, the survival rates did not differ between groups.

Data source: 304 consecutive adult patients from the perspective database of two tertiary academic centers who had surgery for active infective endocarditis involving the aortic valve from 2002 to 2014.

Disclosures: Coauthor Dr. Sundt, disclosed he is a consultant for Thrasos Therapeutics. Dr. Kim and the other coauthors had no financial disclosures.