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The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Zika RNA persists in blood components after clearance from plasma
SAN DIEGO – Zika virus can persist in blood components for several months, long after it is no longer detectable in plasma and other body fluids, based on data reported at the annual meeting of the American Association of Blood Banks.
The presence of Zika virus in plasma declined rapidly following donation, but could be detected in red blood cells (RBCs) and whole blood for up to 3 months. In addition, the virus was also detected intermittently in peripheral blood mononuclear cells (PBMCs) at low levels after clearance from plasma.
“There was longer persistence of Zika RNA in whole blood and RBC blood components than in plasma and other body fluids. It was detected at high levels and persists for about 6 weeks,” Mars Stone, PhD said in presenting the findings.
The findings were based on 2016 data collected in Puerto Rico, which began screening blood donations for Zika virus RNA under an investigational protocol by using a nucleic acid test; they began doing so as a result of guidance from the U.S. Food and Drug Administration. Approximately 350 confirmed infected – that is, nucleic acid test positive (NAT+) – donations were detected through December 2016.
The FDA approved the cobas Zika test used in the study on October 5. Intended for use by blood collection establishments to detect Zika virus in blood donations, the test is manufactured by Roche Molecular Systems. Dr. Stone is an employee of Blood Systems Research Institute, a confirmatory laboratory for Roche.
Of the 52,942 donations collected between April 3 and Dec. 31, 352 were reactive for ZIKV RNA. Plasma from blood donors was screened by individual donation NAT for the presence of ZIKV RNA with the cobas Zika test. At an interval of between 57 and 120 days, no Zika RNA was found in 350 samples of plasma, but it was found in 38.2% (34 samples) of RBCs and 40.0% (35 samples) of whole blood.
In urine and saliva, the virus was detected in high levels at 1-2 weeks, but then rapidly waned. In semen, it was detected at high levels and persisted for about 6 weeks.
“But despite the huge epidemics in Latin America, Puerto Rico, and the other Caribbean islands, there have been no cases of transfusion-related infections linked to RBC transfusions when plasma NAT screening was negative,” said Dr. Stone. “So we are tentatively confirming that red cell–associated virus is not infectious and that plasma NAT screening is likely sufficient.”
The authors point out that RNA persistence has been reported in whole blood long after the virus cleared from plasma and therefore have raised concerns about the risk of transfusion-related viral transmission. The goal of the current study was to characterize the dynamics of infection using donors who were infected with Zika virus.
To date there are 56 donors enrolled in the study, primarily male and from Puerto Rico. Most of them are also positive for dengue fever, Dr. Stone pointed out. “The epidemic in Puerto Rico reached peak in June 2016 but has very little activity this year.”
Plasma and RBCs were collected from index donations, while blood, urine, saliva, and semen samples were collected prospectively at weeks 1, 3, 6, 12, and 24 following index donations. Blood compartments and body fluids were tested for Zika RNA by real time reverse transcription polymerase chain reaction testing, and plasma samples were tested for Zika-specific immunoglobulin M and immunoglobulin G antibodies.
In plasma, Zika virus RNA rapidly decreased after index donations but persisted for up to 3 months in RBCs and whole blood. In peripheral blood mononuclear cells, Zika virus was detected intermittently at low levels but waned by 3 months. In peripheral blood mononuclear cells, Zika RNA was detected in 5.9% (17 samples) at 121-196 days.
Among donors who entered the study while in the acute preseroconversion stage of infection, 65% developed Zika virus symptoms at 1 week post index donation, compared with 30% of donors detected after seroconversion.
The study was funded by the U.S. Department of Health & Human Services.
SAN DIEGO – Zika virus can persist in blood components for several months, long after it is no longer detectable in plasma and other body fluids, based on data reported at the annual meeting of the American Association of Blood Banks.
The presence of Zika virus in plasma declined rapidly following donation, but could be detected in red blood cells (RBCs) and whole blood for up to 3 months. In addition, the virus was also detected intermittently in peripheral blood mononuclear cells (PBMCs) at low levels after clearance from plasma.
“There was longer persistence of Zika RNA in whole blood and RBC blood components than in plasma and other body fluids. It was detected at high levels and persists for about 6 weeks,” Mars Stone, PhD said in presenting the findings.
The findings were based on 2016 data collected in Puerto Rico, which began screening blood donations for Zika virus RNA under an investigational protocol by using a nucleic acid test; they began doing so as a result of guidance from the U.S. Food and Drug Administration. Approximately 350 confirmed infected – that is, nucleic acid test positive (NAT+) – donations were detected through December 2016.
The FDA approved the cobas Zika test used in the study on October 5. Intended for use by blood collection establishments to detect Zika virus in blood donations, the test is manufactured by Roche Molecular Systems. Dr. Stone is an employee of Blood Systems Research Institute, a confirmatory laboratory for Roche.
Of the 52,942 donations collected between April 3 and Dec. 31, 352 were reactive for ZIKV RNA. Plasma from blood donors was screened by individual donation NAT for the presence of ZIKV RNA with the cobas Zika test. At an interval of between 57 and 120 days, no Zika RNA was found in 350 samples of plasma, but it was found in 38.2% (34 samples) of RBCs and 40.0% (35 samples) of whole blood.
In urine and saliva, the virus was detected in high levels at 1-2 weeks, but then rapidly waned. In semen, it was detected at high levels and persisted for about 6 weeks.
“But despite the huge epidemics in Latin America, Puerto Rico, and the other Caribbean islands, there have been no cases of transfusion-related infections linked to RBC transfusions when plasma NAT screening was negative,” said Dr. Stone. “So we are tentatively confirming that red cell–associated virus is not infectious and that plasma NAT screening is likely sufficient.”
The authors point out that RNA persistence has been reported in whole blood long after the virus cleared from plasma and therefore have raised concerns about the risk of transfusion-related viral transmission. The goal of the current study was to characterize the dynamics of infection using donors who were infected with Zika virus.
To date there are 56 donors enrolled in the study, primarily male and from Puerto Rico. Most of them are also positive for dengue fever, Dr. Stone pointed out. “The epidemic in Puerto Rico reached peak in June 2016 but has very little activity this year.”
Plasma and RBCs were collected from index donations, while blood, urine, saliva, and semen samples were collected prospectively at weeks 1, 3, 6, 12, and 24 following index donations. Blood compartments and body fluids were tested for Zika RNA by real time reverse transcription polymerase chain reaction testing, and plasma samples were tested for Zika-specific immunoglobulin M and immunoglobulin G antibodies.
In plasma, Zika virus RNA rapidly decreased after index donations but persisted for up to 3 months in RBCs and whole blood. In peripheral blood mononuclear cells, Zika virus was detected intermittently at low levels but waned by 3 months. In peripheral blood mononuclear cells, Zika RNA was detected in 5.9% (17 samples) at 121-196 days.
Among donors who entered the study while in the acute preseroconversion stage of infection, 65% developed Zika virus symptoms at 1 week post index donation, compared with 30% of donors detected after seroconversion.
The study was funded by the U.S. Department of Health & Human Services.
SAN DIEGO – Zika virus can persist in blood components for several months, long after it is no longer detectable in plasma and other body fluids, based on data reported at the annual meeting of the American Association of Blood Banks.
The presence of Zika virus in plasma declined rapidly following donation, but could be detected in red blood cells (RBCs) and whole blood for up to 3 months. In addition, the virus was also detected intermittently in peripheral blood mononuclear cells (PBMCs) at low levels after clearance from plasma.
“There was longer persistence of Zika RNA in whole blood and RBC blood components than in plasma and other body fluids. It was detected at high levels and persists for about 6 weeks,” Mars Stone, PhD said in presenting the findings.
The findings were based on 2016 data collected in Puerto Rico, which began screening blood donations for Zika virus RNA under an investigational protocol by using a nucleic acid test; they began doing so as a result of guidance from the U.S. Food and Drug Administration. Approximately 350 confirmed infected – that is, nucleic acid test positive (NAT+) – donations were detected through December 2016.
The FDA approved the cobas Zika test used in the study on October 5. Intended for use by blood collection establishments to detect Zika virus in blood donations, the test is manufactured by Roche Molecular Systems. Dr. Stone is an employee of Blood Systems Research Institute, a confirmatory laboratory for Roche.
Of the 52,942 donations collected between April 3 and Dec. 31, 352 were reactive for ZIKV RNA. Plasma from blood donors was screened by individual donation NAT for the presence of ZIKV RNA with the cobas Zika test. At an interval of between 57 and 120 days, no Zika RNA was found in 350 samples of plasma, but it was found in 38.2% (34 samples) of RBCs and 40.0% (35 samples) of whole blood.
In urine and saliva, the virus was detected in high levels at 1-2 weeks, but then rapidly waned. In semen, it was detected at high levels and persisted for about 6 weeks.
“But despite the huge epidemics in Latin America, Puerto Rico, and the other Caribbean islands, there have been no cases of transfusion-related infections linked to RBC transfusions when plasma NAT screening was negative,” said Dr. Stone. “So we are tentatively confirming that red cell–associated virus is not infectious and that plasma NAT screening is likely sufficient.”
The authors point out that RNA persistence has been reported in whole blood long after the virus cleared from plasma and therefore have raised concerns about the risk of transfusion-related viral transmission. The goal of the current study was to characterize the dynamics of infection using donors who were infected with Zika virus.
To date there are 56 donors enrolled in the study, primarily male and from Puerto Rico. Most of them are also positive for dengue fever, Dr. Stone pointed out. “The epidemic in Puerto Rico reached peak in June 2016 but has very little activity this year.”
Plasma and RBCs were collected from index donations, while blood, urine, saliva, and semen samples were collected prospectively at weeks 1, 3, 6, 12, and 24 following index donations. Blood compartments and body fluids were tested for Zika RNA by real time reverse transcription polymerase chain reaction testing, and plasma samples were tested for Zika-specific immunoglobulin M and immunoglobulin G antibodies.
In plasma, Zika virus RNA rapidly decreased after index donations but persisted for up to 3 months in RBCs and whole blood. In peripheral blood mononuclear cells, Zika virus was detected intermittently at low levels but waned by 3 months. In peripheral blood mononuclear cells, Zika RNA was detected in 5.9% (17 samples) at 121-196 days.
Among donors who entered the study while in the acute preseroconversion stage of infection, 65% developed Zika virus symptoms at 1 week post index donation, compared with 30% of donors detected after seroconversion.
The study was funded by the U.S. Department of Health & Human Services.
AT AABB17
Key clinical point: Zika virus can persist in cellular blood components for months after clearance from plasma.
Major finding: Plasma viremia rapidly declined after index donations, but
Data source: Zika RNA persistence in blood components after clearance of viremia in plasma was evaluated in 56 donors positive for Zika virus.
Disclosures: Dr. Stone is an employee of Blood Systems Research Institute in San Francisco, a confirmatory laboratory for Roche Molecular Systems, which manufactures the testing device used. The study was funded by the U.S. Department of Health & Human Services.
Source: Stone M et al. AABB 2017 Abstract C9-A01AC.
Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy
Clinical question: Is alcohol septal ablation (ASA) safe in younger patients with obstructive hypertrophic cardiomyopathy (HCM)?
Background: ASA is a class III recommendation for younger patients when myectomy is a viable option. This recommendation was based on the lack of evidence for younger patients whereas myectomy already was proven to be safe and effective.
Setting: 7 tertiary centers from 4 European countries during 1996-2015.
Synopsis: With 1,200 patients, this was the largest ASA cohort to date. The cohort was divided into three groups: young (less than 50 years), middle age (51-65 years), and old (greater than 65 years). During the periprocedural period, young patients had better outcomes than did older patients in regards to complete heart block, cardiac tamponade, and mortality. After 5.4 years of follow-up, young patients had favorable outcomes for long-term survival after ASA and comparable rates of adverse antiarrhythmic events; 95% of these young patients were functioning in NYHA class I or II at follow-up. These young patients also had half the risk of permanent pacemaker implantation, compared with older patients. In an analysis of very young patients (younger than 35 years), ASA appeared to be safe and effective as well. Additionally, young patients who were treated with more than 2.5 mL alcohol had higher all-cause mortality, compared with patients who were treated with less than 2.5 mL.
Bottom line: For patients aged 50 years or less with HCM, ASA and surgical myectomy are both safe and effective for relief of symptoms.
Citation: Liebregts M et al. Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy. JACC: Cardiovascular Interventions. Jun 2017:1134-43.
Dr. Setji is a hospitalist and medical director, Duke University Hospital.
Clinical question: Is alcohol septal ablation (ASA) safe in younger patients with obstructive hypertrophic cardiomyopathy (HCM)?
Background: ASA is a class III recommendation for younger patients when myectomy is a viable option. This recommendation was based on the lack of evidence for younger patients whereas myectomy already was proven to be safe and effective.
Setting: 7 tertiary centers from 4 European countries during 1996-2015.
Synopsis: With 1,200 patients, this was the largest ASA cohort to date. The cohort was divided into three groups: young (less than 50 years), middle age (51-65 years), and old (greater than 65 years). During the periprocedural period, young patients had better outcomes than did older patients in regards to complete heart block, cardiac tamponade, and mortality. After 5.4 years of follow-up, young patients had favorable outcomes for long-term survival after ASA and comparable rates of adverse antiarrhythmic events; 95% of these young patients were functioning in NYHA class I or II at follow-up. These young patients also had half the risk of permanent pacemaker implantation, compared with older patients. In an analysis of very young patients (younger than 35 years), ASA appeared to be safe and effective as well. Additionally, young patients who were treated with more than 2.5 mL alcohol had higher all-cause mortality, compared with patients who were treated with less than 2.5 mL.
Bottom line: For patients aged 50 years or less with HCM, ASA and surgical myectomy are both safe and effective for relief of symptoms.
Citation: Liebregts M et al. Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy. JACC: Cardiovascular Interventions. Jun 2017:1134-43.
Dr. Setji is a hospitalist and medical director, Duke University Hospital.
Clinical question: Is alcohol septal ablation (ASA) safe in younger patients with obstructive hypertrophic cardiomyopathy (HCM)?
Background: ASA is a class III recommendation for younger patients when myectomy is a viable option. This recommendation was based on the lack of evidence for younger patients whereas myectomy already was proven to be safe and effective.
Setting: 7 tertiary centers from 4 European countries during 1996-2015.
Synopsis: With 1,200 patients, this was the largest ASA cohort to date. The cohort was divided into three groups: young (less than 50 years), middle age (51-65 years), and old (greater than 65 years). During the periprocedural period, young patients had better outcomes than did older patients in regards to complete heart block, cardiac tamponade, and mortality. After 5.4 years of follow-up, young patients had favorable outcomes for long-term survival after ASA and comparable rates of adverse antiarrhythmic events; 95% of these young patients were functioning in NYHA class I or II at follow-up. These young patients also had half the risk of permanent pacemaker implantation, compared with older patients. In an analysis of very young patients (younger than 35 years), ASA appeared to be safe and effective as well. Additionally, young patients who were treated with more than 2.5 mL alcohol had higher all-cause mortality, compared with patients who were treated with less than 2.5 mL.
Bottom line: For patients aged 50 years or less with HCM, ASA and surgical myectomy are both safe and effective for relief of symptoms.
Citation: Liebregts M et al. Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy. JACC: Cardiovascular Interventions. Jun 2017:1134-43.
Dr. Setji is a hospitalist and medical director, Duke University Hospital.
How will SNF readmissions penalties affect hospitalists?
Starting in 2018, skilled nursing facilities (SNFs), like acute care hospitals before them, will be subject to a penalty of up to 2% of their Medicare reimbursement for posting higher-than-average rates of hospital readmissions.
The Protecting Access to Medicare Act of 2014 established a value-based purchasing component for SNFs, including incentives for high-performing facilities and a measure for all-cause, all-condition readmissions to any hospital from the SNF within 30 days following hospital discharge – designed to recognize and reward, or punish, facilities’ performance on preventing unnecessary readmissions. Public reporting of SNF quality data, including readmission rates, started in October 2017. Penalties follow a year later. Some patients’ readmissions could trigger penalties for both the hospital and the SNF.
According to 2010 data, 23.5% of patients discharged from acute care hospitals to SNFs were readmitted to the hospital within 30 days, at a financial cost of $10,362 per readmission or $4.34 billion per year.1 Seventy eight percent of these readmissions were labeled avoidable. More recent evidence suggests that hospitalization rates for dual-eligible patients living in long-term care facilities decreased by 31% between 2010 and 2015.2As increasing numbers of hospitalists spend some or all of their work week in post-acute care settings, how will the SNF readmission penalty affect their relationships with post-acute facilities?
Experts say SNFs – as with hospitals before them – lack the ability to allocate rewards or penalties for readmission rate performance to individual doctors. But increasingly close collaborative relationships between post-acute facilities and the hospitalists who work in post-acute care mean that the hospitalist has an important role in helping the SNF to manage its readmissions exposure.
“Hospitals and hospitalists want to keep good relationships with the SNFs they partner with, for a variety of reasons,” Dr. Frizner said. “We believe that the best way to reduce readmissions and unplanned transfers from the SNF is for the doctor to know the patient. We need dedicated doctors in the facility. We want hospitalists who already know the patient to come to the facility and see the patient there.”
The hospitalist’s role in post-acute care
Hospitalists who work in post-acute care typically make scheduled, billable medical visits to patients in long-term care facilities, and may also take on roles such as facility medical director or contribute to quality improvement. Relationships may be initiated by a facility seeking more medical coverage, by a hospitalist group seeking additional work or an ability to impact on the post-acute care delivered to hospital patients discharged to the facility, or by health systems, health plans, or accountable care organizations seeking to better manage the quality of care transitions for their beneficiaries.
“What I’m seeing is that with opportunities for bundled payments, we all have new incentives for moving patients along and reducing waste,” Dr. Boutwell said. “For hospitalists practicing in SNFs, it’s going to be a much bigger phenomenon. They’ll be called to reevaluate patients and make more visits than they have been accustomed to.” She hopes SNFs are studying what happened with hospitals’ readmission penalties, and will respond more quickly and effectively to their own penalty exposure.
“What we are seeing is an effort to shift folks to lower cost – but still clinically appropriate – levels of care,” he said. “These dynamics will force SNFs to reevaluate and improve their clinical competencies, to accept patients and then treat them in place. It’s no longer acceptable for the medical director to make rounds in person twice a month and do the rest by telephone.”
Instead, someone needs to be on site several times a week, working with nursing staff and developing protocols and pathways to control variability, Dr. Harrington said. “And in many cases that will be a hospitalist. Hospitalists are finding ways to partner and provide that level of care. I believe good hospitalist groups can change the facility for the better, and fairly quickly.”
What happens in post-acute care
Cari Levy, MD, PhD, who does hospital coverage and post-acute care for a number of facilities and home health agencies in the Denver area, calls the changes coming to SNFs a thrilling time for post-acute care.
“Suddenly medical professionals care about what happens in the post-acute world,” she said. “Everyone is now looking at the same measures. If this works the way it should, there would be a lot more mutual respect between providers.”
SNFs that are concerned about their readmissions rates will want to do root cause analysis to figure out what’s going on, Dr. Levy said. “Maybe the doctor didn’t do a good assessment. Maybe it was just a tough case. Once you start talking, you’ll develop systems to help everyone responsible. Hospitalists can be part of that conversation,” she said.
“You can have a good outcome at Shady Oaks and a terrible outcome at Whispering Pines, for all sorts of reasons. The hospital wants to make sure we’re sending patients to facilities that produce good outcomes,” he explained. “But there has to be communication between providers – the SNF medical director, the hospitalists, and the emergency department.”
A TeamHealth doctor in Phoenix has convened a consortium of providers from different care settings to meet and talk about cases and how they could have gone better. “The reality is, these conversations are going on all over,” Dr. Wilborn said. “What’s driving them is the realization of what we all need to do in this new environment.”
Opportunities from reforms
Robert Burke, MD, FHM, assistant chief of Hospital Medicine at the Denver VA Medical Center, is lead author of a study in the Journal of Hospital Medicine highlighting implications and opportunities from reforms in post-acute care.3 Hospitalists may not appreciate that post-acute care is poised to undergo transformative change from the recently legislated reforms, opening opportunities for hospitalists to improve health care value by improving transitions of care, he noted.
“My sense is that payment reform will put pressure on physicians to use home health care more often than institutional care, because of the cost pressures. We know that hospitalists choose long-term care facility placements less often when participating in bundled payment,” Dr. Burke said. “I think few hospitalists really know what happens on a day-to-day basis in SNFs – or in patients’ homes, for that matter.”
According to Dr. Burke, there’s just not enough data currently to guide these decisions. He said that, based on his research, the best thing hospitalists can do is try to understand what’s available in post-acute spaces, and build relationships with post-acute facilities.
“Find ways to get feedback on your discharge decisions,” he said. “Here in Colorado, we met recently with the local chapter of the Society for Post-Acute and Long-Term Care Medicine, also known as AMDA. It’s been revealing for everyone involved.”
He recommends AMDA’s learning modules – which are designed for doctors who are new to long-term care – to any hospitalist who is entering the post-acute world.
References
1. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010 Jan-Feb;29(1):57-64.
2. Brennan N et al. Data Brief: Sharp reduction in avoidable hospitalizations among long-term care facility residents. The CMS Blog, 2017 Jan 17.
3. Burke RE et al. Post-acute care reform: Implications and opportunities for hospitalists. J Hosp Med. 2017 Jan;12(1);46-51.
Starting in 2018, skilled nursing facilities (SNFs), like acute care hospitals before them, will be subject to a penalty of up to 2% of their Medicare reimbursement for posting higher-than-average rates of hospital readmissions.
The Protecting Access to Medicare Act of 2014 established a value-based purchasing component for SNFs, including incentives for high-performing facilities and a measure for all-cause, all-condition readmissions to any hospital from the SNF within 30 days following hospital discharge – designed to recognize and reward, or punish, facilities’ performance on preventing unnecessary readmissions. Public reporting of SNF quality data, including readmission rates, started in October 2017. Penalties follow a year later. Some patients’ readmissions could trigger penalties for both the hospital and the SNF.
According to 2010 data, 23.5% of patients discharged from acute care hospitals to SNFs were readmitted to the hospital within 30 days, at a financial cost of $10,362 per readmission or $4.34 billion per year.1 Seventy eight percent of these readmissions were labeled avoidable. More recent evidence suggests that hospitalization rates for dual-eligible patients living in long-term care facilities decreased by 31% between 2010 and 2015.2As increasing numbers of hospitalists spend some or all of their work week in post-acute care settings, how will the SNF readmission penalty affect their relationships with post-acute facilities?
Experts say SNFs – as with hospitals before them – lack the ability to allocate rewards or penalties for readmission rate performance to individual doctors. But increasingly close collaborative relationships between post-acute facilities and the hospitalists who work in post-acute care mean that the hospitalist has an important role in helping the SNF to manage its readmissions exposure.
“Hospitals and hospitalists want to keep good relationships with the SNFs they partner with, for a variety of reasons,” Dr. Frizner said. “We believe that the best way to reduce readmissions and unplanned transfers from the SNF is for the doctor to know the patient. We need dedicated doctors in the facility. We want hospitalists who already know the patient to come to the facility and see the patient there.”
The hospitalist’s role in post-acute care
Hospitalists who work in post-acute care typically make scheduled, billable medical visits to patients in long-term care facilities, and may also take on roles such as facility medical director or contribute to quality improvement. Relationships may be initiated by a facility seeking more medical coverage, by a hospitalist group seeking additional work or an ability to impact on the post-acute care delivered to hospital patients discharged to the facility, or by health systems, health plans, or accountable care organizations seeking to better manage the quality of care transitions for their beneficiaries.
“What I’m seeing is that with opportunities for bundled payments, we all have new incentives for moving patients along and reducing waste,” Dr. Boutwell said. “For hospitalists practicing in SNFs, it’s going to be a much bigger phenomenon. They’ll be called to reevaluate patients and make more visits than they have been accustomed to.” She hopes SNFs are studying what happened with hospitals’ readmission penalties, and will respond more quickly and effectively to their own penalty exposure.
“What we are seeing is an effort to shift folks to lower cost – but still clinically appropriate – levels of care,” he said. “These dynamics will force SNFs to reevaluate and improve their clinical competencies, to accept patients and then treat them in place. It’s no longer acceptable for the medical director to make rounds in person twice a month and do the rest by telephone.”
Instead, someone needs to be on site several times a week, working with nursing staff and developing protocols and pathways to control variability, Dr. Harrington said. “And in many cases that will be a hospitalist. Hospitalists are finding ways to partner and provide that level of care. I believe good hospitalist groups can change the facility for the better, and fairly quickly.”
What happens in post-acute care
Cari Levy, MD, PhD, who does hospital coverage and post-acute care for a number of facilities and home health agencies in the Denver area, calls the changes coming to SNFs a thrilling time for post-acute care.
“Suddenly medical professionals care about what happens in the post-acute world,” she said. “Everyone is now looking at the same measures. If this works the way it should, there would be a lot more mutual respect between providers.”
SNFs that are concerned about their readmissions rates will want to do root cause analysis to figure out what’s going on, Dr. Levy said. “Maybe the doctor didn’t do a good assessment. Maybe it was just a tough case. Once you start talking, you’ll develop systems to help everyone responsible. Hospitalists can be part of that conversation,” she said.
“You can have a good outcome at Shady Oaks and a terrible outcome at Whispering Pines, for all sorts of reasons. The hospital wants to make sure we’re sending patients to facilities that produce good outcomes,” he explained. “But there has to be communication between providers – the SNF medical director, the hospitalists, and the emergency department.”
A TeamHealth doctor in Phoenix has convened a consortium of providers from different care settings to meet and talk about cases and how they could have gone better. “The reality is, these conversations are going on all over,” Dr. Wilborn said. “What’s driving them is the realization of what we all need to do in this new environment.”
Opportunities from reforms
Robert Burke, MD, FHM, assistant chief of Hospital Medicine at the Denver VA Medical Center, is lead author of a study in the Journal of Hospital Medicine highlighting implications and opportunities from reforms in post-acute care.3 Hospitalists may not appreciate that post-acute care is poised to undergo transformative change from the recently legislated reforms, opening opportunities for hospitalists to improve health care value by improving transitions of care, he noted.
“My sense is that payment reform will put pressure on physicians to use home health care more often than institutional care, because of the cost pressures. We know that hospitalists choose long-term care facility placements less often when participating in bundled payment,” Dr. Burke said. “I think few hospitalists really know what happens on a day-to-day basis in SNFs – or in patients’ homes, for that matter.”
According to Dr. Burke, there’s just not enough data currently to guide these decisions. He said that, based on his research, the best thing hospitalists can do is try to understand what’s available in post-acute spaces, and build relationships with post-acute facilities.
“Find ways to get feedback on your discharge decisions,” he said. “Here in Colorado, we met recently with the local chapter of the Society for Post-Acute and Long-Term Care Medicine, also known as AMDA. It’s been revealing for everyone involved.”
He recommends AMDA’s learning modules – which are designed for doctors who are new to long-term care – to any hospitalist who is entering the post-acute world.
References
1. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010 Jan-Feb;29(1):57-64.
2. Brennan N et al. Data Brief: Sharp reduction in avoidable hospitalizations among long-term care facility residents. The CMS Blog, 2017 Jan 17.
3. Burke RE et al. Post-acute care reform: Implications and opportunities for hospitalists. J Hosp Med. 2017 Jan;12(1);46-51.
Starting in 2018, skilled nursing facilities (SNFs), like acute care hospitals before them, will be subject to a penalty of up to 2% of their Medicare reimbursement for posting higher-than-average rates of hospital readmissions.
The Protecting Access to Medicare Act of 2014 established a value-based purchasing component for SNFs, including incentives for high-performing facilities and a measure for all-cause, all-condition readmissions to any hospital from the SNF within 30 days following hospital discharge – designed to recognize and reward, or punish, facilities’ performance on preventing unnecessary readmissions. Public reporting of SNF quality data, including readmission rates, started in October 2017. Penalties follow a year later. Some patients’ readmissions could trigger penalties for both the hospital and the SNF.
According to 2010 data, 23.5% of patients discharged from acute care hospitals to SNFs were readmitted to the hospital within 30 days, at a financial cost of $10,362 per readmission or $4.34 billion per year.1 Seventy eight percent of these readmissions were labeled avoidable. More recent evidence suggests that hospitalization rates for dual-eligible patients living in long-term care facilities decreased by 31% between 2010 and 2015.2As increasing numbers of hospitalists spend some or all of their work week in post-acute care settings, how will the SNF readmission penalty affect their relationships with post-acute facilities?
Experts say SNFs – as with hospitals before them – lack the ability to allocate rewards or penalties for readmission rate performance to individual doctors. But increasingly close collaborative relationships between post-acute facilities and the hospitalists who work in post-acute care mean that the hospitalist has an important role in helping the SNF to manage its readmissions exposure.
“Hospitals and hospitalists want to keep good relationships with the SNFs they partner with, for a variety of reasons,” Dr. Frizner said. “We believe that the best way to reduce readmissions and unplanned transfers from the SNF is for the doctor to know the patient. We need dedicated doctors in the facility. We want hospitalists who already know the patient to come to the facility and see the patient there.”
The hospitalist’s role in post-acute care
Hospitalists who work in post-acute care typically make scheduled, billable medical visits to patients in long-term care facilities, and may also take on roles such as facility medical director or contribute to quality improvement. Relationships may be initiated by a facility seeking more medical coverage, by a hospitalist group seeking additional work or an ability to impact on the post-acute care delivered to hospital patients discharged to the facility, or by health systems, health plans, or accountable care organizations seeking to better manage the quality of care transitions for their beneficiaries.
“What I’m seeing is that with opportunities for bundled payments, we all have new incentives for moving patients along and reducing waste,” Dr. Boutwell said. “For hospitalists practicing in SNFs, it’s going to be a much bigger phenomenon. They’ll be called to reevaluate patients and make more visits than they have been accustomed to.” She hopes SNFs are studying what happened with hospitals’ readmission penalties, and will respond more quickly and effectively to their own penalty exposure.
“What we are seeing is an effort to shift folks to lower cost – but still clinically appropriate – levels of care,” he said. “These dynamics will force SNFs to reevaluate and improve their clinical competencies, to accept patients and then treat them in place. It’s no longer acceptable for the medical director to make rounds in person twice a month and do the rest by telephone.”
Instead, someone needs to be on site several times a week, working with nursing staff and developing protocols and pathways to control variability, Dr. Harrington said. “And in many cases that will be a hospitalist. Hospitalists are finding ways to partner and provide that level of care. I believe good hospitalist groups can change the facility for the better, and fairly quickly.”
What happens in post-acute care
Cari Levy, MD, PhD, who does hospital coverage and post-acute care for a number of facilities and home health agencies in the Denver area, calls the changes coming to SNFs a thrilling time for post-acute care.
“Suddenly medical professionals care about what happens in the post-acute world,” she said. “Everyone is now looking at the same measures. If this works the way it should, there would be a lot more mutual respect between providers.”
SNFs that are concerned about their readmissions rates will want to do root cause analysis to figure out what’s going on, Dr. Levy said. “Maybe the doctor didn’t do a good assessment. Maybe it was just a tough case. Once you start talking, you’ll develop systems to help everyone responsible. Hospitalists can be part of that conversation,” she said.
“You can have a good outcome at Shady Oaks and a terrible outcome at Whispering Pines, for all sorts of reasons. The hospital wants to make sure we’re sending patients to facilities that produce good outcomes,” he explained. “But there has to be communication between providers – the SNF medical director, the hospitalists, and the emergency department.”
A TeamHealth doctor in Phoenix has convened a consortium of providers from different care settings to meet and talk about cases and how they could have gone better. “The reality is, these conversations are going on all over,” Dr. Wilborn said. “What’s driving them is the realization of what we all need to do in this new environment.”
Opportunities from reforms
Robert Burke, MD, FHM, assistant chief of Hospital Medicine at the Denver VA Medical Center, is lead author of a study in the Journal of Hospital Medicine highlighting implications and opportunities from reforms in post-acute care.3 Hospitalists may not appreciate that post-acute care is poised to undergo transformative change from the recently legislated reforms, opening opportunities for hospitalists to improve health care value by improving transitions of care, he noted.
“My sense is that payment reform will put pressure on physicians to use home health care more often than institutional care, because of the cost pressures. We know that hospitalists choose long-term care facility placements less often when participating in bundled payment,” Dr. Burke said. “I think few hospitalists really know what happens on a day-to-day basis in SNFs – or in patients’ homes, for that matter.”
According to Dr. Burke, there’s just not enough data currently to guide these decisions. He said that, based on his research, the best thing hospitalists can do is try to understand what’s available in post-acute spaces, and build relationships with post-acute facilities.
“Find ways to get feedback on your discharge decisions,” he said. “Here in Colorado, we met recently with the local chapter of the Society for Post-Acute and Long-Term Care Medicine, also known as AMDA. It’s been revealing for everyone involved.”
He recommends AMDA’s learning modules – which are designed for doctors who are new to long-term care – to any hospitalist who is entering the post-acute world.
References
1. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010 Jan-Feb;29(1):57-64.
2. Brennan N et al. Data Brief: Sharp reduction in avoidable hospitalizations among long-term care facility residents. The CMS Blog, 2017 Jan 17.
3. Burke RE et al. Post-acute care reform: Implications and opportunities for hospitalists. J Hosp Med. 2017 Jan;12(1);46-51.
Corynebacterium in the gut can trigger Parkinson’s disease
SAN DIEGO – The presence of Corynebacterium in the gut microbiome of people with two G alleles at the rs356219 single nucleotide polymorphism locus of the alpha-synuclein gene was associated with 100% probability of having Parkinson’s disease in a study conducted by the NeuroGenetics Research Consortium.
If the finding is replicated, it means that Corynebacterium is the trigger for Parkinson’s disease (PD) in people with the GG genotype. The GG signature at rs356219 is the strongest genetic risk factor for PD identified to date, but it’s not necessarily strong enough to cause the disease on its own. “It definitely needs a trigger,” and there’s a good chance that Corynebacterium is it, said senior investigator Haydeh Payami, PhD, professor of neurology and genomics at the University of Alabama, Birmingham.
Her team genotyped SNCA rs356219 from blood samples in 197 middle-aged PD patients and 115 age-matched controls. They also extracted DNA from stool samples to see what bacteria were in their gut and then looked for interactions between rs356219 genotype, gut microbiome, and PD risk.
The medical literature has been full of hints for a while now that PD might be set off by something going wrong in the gastrointestinal tract. Colonic inflammation, alpha-synuclein pathology in the gut, and dysbiosis of the gut microbiome in PD are among the many clues. The goal of the work was to find the link between PD and its GI aberrations.
Ninety genera were identified in the stool samples, but “no matter how you looked at the data, whichever method you used, one [genus] kept coming up” for interaction with the rs356219 genotype, “and that was Corynebacterium,” Dr. Payami said.
As in past studies, the rs356219 AA genotype did not increase the odds of PD, and there was no difference in microbiome abundance between PD patients and controls. The GA genotype increased the odds slightly without Corynebacterium, but it increased the odds more than fivefold when Corynebacterium was in the gut (odds ratio, 5.9; P = .04). If people had GG plus Corynebacterium, however, “you nailed it,” Dr. Payami said: The odds of developing PD were infinite (P = .0003).
Corynebacterium was more abundant in GA subjects with PD than GA subjects without PD, but it was by far the most abundant in GG subjects, and every person who had the GG genotype and gut Corynebacterium also had PD.
Corynebacterium are gram-positive, aerobic bacilli commonly found on the skin. Some members of the genus are opportunistic pathogens. It’s not clear how they get incorporated into the gut microbiome, or if they can be wiped out selectively in the gut with antibiotics or probiotics.
Perhaps Corynebacterium in the GI tract induces expression of alpha-synuclein protein, a major component of PD Lewy bodies that’s known to travel from the gut to the brain. Maybe the amount expressed depends on how many Gs people have in rs356219. Perhaps “if you have two Gs, you get so much alpha-synuclein that’s there’s no turning back, and it’s enough to cause PD,” Dr. Payami said.
The study was led by Zachary Wallen, a PhD candidate in Dr. Payami’s lab, and presented by him at the annual meeting of the American Neurological Association. The work was supported by the National Institutes of Health. Dr. Payami and Mr. Wallen had no industry disclosures.
SOURCE: Wallen Z et al. ANA 2017 abstract number S268
SAN DIEGO – The presence of Corynebacterium in the gut microbiome of people with two G alleles at the rs356219 single nucleotide polymorphism locus of the alpha-synuclein gene was associated with 100% probability of having Parkinson’s disease in a study conducted by the NeuroGenetics Research Consortium.
If the finding is replicated, it means that Corynebacterium is the trigger for Parkinson’s disease (PD) in people with the GG genotype. The GG signature at rs356219 is the strongest genetic risk factor for PD identified to date, but it’s not necessarily strong enough to cause the disease on its own. “It definitely needs a trigger,” and there’s a good chance that Corynebacterium is it, said senior investigator Haydeh Payami, PhD, professor of neurology and genomics at the University of Alabama, Birmingham.
Her team genotyped SNCA rs356219 from blood samples in 197 middle-aged PD patients and 115 age-matched controls. They also extracted DNA from stool samples to see what bacteria were in their gut and then looked for interactions between rs356219 genotype, gut microbiome, and PD risk.
The medical literature has been full of hints for a while now that PD might be set off by something going wrong in the gastrointestinal tract. Colonic inflammation, alpha-synuclein pathology in the gut, and dysbiosis of the gut microbiome in PD are among the many clues. The goal of the work was to find the link between PD and its GI aberrations.
Ninety genera were identified in the stool samples, but “no matter how you looked at the data, whichever method you used, one [genus] kept coming up” for interaction with the rs356219 genotype, “and that was Corynebacterium,” Dr. Payami said.
As in past studies, the rs356219 AA genotype did not increase the odds of PD, and there was no difference in microbiome abundance between PD patients and controls. The GA genotype increased the odds slightly without Corynebacterium, but it increased the odds more than fivefold when Corynebacterium was in the gut (odds ratio, 5.9; P = .04). If people had GG plus Corynebacterium, however, “you nailed it,” Dr. Payami said: The odds of developing PD were infinite (P = .0003).
Corynebacterium was more abundant in GA subjects with PD than GA subjects without PD, but it was by far the most abundant in GG subjects, and every person who had the GG genotype and gut Corynebacterium also had PD.
Corynebacterium are gram-positive, aerobic bacilli commonly found on the skin. Some members of the genus are opportunistic pathogens. It’s not clear how they get incorporated into the gut microbiome, or if they can be wiped out selectively in the gut with antibiotics or probiotics.
Perhaps Corynebacterium in the GI tract induces expression of alpha-synuclein protein, a major component of PD Lewy bodies that’s known to travel from the gut to the brain. Maybe the amount expressed depends on how many Gs people have in rs356219. Perhaps “if you have two Gs, you get so much alpha-synuclein that’s there’s no turning back, and it’s enough to cause PD,” Dr. Payami said.
The study was led by Zachary Wallen, a PhD candidate in Dr. Payami’s lab, and presented by him at the annual meeting of the American Neurological Association. The work was supported by the National Institutes of Health. Dr. Payami and Mr. Wallen had no industry disclosures.
SOURCE: Wallen Z et al. ANA 2017 abstract number S268
SAN DIEGO – The presence of Corynebacterium in the gut microbiome of people with two G alleles at the rs356219 single nucleotide polymorphism locus of the alpha-synuclein gene was associated with 100% probability of having Parkinson’s disease in a study conducted by the NeuroGenetics Research Consortium.
If the finding is replicated, it means that Corynebacterium is the trigger for Parkinson’s disease (PD) in people with the GG genotype. The GG signature at rs356219 is the strongest genetic risk factor for PD identified to date, but it’s not necessarily strong enough to cause the disease on its own. “It definitely needs a trigger,” and there’s a good chance that Corynebacterium is it, said senior investigator Haydeh Payami, PhD, professor of neurology and genomics at the University of Alabama, Birmingham.
Her team genotyped SNCA rs356219 from blood samples in 197 middle-aged PD patients and 115 age-matched controls. They also extracted DNA from stool samples to see what bacteria were in their gut and then looked for interactions between rs356219 genotype, gut microbiome, and PD risk.
The medical literature has been full of hints for a while now that PD might be set off by something going wrong in the gastrointestinal tract. Colonic inflammation, alpha-synuclein pathology in the gut, and dysbiosis of the gut microbiome in PD are among the many clues. The goal of the work was to find the link between PD and its GI aberrations.
Ninety genera were identified in the stool samples, but “no matter how you looked at the data, whichever method you used, one [genus] kept coming up” for interaction with the rs356219 genotype, “and that was Corynebacterium,” Dr. Payami said.
As in past studies, the rs356219 AA genotype did not increase the odds of PD, and there was no difference in microbiome abundance between PD patients and controls. The GA genotype increased the odds slightly without Corynebacterium, but it increased the odds more than fivefold when Corynebacterium was in the gut (odds ratio, 5.9; P = .04). If people had GG plus Corynebacterium, however, “you nailed it,” Dr. Payami said: The odds of developing PD were infinite (P = .0003).
Corynebacterium was more abundant in GA subjects with PD than GA subjects without PD, but it was by far the most abundant in GG subjects, and every person who had the GG genotype and gut Corynebacterium also had PD.
Corynebacterium are gram-positive, aerobic bacilli commonly found on the skin. Some members of the genus are opportunistic pathogens. It’s not clear how they get incorporated into the gut microbiome, or if they can be wiped out selectively in the gut with antibiotics or probiotics.
Perhaps Corynebacterium in the GI tract induces expression of alpha-synuclein protein, a major component of PD Lewy bodies that’s known to travel from the gut to the brain. Maybe the amount expressed depends on how many Gs people have in rs356219. Perhaps “if you have two Gs, you get so much alpha-synuclein that’s there’s no turning back, and it’s enough to cause PD,” Dr. Payami said.
The study was led by Zachary Wallen, a PhD candidate in Dr. Payami’s lab, and presented by him at the annual meeting of the American Neurological Association. The work was supported by the National Institutes of Health. Dr. Payami and Mr. Wallen had no industry disclosures.
SOURCE: Wallen Z et al. ANA 2017 abstract number S268
REPORTING FROM ANA 2017
Key clinical point: in genetically susceptible people.
Major finding: Those who have Corynebacterium in their gut microbiome plus two G alleles at the rs356219 locus of the alpha-synuclein gene have infinite odds of developing PD (P = .0003).
Study details: A case-control study involving 197 middle-aged PD patients and 115 age-matched controls.
Disclosures: The work was supported by the National Institutes of Health. The lead and senior investigators had no industry disclosures.
Source: Wallen Z et al. ANA 2017 abstract number S268
FDA: Laparoscopic power morcellators can spread malignant cells when used in women with occult uterine cancers*
Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.
A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.
The findings reaffirm the agency’s 2014 warnings about LPMs:
• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.
• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”
The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.
Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).
Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.
“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”
[email protected]
Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.
A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.
The findings reaffirm the agency’s 2014 warnings about LPMs:
• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.
• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”
The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.
Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).
Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.
“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”
[email protected]
Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.
A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.
The findings reaffirm the agency’s 2014 warnings about LPMs:
• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.
• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”
The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.
Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).
Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.
“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”
[email protected]
AHA: Childhood adversity strongly linked to poorer health outcomes
Research suggests an association between adverse childhood events and poorer cardiometabolic health across the lifespan, a new scientific statement from the American Heart Association declares, although it acknowledges various limitations in understanding the connection.
Studies haven’t confirmed a cause-and-effect relationship or the full extent of excess risk, and it’s not clear why some people who experience childhood trauma are more resilient than others. There’s also scant information about any link to higher cardiometabolic death rates.
For the new statement, which appears in Circulation, researchers reviewed recent systematic reviews into the links between childhood adversity – including events like violence and abuse – and cardiometabolic outcome.
By one estimate, nearly 60% of adults in the United States experienced at least one adverse childhood event. According to the statement, reviews have linked childhood adversity to higher risks of cardiac death and outcomes like heart attack and stroke. They’ve also linked adversity to risk factors like high blood pressure, obesity, and type 2 diabetes.
the statement said. However, Dr. Suglia noted that research into mortality is limited.
The level of higher risk varies by study and outcome, and no one knows if there’s a cause-and-effect link. “As you can imagine, child adversity is not an exposure that lends itself to randomized trials,” she said. “On top of that, we are talking about health effects that take many years to manifest so we rely on observational studies.”
However, “while there is a possibility that there is an alternate factor that is responsible for these associations, the evidence is consistent across different populations,” said Dr. Suglia of Emory University in Atlanta. “And in general, studies do consider alternative factors that may be associated with both child adversity and cardiovascular health, further strengthening inferences we can make from the observational studies.”
Why might the association exist? “The mechanisms that drive these associations are still not fully elucidated but we hypothesize three pathways that may mediate these associations: behavioral factors (diet, sleep, physical activity, smoking), biological (hypothalamic-pituitary-adrenal axis dysregulation, epigenetic, chronic inflammation), and mental health (posttraumatic stress disorder and depression),” she said.
The statement notes that research is limited into why some people thrive on the cardiometabolic front despite childhood adversity. “One of the recommendations is that we need to focus more on factors that could inform prevention and intervention efforts so that those that are affected by adversity in childhood are not also affected by adverse cardiovascular events,” Dr. Suglia said.
The statement also notes that there’s been only limited research into modifiers of vulnerability to the effects of childhood adversity, such as gender, race/ethnicity, genetics, and community characteristics. And it says there’s been little study of how early interventions may affect cardiometabolic outcomes: “Additional research, including longitudinal prospective studies, designed to guide and inform effective and timely individual/clinical and population-level preventive interventions is required.”
Dr. Suglia reports a research grant from the National Heart, Lung, and Blood Institute. Most of the other statement coauthors report no disclosures outside of government funding.
SOURCE: Suglia S et al. Circulation. 2017 Dec 18. doi: 10.1161/CIR.0000000000000536
Research suggests an association between adverse childhood events and poorer cardiometabolic health across the lifespan, a new scientific statement from the American Heart Association declares, although it acknowledges various limitations in understanding the connection.
Studies haven’t confirmed a cause-and-effect relationship or the full extent of excess risk, and it’s not clear why some people who experience childhood trauma are more resilient than others. There’s also scant information about any link to higher cardiometabolic death rates.
For the new statement, which appears in Circulation, researchers reviewed recent systematic reviews into the links between childhood adversity – including events like violence and abuse – and cardiometabolic outcome.
By one estimate, nearly 60% of adults in the United States experienced at least one adverse childhood event. According to the statement, reviews have linked childhood adversity to higher risks of cardiac death and outcomes like heart attack and stroke. They’ve also linked adversity to risk factors like high blood pressure, obesity, and type 2 diabetes.
the statement said. However, Dr. Suglia noted that research into mortality is limited.
The level of higher risk varies by study and outcome, and no one knows if there’s a cause-and-effect link. “As you can imagine, child adversity is not an exposure that lends itself to randomized trials,” she said. “On top of that, we are talking about health effects that take many years to manifest so we rely on observational studies.”
However, “while there is a possibility that there is an alternate factor that is responsible for these associations, the evidence is consistent across different populations,” said Dr. Suglia of Emory University in Atlanta. “And in general, studies do consider alternative factors that may be associated with both child adversity and cardiovascular health, further strengthening inferences we can make from the observational studies.”
Why might the association exist? “The mechanisms that drive these associations are still not fully elucidated but we hypothesize three pathways that may mediate these associations: behavioral factors (diet, sleep, physical activity, smoking), biological (hypothalamic-pituitary-adrenal axis dysregulation, epigenetic, chronic inflammation), and mental health (posttraumatic stress disorder and depression),” she said.
The statement notes that research is limited into why some people thrive on the cardiometabolic front despite childhood adversity. “One of the recommendations is that we need to focus more on factors that could inform prevention and intervention efforts so that those that are affected by adversity in childhood are not also affected by adverse cardiovascular events,” Dr. Suglia said.
The statement also notes that there’s been only limited research into modifiers of vulnerability to the effects of childhood adversity, such as gender, race/ethnicity, genetics, and community characteristics. And it says there’s been little study of how early interventions may affect cardiometabolic outcomes: “Additional research, including longitudinal prospective studies, designed to guide and inform effective and timely individual/clinical and population-level preventive interventions is required.”
Dr. Suglia reports a research grant from the National Heart, Lung, and Blood Institute. Most of the other statement coauthors report no disclosures outside of government funding.
SOURCE: Suglia S et al. Circulation. 2017 Dec 18. doi: 10.1161/CIR.0000000000000536
Research suggests an association between adverse childhood events and poorer cardiometabolic health across the lifespan, a new scientific statement from the American Heart Association declares, although it acknowledges various limitations in understanding the connection.
Studies haven’t confirmed a cause-and-effect relationship or the full extent of excess risk, and it’s not clear why some people who experience childhood trauma are more resilient than others. There’s also scant information about any link to higher cardiometabolic death rates.
For the new statement, which appears in Circulation, researchers reviewed recent systematic reviews into the links between childhood adversity – including events like violence and abuse – and cardiometabolic outcome.
By one estimate, nearly 60% of adults in the United States experienced at least one adverse childhood event. According to the statement, reviews have linked childhood adversity to higher risks of cardiac death and outcomes like heart attack and stroke. They’ve also linked adversity to risk factors like high blood pressure, obesity, and type 2 diabetes.
the statement said. However, Dr. Suglia noted that research into mortality is limited.
The level of higher risk varies by study and outcome, and no one knows if there’s a cause-and-effect link. “As you can imagine, child adversity is not an exposure that lends itself to randomized trials,” she said. “On top of that, we are talking about health effects that take many years to manifest so we rely on observational studies.”
However, “while there is a possibility that there is an alternate factor that is responsible for these associations, the evidence is consistent across different populations,” said Dr. Suglia of Emory University in Atlanta. “And in general, studies do consider alternative factors that may be associated with both child adversity and cardiovascular health, further strengthening inferences we can make from the observational studies.”
Why might the association exist? “The mechanisms that drive these associations are still not fully elucidated but we hypothesize three pathways that may mediate these associations: behavioral factors (diet, sleep, physical activity, smoking), biological (hypothalamic-pituitary-adrenal axis dysregulation, epigenetic, chronic inflammation), and mental health (posttraumatic stress disorder and depression),” she said.
The statement notes that research is limited into why some people thrive on the cardiometabolic front despite childhood adversity. “One of the recommendations is that we need to focus more on factors that could inform prevention and intervention efforts so that those that are affected by adversity in childhood are not also affected by adverse cardiovascular events,” Dr. Suglia said.
The statement also notes that there’s been only limited research into modifiers of vulnerability to the effects of childhood adversity, such as gender, race/ethnicity, genetics, and community characteristics. And it says there’s been little study of how early interventions may affect cardiometabolic outcomes: “Additional research, including longitudinal prospective studies, designed to guide and inform effective and timely individual/clinical and population-level preventive interventions is required.”
Dr. Suglia reports a research grant from the National Heart, Lung, and Blood Institute. Most of the other statement coauthors report no disclosures outside of government funding.
SOURCE: Suglia S et al. Circulation. 2017 Dec 18. doi: 10.1161/CIR.0000000000000536
FROM CIRCULATION
Self-administered subcutaneous Depo-Provera ‘feasible and acceptable’
Self-administration of subcutaneous depot medroxyprogesterone acetate contraceptive is a “feasible and acceptable” alternative to clinic-based administration, according to a study published online Dec. 12 in Contraception.
Researchers randomized 401 women aged 15-44 years – who had requested depot medroxyprogesterone acetate – to four injections over the year, administered by clinic staff at one of three Planned Parenthood health centers or self-administered at home.
The self-administered group performed the first injection at the clinic under supervision, then received instructions and three doses for home use.
At the 12-month follow-up, the rates of continuous use of the contraceptive – defined as reporting two additional doses on the 6-month survey and at least one additional dose on the 12-month survey – were 69% in the self-administration group and 54% in the clinic group (P = .005).
A significantly greater proportion of women in the self-administration group reported receiving at least four shots over the study period, compared with the clinic administration group (78% vs. 64%; P = .008). The authors also noted that 64% of the self-administration group reported receiving five doses – an additional poststudy shot – compared with 52% of the clinic group.
The self-administered injection was well received by women in that group, with 97% saying it was very or somewhat easy to administer, and 87% saying they would recommend self-injection to a friend.
Around half of the participants in the clinic group said they would be interested in self-administration in the future, but both groups reported similar levels of satisfaction with the injectable contraceptive overall.
“A survey study found that women who had difficulty obtaining or refilling a prescription in the past year were almost twice as likely to be interested in self-administration compared to those without such difficulty, suggesting that self-administration has potential to reduce barriers and disparities in access to effective contraception,” wrote Julia E. Kohn, PhD, MPA, and her colleagues at Planned Parenthood. “It is important to note, however, that potential barriers related to insurance coverage and reimbursement will need to be identified and addressed for self-administration to be successfully put into practice.”
There were three pregnancies. They were in the clinic group in women who had discontinued the contraceptive, and one was a planned pregnancy. There were two reports of pain and two reports of bruising at the injection site, but no serious adverse events were reported.
While the study relied on self-report of successful injections, the authors pointed to a recent study in which all women who reported self-injections had therapeutic levels of depot medroxyprogesterone acetate confirmed by blood testing.
Tara Health Foundation supported the study. Pfizer provided the study drug through an investigator-initiated research grant. No disclosures were made.
SOURCE: Kohn JE et al. Contraception. 2017 Dec 7. doi: 10.1016/j.contraception.2017.11.009
Self-administration of subcutaneous depot medroxyprogesterone acetate contraceptive is a “feasible and acceptable” alternative to clinic-based administration, according to a study published online Dec. 12 in Contraception.
Researchers randomized 401 women aged 15-44 years – who had requested depot medroxyprogesterone acetate – to four injections over the year, administered by clinic staff at one of three Planned Parenthood health centers or self-administered at home.
The self-administered group performed the first injection at the clinic under supervision, then received instructions and three doses for home use.
At the 12-month follow-up, the rates of continuous use of the contraceptive – defined as reporting two additional doses on the 6-month survey and at least one additional dose on the 12-month survey – were 69% in the self-administration group and 54% in the clinic group (P = .005).
A significantly greater proportion of women in the self-administration group reported receiving at least four shots over the study period, compared with the clinic administration group (78% vs. 64%; P = .008). The authors also noted that 64% of the self-administration group reported receiving five doses – an additional poststudy shot – compared with 52% of the clinic group.
The self-administered injection was well received by women in that group, with 97% saying it was very or somewhat easy to administer, and 87% saying they would recommend self-injection to a friend.
Around half of the participants in the clinic group said they would be interested in self-administration in the future, but both groups reported similar levels of satisfaction with the injectable contraceptive overall.
“A survey study found that women who had difficulty obtaining or refilling a prescription in the past year were almost twice as likely to be interested in self-administration compared to those without such difficulty, suggesting that self-administration has potential to reduce barriers and disparities in access to effective contraception,” wrote Julia E. Kohn, PhD, MPA, and her colleagues at Planned Parenthood. “It is important to note, however, that potential barriers related to insurance coverage and reimbursement will need to be identified and addressed for self-administration to be successfully put into practice.”
There were three pregnancies. They were in the clinic group in women who had discontinued the contraceptive, and one was a planned pregnancy. There were two reports of pain and two reports of bruising at the injection site, but no serious adverse events were reported.
While the study relied on self-report of successful injections, the authors pointed to a recent study in which all women who reported self-injections had therapeutic levels of depot medroxyprogesterone acetate confirmed by blood testing.
Tara Health Foundation supported the study. Pfizer provided the study drug through an investigator-initiated research grant. No disclosures were made.
SOURCE: Kohn JE et al. Contraception. 2017 Dec 7. doi: 10.1016/j.contraception.2017.11.009
Self-administration of subcutaneous depot medroxyprogesterone acetate contraceptive is a “feasible and acceptable” alternative to clinic-based administration, according to a study published online Dec. 12 in Contraception.
Researchers randomized 401 women aged 15-44 years – who had requested depot medroxyprogesterone acetate – to four injections over the year, administered by clinic staff at one of three Planned Parenthood health centers or self-administered at home.
The self-administered group performed the first injection at the clinic under supervision, then received instructions and three doses for home use.
At the 12-month follow-up, the rates of continuous use of the contraceptive – defined as reporting two additional doses on the 6-month survey and at least one additional dose on the 12-month survey – were 69% in the self-administration group and 54% in the clinic group (P = .005).
A significantly greater proportion of women in the self-administration group reported receiving at least four shots over the study period, compared with the clinic administration group (78% vs. 64%; P = .008). The authors also noted that 64% of the self-administration group reported receiving five doses – an additional poststudy shot – compared with 52% of the clinic group.
The self-administered injection was well received by women in that group, with 97% saying it was very or somewhat easy to administer, and 87% saying they would recommend self-injection to a friend.
Around half of the participants in the clinic group said they would be interested in self-administration in the future, but both groups reported similar levels of satisfaction with the injectable contraceptive overall.
“A survey study found that women who had difficulty obtaining or refilling a prescription in the past year were almost twice as likely to be interested in self-administration compared to those without such difficulty, suggesting that self-administration has potential to reduce barriers and disparities in access to effective contraception,” wrote Julia E. Kohn, PhD, MPA, and her colleagues at Planned Parenthood. “It is important to note, however, that potential barriers related to insurance coverage and reimbursement will need to be identified and addressed for self-administration to be successfully put into practice.”
There were three pregnancies. They were in the clinic group in women who had discontinued the contraceptive, and one was a planned pregnancy. There were two reports of pain and two reports of bruising at the injection site, but no serious adverse events were reported.
While the study relied on self-report of successful injections, the authors pointed to a recent study in which all women who reported self-injections had therapeutic levels of depot medroxyprogesterone acetate confirmed by blood testing.
Tara Health Foundation supported the study. Pfizer provided the study drug through an investigator-initiated research grant. No disclosures were made.
SOURCE: Kohn JE et al. Contraception. 2017 Dec 7. doi: 10.1016/j.contraception.2017.11.009
FROM CONTRACEPTION
Key clinical point: Self-administration of subcutaneous depot medroxyprogesterone acetate contraceptive is a “feasible and acceptable” alternative to administration in a clinic.
Major finding: The rates of continuous use of subcutaneous depot medroxyprogesterone acetate were 69% in the self-administration group and 54% in the clinic group.
Data source: Randomized controlled trial of 401 women.
Disclosures: Tara Health Foundation supported the study. Pfizer provided the study drug through an investigator-initiated research grant. No disclosures were made.
Source: Kohn JE et al. Contraception. 2017 Dec 7. doi: 10.1016/j.contraception.2017.11.009.