Around one-half of women and one-third of men will develop dementia, stroke, or parkinsonism during their lifetime, based on results from the population-based Rotterdam study published in the Oct. 1 online edition of the Journal of Neurology, Neurosurgery & Psychiatry.

The study involved 12,102 individuals (57.7% women) who were aged 45 years or older and free from neurologic disease at baseline who were followed for 26 years.

Silvan Licher, MD, and colleagues from the University Medical Center Rotterdam (the Netherlands) found that a 45-year-old woman had a 48.2% overall remaining lifetime risk of developing dementia, stroke, or parkinsonism, while a 45-year-old man had a 36.3% lifetime risk.

“There are currently no disease-modifying drugs available for dementia and most causes of parkinsonism, and prevention of stroke is hampered by suboptimal adherence to effective preventive strategies or unmet guideline thresholds,” the authors wrote. “Yet, a delay in onset of these common neurologic diseases by merely a few years could reduce the population burden of these diseases substantially.”

Women aged 45 years had a significantly higher lifetime risk than men of developing dementia (31.4% vs. 18.6% respectively) and stroke (21.6% vs. 19.3%), but the risk of parkinsonism was similar between the sexes.

Women also had a significantly greater lifetime risk of developing more than one neurologic disease, compared with men (4% vs. 3.1%, P less than .001), largely because of the overlap between dementia and stroke.

At age 45 women had the greatest risk of dementia, but as men and women aged, their remaining lifetime risk of dementia increased relative to other neurologic diseases. After age 85 years, 66.6% of first diagnoses in women and 55.6% in men were dementia.

By comparison, first manifestation of stroke was the greatest threat to men aged 45. Men were also at a significantly higher risk for stroke at a younger age – before age 75 years – than were women (8.4% vs. 5.8%).

In the case of parkinsonism, the lifetime risk peaked earlier than it did for dementia and stroke, and was relatively low after the age of 85 years, with no significant differences in risk between men and women.

The authors also considered what effect a delay in disease onset and occurrence might have on remaining lifetime risk for neurologic disease. They found that a 1, 2, or 3-year delay in the onset of all neurologic disease was associated with a 20% reduction in lifetime risk in individuals aged 45 years or older, and a greater than 50% reduction in risk in the very oldest.

A 3-year delay in the onset of dementia reduced the lifetime risk by 15% for both men and women aged 45 years and granted a 30% reduction in risk to those aged 45 years or older.

The Rotterdam study is supported by Erasmus MC and Erasmus University Rotterdam, The Netherlands Organization for Scientific Research, The Netherlands Organization for Health Research and Development, the Research Institute for Diseases in the Elderly, The Netherlands Genomics Initiative, the Ministry of Education, Culture and Science, the Ministry of Health, Welfare and Sports, the European Commission and the Municipality of Rotterdam, the Netherlands Consortium for Healthy Ageing, and the Dutch Heart Foundation. No conflicts of interest were declared.

SOURCE: Licher S et al. JNNP. 2018 Oct 1. doi: 10.1136/jnnp-2018-318650.

Around one-half of women and one-third of men will develop dementia, stroke, or parkinsonism during their lifetime, based on results from the population-based Rotterdam study published in the Oct. 1 online edition of the Journal of Neurology, Neurosurgery & Psychiatry.

The study involved 12,102 individuals (57.7% women) who were aged 45 years or older and free from neurologic disease at baseline who were followed for 26 years.

Silvan Licher, MD, and colleagues from the University Medical Center Rotterdam (the Netherlands) found that a 45-year-old woman had a 48.2% overall remaining lifetime risk of developing dementia, stroke, or parkinsonism, while a 45-year-old man had a 36.3% lifetime risk.

“There are currently no disease-modifying drugs available for dementia and most causes of parkinsonism, and prevention of stroke is hampered by suboptimal adherence to effective preventive strategies or unmet guideline thresholds,” the authors wrote. “Yet, a delay in onset of these common neurologic diseases by merely a few years could reduce the population burden of these diseases substantially.”

Women aged 45 years had a significantly higher lifetime risk than men of developing dementia (31.4% vs. 18.6% respectively) and stroke (21.6% vs. 19.3%), but the risk of parkinsonism was similar between the sexes.

Women also had a significantly greater lifetime risk of developing more than one neurologic disease, compared with men (4% vs. 3.1%, P less than .001), largely because of the overlap between dementia and stroke.

At age 45 women had the greatest risk of dementia, but as men and women aged, their remaining lifetime risk of dementia increased relative to other neurologic diseases. After age 85 years, 66.6% of first diagnoses in women and 55.6% in men were dementia.

By comparison, first manifestation of stroke was the greatest threat to men aged 45. Men were also at a significantly higher risk for stroke at a younger age – before age 75 years – than were women (8.4% vs. 5.8%).

In the case of parkinsonism, the lifetime risk peaked earlier than it did for dementia and stroke, and was relatively low after the age of 85 years, with no significant differences in risk between men and women.

The authors also considered what effect a delay in disease onset and occurrence might have on remaining lifetime risk for neurologic disease. They found that a 1, 2, or 3-year delay in the onset of all neurologic disease was associated with a 20% reduction in lifetime risk in individuals aged 45 years or older, and a greater than 50% reduction in risk in the very oldest.

A 3-year delay in the onset of dementia reduced the lifetime risk by 15% for both men and women aged 45 years and granted a 30% reduction in risk to those aged 45 years or older.

The Rotterdam study is supported by Erasmus MC and Erasmus University Rotterdam, The Netherlands Organization for Scientific Research, The Netherlands Organization for Health Research and Development, the Research Institute for Diseases in the Elderly, The Netherlands Genomics Initiative, the Ministry of Education, Culture and Science, the Ministry of Health, Welfare and Sports, the European Commission and the Municipality of Rotterdam, the Netherlands Consortium for Healthy Ageing, and the Dutch Heart Foundation. No conflicts of interest were declared.

SOURCE: Licher S et al. JNNP. 2018 Oct 1. doi: 10.1136/jnnp-2018-318650.

Around one-half of women and one-third of men will develop dementia, stroke, or parkinsonism during their lifetime, based on results from the population-based Rotterdam study published in the Oct. 1 online edition of the Journal of Neurology, Neurosurgery & Psychiatry.

The study involved 12,102 individuals (57.7% women) who were aged 45 years or older and free from neurologic disease at baseline who were followed for 26 years.

Silvan Licher, MD, and colleagues from the University Medical Center Rotterdam (the Netherlands) found that a 45-year-old woman had a 48.2% overall remaining lifetime risk of developing dementia, stroke, or parkinsonism, while a 45-year-old man had a 36.3% lifetime risk.

“There are currently no disease-modifying drugs available for dementia and most causes of parkinsonism, and prevention of stroke is hampered by suboptimal adherence to effective preventive strategies or unmet guideline thresholds,” the authors wrote. “Yet, a delay in onset of these common neurologic diseases by merely a few years could reduce the population burden of these diseases substantially.”

Women aged 45 years had a significantly higher lifetime risk than men of developing dementia (31.4% vs. 18.6% respectively) and stroke (21.6% vs. 19.3%), but the risk of parkinsonism was similar between the sexes.

Women also had a significantly greater lifetime risk of developing more than one neurologic disease, compared with men (4% vs. 3.1%, P less than .001), largely because of the overlap between dementia and stroke.

At age 45 women had the greatest risk of dementia, but as men and women aged, their remaining lifetime risk of dementia increased relative to other neurologic diseases. After age 85 years, 66.6% of first diagnoses in women and 55.6% in men were dementia.

By comparison, first manifestation of stroke was the greatest threat to men aged 45. Men were also at a significantly higher risk for stroke at a younger age – before age 75 years – than were women (8.4% vs. 5.8%).

In the case of parkinsonism, the lifetime risk peaked earlier than it did for dementia and stroke, and was relatively low after the age of 85 years, with no significant differences in risk between men and women.

The authors also considered what effect a delay in disease onset and occurrence might have on remaining lifetime risk for neurologic disease. They found that a 1, 2, or 3-year delay in the onset of all neurologic disease was associated with a 20% reduction in lifetime risk in individuals aged 45 years or older, and a greater than 50% reduction in risk in the very oldest.

A 3-year delay in the onset of dementia reduced the lifetime risk by 15% for both men and women aged 45 years and granted a 30% reduction in risk to those aged 45 years or older.

The Rotterdam study is supported by Erasmus MC and Erasmus University Rotterdam, The Netherlands Organization for Scientific Research, The Netherlands Organization for Health Research and Development, the Research Institute for Diseases in the Elderly, The Netherlands Genomics Initiative, the Ministry of Education, Culture and Science, the Ministry of Health, Welfare and Sports, the European Commission and the Municipality of Rotterdam, the Netherlands Consortium for Healthy Ageing, and the Dutch Heart Foundation. No conflicts of interest were declared.

SOURCE: Licher S et al. JNNP. 2018 Oct 1. doi: 10.1136/jnnp-2018-318650.

If one includes the entire spectrum of venous disease, it is a more common pathology than peripheral arterial disease. The financial impact of venous disease is substantial. Why, then, has it taken so long to generate enthusiasm for venous disease of the femorocaval and subclaviocaval segments? For years, the endovascular management of venous disease used technology and techniques borrowed from the arterial space; although results were encouraging, it is clear that they varied widely and continue to do so. Management of these vascular beds is very reminiscent of the barrage of devices we have thrown at the superficial femoral artery.

In peripheral arterial disease, there have been much education and research focused on understanding atherosclerosis and its interaction with arterial devices. However, the paucity of investigation and enlightenment in the venous domain is evident when a literature search is performed. Certainly there are data from Comerota et al. showing an increased amount of collagen in the walls of chronically diseased veins. While this is a reasonable start, it is not sufficient data on which to build an entire treatment paradigm. Just like peripheral arterial disease, venous pathology presents in a continuum. Without an in-depth appreciation of the variability of those presentations, it is difficult to envision targeted therapies.

Although vendors have recently engaged in the development of venous-specific devices, it is in great part grounded in expert opinion rather than in hard data. The Medicare Evidence Development & Coverage Advisory Committee has made it known that we need more evidence on the efficacy of all venous procedures. Peter Gloviczki, MD, a vascular surgeon at Mayo Clinic, in Rochester, Minn., put it succinctly in an issue of Venous News: “We need to focus on venous research and never forget that whoever owns research owns the disease. We must continue innovation and collaboration, with other venous specialties and with industry.” Truth be told, there doesn’t seem to be much fascination with comprehension of the disease, but there appears to be an enormous drive from a variety of specialties to do procedures.

In July 2015, Gerard O’Sullivan, MD, wrote of a multidisciplinary group in Europe established to develop some standardization in venous stenting guidelines. He describes a “need for consistent guidelines for preoperative imaging, follow-up, anticoagulation duration and type, stent diameter, length into the inferior vena cava and lower end in relation to the internal iliac vein/external iliac vein.” I concur, that this would be utopic. I have not come across such guidelines to date.

Current basic science research focuses on pathologic considerations of venous thrombosis, including the consequences related to mechanical behavior of the venous wall in those conditions. In our group’s opinion, these considerations are elemental in determining the next steps in the research paradigm. What determines the remodeling of a vein, with or without intervention? How does a stent influence remodeling? Not surprisingly there are numerous questions that remain unanswered.

Translational investigation has provided insight into innovative ways to use computed tomography and magnetic resonance imaging. The ability to stage venous disease noninvasively could have a profound impact on how and why we manage the pathology. Additionally, knowing what the pathology looks like and potentially behaves like has the potential to promote more appropriate therapies. Intravascular ultrasound is well described by users and essential to the management of venous disease as it allows us to visualize and appreciate the pathology being treated in real time.

IVUS, though, is primarily used in the context of delivering a therapeutic tool as well as being invasive. Until recently, we have not been able to bring the power of cross-sectional imaging into the operative space. Our group has published on the use of multimodal imaging techniques such as magnetic resonance venography and fluoroscopic image fusion, which can potentially guide future interventions and optimize therapeutic decision-making.

Ultimately, we believe that diseased veins behave differently than arteries do. Therefore, managing veins with tools meant for another space is likely not ideal. Many venous interventions use arterial devices that are not optimized for venous pathologies and underline the fact that we need to continue to develop tools specifically designed for the venous space. The ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) trial has been extremely impactful in the treatment paradigm of venous thrombosis. Although the results remain heavily debated and, on some level, contested, it is a critical trial and should – in many ways – serve as an example of the good research being executed in venous disease.

A quote many have attributed to Albert Einstein says: “The one who follows the crowd will usually go no further than the crowd. Those who walk alone are likely to find themselves in places no one has ever been before.” We have an opportunity to be more enlightened with respect to central venous therapies; let’s not act like lemmings and follow one another off the cliff.

Dr. Bismuth is an associate professor of surgery and associate program director, Houston Methodist Hospital. He reported that he had no relevant disclosures.

References

Comerota AJ et al. 2015 May. Thromb Res. 135(5):882-7.

Vedantham S et al. 2017 Dec 7. N Engl J Med. 377(23):2240-52.

O’Sullivan G 2015 Jul. Endovascular Today.14;7:60-2.

Gloviczki P 2017 Apr. Venous News.1:8.














 

If one includes the entire spectrum of venous disease, it is a more common pathology than peripheral arterial disease. The financial impact of venous disease is substantial. Why, then, has it taken so long to generate enthusiasm for venous disease of the femorocaval and subclaviocaval segments? For years, the endovascular management of venous disease used technology and techniques borrowed from the arterial space; although results were encouraging, it is clear that they varied widely and continue to do so. Management of these vascular beds is very reminiscent of the barrage of devices we have thrown at the superficial femoral artery.

In peripheral arterial disease, there have been much education and research focused on understanding atherosclerosis and its interaction with arterial devices. However, the paucity of investigation and enlightenment in the venous domain is evident when a literature search is performed. Certainly there are data from Comerota et al. showing an increased amount of collagen in the walls of chronically diseased veins. While this is a reasonable start, it is not sufficient data on which to build an entire treatment paradigm. Just like peripheral arterial disease, venous pathology presents in a continuum. Without an in-depth appreciation of the variability of those presentations, it is difficult to envision targeted therapies.

Although vendors have recently engaged in the development of venous-specific devices, it is in great part grounded in expert opinion rather than in hard data. The Medicare Evidence Development & Coverage Advisory Committee has made it known that we need more evidence on the efficacy of all venous procedures. Peter Gloviczki, MD, a vascular surgeon at Mayo Clinic, in Rochester, Minn., put it succinctly in an issue of Venous News: “We need to focus on venous research and never forget that whoever owns research owns the disease. We must continue innovation and collaboration, with other venous specialties and with industry.” Truth be told, there doesn’t seem to be much fascination with comprehension of the disease, but there appears to be an enormous drive from a variety of specialties to do procedures.

In July 2015, Gerard O’Sullivan, MD, wrote of a multidisciplinary group in Europe established to develop some standardization in venous stenting guidelines. He describes a “need for consistent guidelines for preoperative imaging, follow-up, anticoagulation duration and type, stent diameter, length into the inferior vena cava and lower end in relation to the internal iliac vein/external iliac vein.” I concur, that this would be utopic. I have not come across such guidelines to date.

Current basic science research focuses on pathologic considerations of venous thrombosis, including the consequences related to mechanical behavior of the venous wall in those conditions. In our group’s opinion, these considerations are elemental in determining the next steps in the research paradigm. What determines the remodeling of a vein, with or without intervention? How does a stent influence remodeling? Not surprisingly there are numerous questions that remain unanswered.

Translational investigation has provided insight into innovative ways to use computed tomography and magnetic resonance imaging. The ability to stage venous disease noninvasively could have a profound impact on how and why we manage the pathology. Additionally, knowing what the pathology looks like and potentially behaves like has the potential to promote more appropriate therapies. Intravascular ultrasound is well described by users and essential to the management of venous disease as it allows us to visualize and appreciate the pathology being treated in real time.

IVUS, though, is primarily used in the context of delivering a therapeutic tool as well as being invasive. Until recently, we have not been able to bring the power of cross-sectional imaging into the operative space. Our group has published on the use of multimodal imaging techniques such as magnetic resonance venography and fluoroscopic image fusion, which can potentially guide future interventions and optimize therapeutic decision-making.

Ultimately, we believe that diseased veins behave differently than arteries do. Therefore, managing veins with tools meant for another space is likely not ideal. Many venous interventions use arterial devices that are not optimized for venous pathologies and underline the fact that we need to continue to develop tools specifically designed for the venous space. The ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) trial has been extremely impactful in the treatment paradigm of venous thrombosis. Although the results remain heavily debated and, on some level, contested, it is a critical trial and should – in many ways – serve as an example of the good research being executed in venous disease.

A quote many have attributed to Albert Einstein says: “The one who follows the crowd will usually go no further than the crowd. Those who walk alone are likely to find themselves in places no one has ever been before.” We have an opportunity to be more enlightened with respect to central venous therapies; let’s not act like lemmings and follow one another off the cliff.

Dr. Bismuth is an associate professor of surgery and associate program director, Houston Methodist Hospital. He reported that he had no relevant disclosures.

References

Comerota AJ et al. 2015 May. Thromb Res. 135(5):882-7.

Vedantham S et al. 2017 Dec 7. N Engl J Med. 377(23):2240-52.

O’Sullivan G 2015 Jul. Endovascular Today.14;7:60-2.

Gloviczki P 2017 Apr. Venous News.1:8.














 

If one includes the entire spectrum of venous disease, it is a more common pathology than peripheral arterial disease. The financial impact of venous disease is substantial. Why, then, has it taken so long to generate enthusiasm for venous disease of the femorocaval and subclaviocaval segments? For years, the endovascular management of venous disease used technology and techniques borrowed from the arterial space; although results were encouraging, it is clear that they varied widely and continue to do so. Management of these vascular beds is very reminiscent of the barrage of devices we have thrown at the superficial femoral artery.

In peripheral arterial disease, there have been much education and research focused on understanding atherosclerosis and its interaction with arterial devices. However, the paucity of investigation and enlightenment in the venous domain is evident when a literature search is performed. Certainly there are data from Comerota et al. showing an increased amount of collagen in the walls of chronically diseased veins. While this is a reasonable start, it is not sufficient data on which to build an entire treatment paradigm. Just like peripheral arterial disease, venous pathology presents in a continuum. Without an in-depth appreciation of the variability of those presentations, it is difficult to envision targeted therapies.

Although vendors have recently engaged in the development of venous-specific devices, it is in great part grounded in expert opinion rather than in hard data. The Medicare Evidence Development & Coverage Advisory Committee has made it known that we need more evidence on the efficacy of all venous procedures. Peter Gloviczki, MD, a vascular surgeon at Mayo Clinic, in Rochester, Minn., put it succinctly in an issue of Venous News: “We need to focus on venous research and never forget that whoever owns research owns the disease. We must continue innovation and collaboration, with other venous specialties and with industry.” Truth be told, there doesn’t seem to be much fascination with comprehension of the disease, but there appears to be an enormous drive from a variety of specialties to do procedures.

In July 2015, Gerard O’Sullivan, MD, wrote of a multidisciplinary group in Europe established to develop some standardization in venous stenting guidelines. He describes a “need for consistent guidelines for preoperative imaging, follow-up, anticoagulation duration and type, stent diameter, length into the inferior vena cava and lower end in relation to the internal iliac vein/external iliac vein.” I concur, that this would be utopic. I have not come across such guidelines to date.

Current basic science research focuses on pathologic considerations of venous thrombosis, including the consequences related to mechanical behavior of the venous wall in those conditions. In our group’s opinion, these considerations are elemental in determining the next steps in the research paradigm. What determines the remodeling of a vein, with or without intervention? How does a stent influence remodeling? Not surprisingly there are numerous questions that remain unanswered.

Translational investigation has provided insight into innovative ways to use computed tomography and magnetic resonance imaging. The ability to stage venous disease noninvasively could have a profound impact on how and why we manage the pathology. Additionally, knowing what the pathology looks like and potentially behaves like has the potential to promote more appropriate therapies. Intravascular ultrasound is well described by users and essential to the management of venous disease as it allows us to visualize and appreciate the pathology being treated in real time.

IVUS, though, is primarily used in the context of delivering a therapeutic tool as well as being invasive. Until recently, we have not been able to bring the power of cross-sectional imaging into the operative space. Our group has published on the use of multimodal imaging techniques such as magnetic resonance venography and fluoroscopic image fusion, which can potentially guide future interventions and optimize therapeutic decision-making.

Ultimately, we believe that diseased veins behave differently than arteries do. Therefore, managing veins with tools meant for another space is likely not ideal. Many venous interventions use arterial devices that are not optimized for venous pathologies and underline the fact that we need to continue to develop tools specifically designed for the venous space. The ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) trial has been extremely impactful in the treatment paradigm of venous thrombosis. Although the results remain heavily debated and, on some level, contested, it is a critical trial and should – in many ways – serve as an example of the good research being executed in venous disease.

A quote many have attributed to Albert Einstein says: “The one who follows the crowd will usually go no further than the crowd. Those who walk alone are likely to find themselves in places no one has ever been before.” We have an opportunity to be more enlightened with respect to central venous therapies; let’s not act like lemmings and follow one another off the cliff.

Dr. Bismuth is an associate professor of surgery and associate program director, Houston Methodist Hospital. He reported that he had no relevant disclosures.

References

Comerota AJ et al. 2015 May. Thromb Res. 135(5):882-7.

Vedantham S et al. 2017 Dec 7. N Engl J Med. 377(23):2240-52.

O’Sullivan G 2015 Jul. Endovascular Today.14;7:60-2.

Gloviczki P 2017 Apr. Venous News.1:8.














 

For patients who undergo allogeneic hematopoietic stem cell transplant (allo-HSCT) with intensive antibiotics, a subsequent autologous fecal transplant (auto-FMT) can restore intestinal microbiota, a recent study found.

Courtesy Memorial Sloan Kettering Cancer Center

Loss of normal gut bacteria after allo-HSCT and antibiotics is a common occurrence and known risk factor for graft-versus-host disease (GVHD) and intestinal infection.

“Overall, patients who lose gut microbiota diversity at the time of hematopoietic stem cell engraftment have higher rates of transplant-related death,” reported Ying Taur, MD, of the Memorial Sloan Kettering Cancer Center in New York, and his colleagues. “We explored whether the microbiota could be restored in allo-HSCT patients through the use of auto-FMT.”

Allo-HSCT patients are immune suppressed for months after engraftment, so safety concerns led the investigators to use auto-FMT rather than a fecal transplant from another individual. The complex population of viruses, fungi, archaea, bacteria, and protozoa that inhabit the human gut remains poorly understood, as does the infectious potential of a heterologous fecal donor.

“Despite remarkable advances in recent years, current technologies are incapable of comprehensively determining fecal composition,” the authors wrote in Science Translational Medicine.

The study involved 25 patients undergoing allo-HSCT with intensive antibiotic therapy. Prior to engraftment, fecal samples were collected from all patients and analyzed for composition and diversity, measured by inverse Simpson index.

Samples were then frozen and stored. Fecal analysis also was performed after engraftment, and again after the auto-FMT time point. Auto-FMT was performed in 14 patients; 11 patients served as controls and did not receive treatment. Patients were followed for 1 year.

The investigators found that all of the patients who underwent auto-FMT recovered their pre–allo-HSCT microbiota composition and diversity, compared with none of the controls (P less than .0001). Further analysis showed that auto-FMT increased diversity (inverse Simpson index) by 64%, compared with 38% in controls.

“We have demonstrated the potential of auto-FMT as a clinical intervention to restore intestinal microbiota diversity to levels deemed safe in patients, thereby reversing the disruptive effects of broad-spectrum antibiotic treatment for patients undergoing allo-HSCT transplant,” the investigators concluded.

Study funding was provided by the Leonard Tow Foundation and the Memorial Sloan Kettering’s Center for Microbes, Inflammation, and Cancer. The authors reported financial relationships with Merck, AbbVie, Nektar Therapeutics, Novartis, and others.

If you perform fecal microbiota transplantation (FMT), learn more about how you can get involved with the AGA FMT National Registry at http://ow.ly/ke1L30m35fj.

SOURCE: Taur Y et al. Sci Transl Med. 2018 Sep 26. doi: 10.1126/scitranslmed.aap9489.

For patients who undergo allogeneic hematopoietic stem cell transplant (allo-HSCT) with intensive antibiotics, a subsequent autologous fecal transplant (auto-FMT) can restore intestinal microbiota, a recent study found.

Courtesy Memorial Sloan Kettering Cancer Center

Loss of normal gut bacteria after allo-HSCT and antibiotics is a common occurrence and known risk factor for graft-versus-host disease (GVHD) and intestinal infection.

“Overall, patients who lose gut microbiota diversity at the time of hematopoietic stem cell engraftment have higher rates of transplant-related death,” reported Ying Taur, MD, of the Memorial Sloan Kettering Cancer Center in New York, and his colleagues. “We explored whether the microbiota could be restored in allo-HSCT patients through the use of auto-FMT.”

Allo-HSCT patients are immune suppressed for months after engraftment, so safety concerns led the investigators to use auto-FMT rather than a fecal transplant from another individual. The complex population of viruses, fungi, archaea, bacteria, and protozoa that inhabit the human gut remains poorly understood, as does the infectious potential of a heterologous fecal donor.

“Despite remarkable advances in recent years, current technologies are incapable of comprehensively determining fecal composition,” the authors wrote in Science Translational Medicine.

The study involved 25 patients undergoing allo-HSCT with intensive antibiotic therapy. Prior to engraftment, fecal samples were collected from all patients and analyzed for composition and diversity, measured by inverse Simpson index.

Samples were then frozen and stored. Fecal analysis also was performed after engraftment, and again after the auto-FMT time point. Auto-FMT was performed in 14 patients; 11 patients served as controls and did not receive treatment. Patients were followed for 1 year.

The investigators found that all of the patients who underwent auto-FMT recovered their pre–allo-HSCT microbiota composition and diversity, compared with none of the controls (P less than .0001). Further analysis showed that auto-FMT increased diversity (inverse Simpson index) by 64%, compared with 38% in controls.

“We have demonstrated the potential of auto-FMT as a clinical intervention to restore intestinal microbiota diversity to levels deemed safe in patients, thereby reversing the disruptive effects of broad-spectrum antibiotic treatment for patients undergoing allo-HSCT transplant,” the investigators concluded.

Study funding was provided by the Leonard Tow Foundation and the Memorial Sloan Kettering’s Center for Microbes, Inflammation, and Cancer. The authors reported financial relationships with Merck, AbbVie, Nektar Therapeutics, Novartis, and others.

If you perform fecal microbiota transplantation (FMT), learn more about how you can get involved with the AGA FMT National Registry at http://ow.ly/ke1L30m35fj.

SOURCE: Taur Y et al. Sci Transl Med. 2018 Sep 26. doi: 10.1126/scitranslmed.aap9489.

For patients who undergo allogeneic hematopoietic stem cell transplant (allo-HSCT) with intensive antibiotics, a subsequent autologous fecal transplant (auto-FMT) can restore intestinal microbiota, a recent study found.

Courtesy Memorial Sloan Kettering Cancer Center

Loss of normal gut bacteria after allo-HSCT and antibiotics is a common occurrence and known risk factor for graft-versus-host disease (GVHD) and intestinal infection.

“Overall, patients who lose gut microbiota diversity at the time of hematopoietic stem cell engraftment have higher rates of transplant-related death,” reported Ying Taur, MD, of the Memorial Sloan Kettering Cancer Center in New York, and his colleagues. “We explored whether the microbiota could be restored in allo-HSCT patients through the use of auto-FMT.”

Allo-HSCT patients are immune suppressed for months after engraftment, so safety concerns led the investigators to use auto-FMT rather than a fecal transplant from another individual. The complex population of viruses, fungi, archaea, bacteria, and protozoa that inhabit the human gut remains poorly understood, as does the infectious potential of a heterologous fecal donor.

“Despite remarkable advances in recent years, current technologies are incapable of comprehensively determining fecal composition,” the authors wrote in Science Translational Medicine.

The study involved 25 patients undergoing allo-HSCT with intensive antibiotic therapy. Prior to engraftment, fecal samples were collected from all patients and analyzed for composition and diversity, measured by inverse Simpson index.

Samples were then frozen and stored. Fecal analysis also was performed after engraftment, and again after the auto-FMT time point. Auto-FMT was performed in 14 patients; 11 patients served as controls and did not receive treatment. Patients were followed for 1 year.

The investigators found that all of the patients who underwent auto-FMT recovered their pre–allo-HSCT microbiota composition and diversity, compared with none of the controls (P less than .0001). Further analysis showed that auto-FMT increased diversity (inverse Simpson index) by 64%, compared with 38% in controls.

“We have demonstrated the potential of auto-FMT as a clinical intervention to restore intestinal microbiota diversity to levels deemed safe in patients, thereby reversing the disruptive effects of broad-spectrum antibiotic treatment for patients undergoing allo-HSCT transplant,” the investigators concluded.

Study funding was provided by the Leonard Tow Foundation and the Memorial Sloan Kettering’s Center for Microbes, Inflammation, and Cancer. The authors reported financial relationships with Merck, AbbVie, Nektar Therapeutics, Novartis, and others.

If you perform fecal microbiota transplantation (FMT), learn more about how you can get involved with the AGA FMT National Registry at http://ow.ly/ke1L30m35fj.

SOURCE: Taur Y et al. Sci Transl Med. 2018 Sep 26. doi: 10.1126/scitranslmed.aap9489.

The Diagnosis: Cutaneous Metastases

Cutaneous metastases (CMs) can present in an otherwise asymptomatic patient as the only sign of an underlying disease process. In women, the most common cause of CM is breast carcinoma.^1-3 Cutaneous metastases are found in approximately 25% of all patients with breast carcinoma,¹ and breast carcinomas represent approximately 69% of all CMs found in women (Table 1).² Cutaneous metastatic breast carcinoma (CMBC) is associated with a poor prognosis with a mean survival of approximately 6 months at the time of diagnosis.^1,3 It commonly presents as a collection of flesh-colored, firm, asymptomatic, and rapidly appearing papules and nodules that can resemble cysts or fibrous tumors.^1,3,4 They typically are located on the chest wall or abdomen near the site of the underlying malignancy.^1-3 The histologic features of CMBC can include hyperchromatic tumor cells infiltrating between the collagen fibers in a characteristic single file manner,^3,5 giving the appearance of a busy dermis, a nonspecific term to describe a focally hypercellular dermis at low-power magnification (Table 2).^5,6 Cords and clusters of atypical cells with intracytoplasmic vacuoles or well-developed ducts also can be seen (quiz image [inset]). The carcinoma en cuirasse subtype of CMBC is characterized by a fibrotic scarlike plaque on the chest wall.^1,3 If a punch biopsy is obtained, the specimen typically appears rectangular rather than tapered because of the sclerotic dermal collagen.⁶ In contrast, inflammatory carcinoma (carcinoma erysipelatoides) presents as an erythematous plaque resembling cellulitis due to the lymphatics being congested by tumor cells.³ Immunohistochemistry is a valuable tool in diagnosis. Positive staining is seen with cytokeratin 7, gross cystic disease fluid protein-15, mammaglobin, and GATA-3.^1,3,6

Kaposi sarcoma (KS) is a low-grade endothelial malignancy associated with human herpesvirus 8.^3,4 Kaposi sarcoma can be divided into 4 main subtypes: classic KS, African KS, AIDS-related KS, and immunosuppression-associated KS that occurs in patients with diseases such as human immunodeficiency virus. The cutaneous lesions are similar between subtypes and present as dark reddish purple macules that may enlarge or become nodular lesions.^3,4 Histologically, 3 distinct stages of progression are described: patch, plaque, and tumor. The plaque stage has the appearance of a busy dermis due to the rapid proliferation of vascular structures within the dermis.^3,6 A useful histologic feature known as the promontory sign can be seen as the proliferating tumor causes preexisting structures to project into vascular spaces (Figure 1).⁶ Immunohistochemistry for the endothelial and lymphatic markers CD31 and D2-40, respectively, are positive and may aid in the diagnosis.³ Staining for the latent nuclear antigen-1 of human herpesvirus 8 is a highly specific marker used to diagnose KS and can further distinguish it from the other busy dermis lesions.³ 

Granuloma annulare (GA) is characterized by rings of small, firm, pink to flesh-colored papules with a variable disease duration.⁴ Histologically, the interstitial variant of GA is characterized by a scattered inflammatory infiltrate consisting of histiocytes and lymphocytes located between altered collagen fibers in the superficial to mid dermis (Figure 2).^3,6 Occasional eosinophils and increased dermal mucin are useful features to distinguish interstitial GA from other entities in the busy dermis differential.⁷

Scleromyxedema, also known as generalized lichen myxedematosus, is a rare mucinosis.^3,8 Although its pathogenesis is unknown, it has been suggested that paraproteins related to the underlying gammopathy act to stimulate fibroblast proliferation and mucin overproduction.⁸ Clinically, characteristic widespread firm, waxy, dome-shaped papules are present over the head, upper trunk, and extremities.^3,8 Histologically, scleromyxedema is characterized by increased dermal fibroblasts, mucin, and fibrosis, leading to the appearance of a busy dermis (Figure 3).^3,6

Neurofibromas are common benign peripheral nerve sheath tumors that can occur sporadically or in the setting of neurofibromatosis.^3-5 They present as soft, flesh-colored papules or nodules most commonly located on the trunk and limbs.⁴ Histologically, neurofibromas are nonencapsulated tumors composed of abundant spindle cells with comma-shaped nuclei diffusely arranged in a pale myxoid stroma (Figure 4). Scattered mast cells can be visualized at higher magnification.^3,6

The Diagnosis: Cutaneous Metastases

Cutaneous metastases (CMs) can present in an otherwise asymptomatic patient as the only sign of an underlying disease process. In women, the most common cause of CM is breast carcinoma.^1-3 Cutaneous metastases are found in approximately 25% of all patients with breast carcinoma,¹ and breast carcinomas represent approximately 69% of all CMs found in women (Table 1).² Cutaneous metastatic breast carcinoma (CMBC) is associated with a poor prognosis with a mean survival of approximately 6 months at the time of diagnosis.^1,3 It commonly presents as a collection of flesh-colored, firm, asymptomatic, and rapidly appearing papules and nodules that can resemble cysts or fibrous tumors.^1,3,4 They typically are located on the chest wall or abdomen near the site of the underlying malignancy.^1-3 The histologic features of CMBC can include hyperchromatic tumor cells infiltrating between the collagen fibers in a characteristic single file manner,^3,5 giving the appearance of a busy dermis, a nonspecific term to describe a focally hypercellular dermis at low-power magnification (Table 2).^5,6 Cords and clusters of atypical cells with intracytoplasmic vacuoles or well-developed ducts also can be seen (quiz image [inset]). The carcinoma en cuirasse subtype of CMBC is characterized by a fibrotic scarlike plaque on the chest wall.^1,3 If a punch biopsy is obtained, the specimen typically appears rectangular rather than tapered because of the sclerotic dermal collagen.⁶ In contrast, inflammatory carcinoma (carcinoma erysipelatoides) presents as an erythematous plaque resembling cellulitis due to the lymphatics being congested by tumor cells.³ Immunohistochemistry is a valuable tool in diagnosis. Positive staining is seen with cytokeratin 7, gross cystic disease fluid protein-15, mammaglobin, and GATA-3.^1,3,6

Kaposi sarcoma (KS) is a low-grade endothelial malignancy associated with human herpesvirus 8.^3,4 Kaposi sarcoma can be divided into 4 main subtypes: classic KS, African KS, AIDS-related KS, and immunosuppression-associated KS that occurs in patients with diseases such as human immunodeficiency virus. The cutaneous lesions are similar between subtypes and present as dark reddish purple macules that may enlarge or become nodular lesions.^3,4 Histologically, 3 distinct stages of progression are described: patch, plaque, and tumor. The plaque stage has the appearance of a busy dermis due to the rapid proliferation of vascular structures within the dermis.^3,6 A useful histologic feature known as the promontory sign can be seen as the proliferating tumor causes preexisting structures to project into vascular spaces (Figure 1).⁶ Immunohistochemistry for the endothelial and lymphatic markers CD31 and D2-40, respectively, are positive and may aid in the diagnosis.³ Staining for the latent nuclear antigen-1 of human herpesvirus 8 is a highly specific marker used to diagnose KS and can further distinguish it from the other busy dermis lesions.³ 

Granuloma annulare (GA) is characterized by rings of small, firm, pink to flesh-colored papules with a variable disease duration.⁴ Histologically, the interstitial variant of GA is characterized by a scattered inflammatory infiltrate consisting of histiocytes and lymphocytes located between altered collagen fibers in the superficial to mid dermis (Figure 2).^3,6 Occasional eosinophils and increased dermal mucin are useful features to distinguish interstitial GA from other entities in the busy dermis differential.⁷

Scleromyxedema, also known as generalized lichen myxedematosus, is a rare mucinosis.^3,8 Although its pathogenesis is unknown, it has been suggested that paraproteins related to the underlying gammopathy act to stimulate fibroblast proliferation and mucin overproduction.⁸ Clinically, characteristic widespread firm, waxy, dome-shaped papules are present over the head, upper trunk, and extremities.^3,8 Histologically, scleromyxedema is characterized by increased dermal fibroblasts, mucin, and fibrosis, leading to the appearance of a busy dermis (Figure 3).^3,6

Neurofibromas are common benign peripheral nerve sheath tumors that can occur sporadically or in the setting of neurofibromatosis.^3-5 They present as soft, flesh-colored papules or nodules most commonly located on the trunk and limbs.⁴ Histologically, neurofibromas are nonencapsulated tumors composed of abundant spindle cells with comma-shaped nuclei diffusely arranged in a pale myxoid stroma (Figure 4). Scattered mast cells can be visualized at higher magnification.^3,6

The Diagnosis: Cutaneous Metastases

Cutaneous metastases (CMs) can present in an otherwise asymptomatic patient as the only sign of an underlying disease process. In women, the most common cause of CM is breast carcinoma.^1-3 Cutaneous metastases are found in approximately 25% of all patients with breast carcinoma,¹ and breast carcinomas represent approximately 69% of all CMs found in women (Table 1).² Cutaneous metastatic breast carcinoma (CMBC) is associated with a poor prognosis with a mean survival of approximately 6 months at the time of diagnosis.^1,3 It commonly presents as a collection of flesh-colored, firm, asymptomatic, and rapidly appearing papules and nodules that can resemble cysts or fibrous tumors.^1,3,4 They typically are located on the chest wall or abdomen near the site of the underlying malignancy.^1-3 The histologic features of CMBC can include hyperchromatic tumor cells infiltrating between the collagen fibers in a characteristic single file manner,^3,5 giving the appearance of a busy dermis, a nonspecific term to describe a focally hypercellular dermis at low-power magnification (Table 2).^5,6 Cords and clusters of atypical cells with intracytoplasmic vacuoles or well-developed ducts also can be seen (quiz image [inset]). The carcinoma en cuirasse subtype of CMBC is characterized by a fibrotic scarlike plaque on the chest wall.^1,3 If a punch biopsy is obtained, the specimen typically appears rectangular rather than tapered because of the sclerotic dermal collagen.⁶ In contrast, inflammatory carcinoma (carcinoma erysipelatoides) presents as an erythematous plaque resembling cellulitis due to the lymphatics being congested by tumor cells.³ Immunohistochemistry is a valuable tool in diagnosis. Positive staining is seen with cytokeratin 7, gross cystic disease fluid protein-15, mammaglobin, and GATA-3.^1,3,6

Kaposi sarcoma (KS) is a low-grade endothelial malignancy associated with human herpesvirus 8.^3,4 Kaposi sarcoma can be divided into 4 main subtypes: classic KS, African KS, AIDS-related KS, and immunosuppression-associated KS that occurs in patients with diseases such as human immunodeficiency virus. The cutaneous lesions are similar between subtypes and present as dark reddish purple macules that may enlarge or become nodular lesions.^3,4 Histologically, 3 distinct stages of progression are described: patch, plaque, and tumor. The plaque stage has the appearance of a busy dermis due to the rapid proliferation of vascular structures within the dermis.^3,6 A useful histologic feature known as the promontory sign can be seen as the proliferating tumor causes preexisting structures to project into vascular spaces (Figure 1).⁶ Immunohistochemistry for the endothelial and lymphatic markers CD31 and D2-40, respectively, are positive and may aid in the diagnosis.³ Staining for the latent nuclear antigen-1 of human herpesvirus 8 is a highly specific marker used to diagnose KS and can further distinguish it from the other busy dermis lesions.³ 

Granuloma annulare (GA) is characterized by rings of small, firm, pink to flesh-colored papules with a variable disease duration.⁴ Histologically, the interstitial variant of GA is characterized by a scattered inflammatory infiltrate consisting of histiocytes and lymphocytes located between altered collagen fibers in the superficial to mid dermis (Figure 2).^3,6 Occasional eosinophils and increased dermal mucin are useful features to distinguish interstitial GA from other entities in the busy dermis differential.⁷

Scleromyxedema, also known as generalized lichen myxedematosus, is a rare mucinosis.^3,8 Although its pathogenesis is unknown, it has been suggested that paraproteins related to the underlying gammopathy act to stimulate fibroblast proliferation and mucin overproduction.⁸ Clinically, characteristic widespread firm, waxy, dome-shaped papules are present over the head, upper trunk, and extremities.^3,8 Histologically, scleromyxedema is characterized by increased dermal fibroblasts, mucin, and fibrosis, leading to the appearance of a busy dermis (Figure 3).^3,6

Neurofibromas are common benign peripheral nerve sheath tumors that can occur sporadically or in the setting of neurofibromatosis.^3-5 They present as soft, flesh-colored papules or nodules most commonly located on the trunk and limbs.⁴ Histologically, neurofibromas are nonencapsulated tumors composed of abundant spindle cells with comma-shaped nuclei diffusely arranged in a pale myxoid stroma (Figure 4). Scattered mast cells can be visualized at higher magnification.^3,6

ATLANTA – Postlicensure surveillance of a trivalent adjuvanted influenza vaccine approved in 2015 for adults aged 65 years and older revealed no new or unexpected patterns of adverse events, according to an analysis of reports to the Vaccine Adverse Event Reporting System (VAERS) during July 2016 through March 2018.

Wavebreakmedia/Thinkstock

VAERS received 630 reports related to the vaccine (aIIV3; FLUAD) during the study period, of which 521 involved adults aged 65 years and older.

“Eighteen (3%) were serious reports, including two death reports (0.4%), all in adults aged [at least] 65 years,” Penina Haber and her colleagues at the Immunization Safety Office at the Centers for Disease Control and Prevention reported in a poster at the International Conference on Emerging Infectious Diseases.

The deaths included a 75-year-old man who died from Sjögren’s syndrome and a 65-year-old man who died from a myocardial infarction. The other serious events included five neurologic disorders (two cases of Guillain-Barré syndrome and one each of Bell’s palsy, Bickerstaff encephalitis, and lower-extremity weakness), five musculoskeletal and connective tissue disorders (three with shoulder pain and two with arm pain), three general disorders and administration site conditions (two cases of fever/chills and one case of cellulitis/bursitis), and one case each of a gastrointestinal disorder (acute diarrhea/gastroenteritis), an injury (a fall), and a skin/subcutaneous tissue disorder (keratosis pilaris rubra), according to the investigators.

There were no reports of anaphylaxis.

For the sake of comparison, the investigators also looked at reports associated with IIV3-HD and IIV3/IIV4 vaccines in adults aged 65 years and older during the same time period; they found that patient characteristics and reported events were similar for all the vaccines. For example, the percentages of reports involving patients aged 65 years and older were 65% or 66% for each, and those involving patients aged 75-84 years were 27%-29%. Further, 0.2%-0.6% of reports for each vaccine involved death.

The most frequently reported events for aIIV3, IIV3-HD, and IIV3/IIV4, respectively, were extremity pain (21%, 17%, and 15%, respectively), injection site erythema (18%, 19%, and 15%), and injection site pain (15%, 16%, and 16%), they said.

The aIIV3 vaccine – the first seasonal inactivated trivalent influenza vaccine produced from three influenza virus strains (two subtype A strains and one type B strain) – was approved by the Food and Drug Administration in 2015 for adults aged 65 years and older. It was the first influenza vaccine containing the adjuvant MF59 – a purified oil-in-water emulsion of squalene oil added to boost immune response in that population. Its safety was assessed in 15 randomized, controlled clinical studies, and several trials in older adults supported its efficacy and safety over nonadjuvanted influenza vaccines, the investigators reported. They noted that the Advisory Committee on Immunization Practices (ACIP) recommended the vaccine as an option for routine use in adults aged 65 years and older during the 2016-2017 flu seasons.

For the 2018-2019 flu season, ACIP determined that “For persons aged ≥65 years, any age-appropriate IIV formulation (standard-dose or high-dose, trivalent or quadrivalent, unadjuvanted or adjuvanted) or RIV4 are acceptable options.”

The findings of the analysis of the 2017-2018 flu season data are consistent with prelicensure studies, Ms. Haber and her colleagues concluded, noting that data mining did not detect disproportional reporting of any unexpected adverse event.

“[There were] no safety concerns following aIIV3 when compared to the nonadjuvanted influenza vaccines (IIV3-HD or IIV3/IIV4),” they wrote, adding that the “CDC and FDA will continue to monitor and ensure the safety of aIIV3.”

Ms. Haber reported having no disclosures

[email protected]

SOURCE: Haber P et al. ICEID 2018, Board 320.

ATLANTA – Postlicensure surveillance of a trivalent adjuvanted influenza vaccine approved in 2015 for adults aged 65 years and older revealed no new or unexpected patterns of adverse events, according to an analysis of reports to the Vaccine Adverse Event Reporting System (VAERS) during July 2016 through March 2018.

Wavebreakmedia/Thinkstock

VAERS received 630 reports related to the vaccine (aIIV3; FLUAD) during the study period, of which 521 involved adults aged 65 years and older.

“Eighteen (3%) were serious reports, including two death reports (0.4%), all in adults aged [at least] 65 years,” Penina Haber and her colleagues at the Immunization Safety Office at the Centers for Disease Control and Prevention reported in a poster at the International Conference on Emerging Infectious Diseases.

The deaths included a 75-year-old man who died from Sjögren’s syndrome and a 65-year-old man who died from a myocardial infarction. The other serious events included five neurologic disorders (two cases of Guillain-Barré syndrome and one each of Bell’s palsy, Bickerstaff encephalitis, and lower-extremity weakness), five musculoskeletal and connective tissue disorders (three with shoulder pain and two with arm pain), three general disorders and administration site conditions (two cases of fever/chills and one case of cellulitis/bursitis), and one case each of a gastrointestinal disorder (acute diarrhea/gastroenteritis), an injury (a fall), and a skin/subcutaneous tissue disorder (keratosis pilaris rubra), according to the investigators.

There were no reports of anaphylaxis.

For the sake of comparison, the investigators also looked at reports associated with IIV3-HD and IIV3/IIV4 vaccines in adults aged 65 years and older during the same time period; they found that patient characteristics and reported events were similar for all the vaccines. For example, the percentages of reports involving patients aged 65 years and older were 65% or 66% for each, and those involving patients aged 75-84 years were 27%-29%. Further, 0.2%-0.6% of reports for each vaccine involved death.

The most frequently reported events for aIIV3, IIV3-HD, and IIV3/IIV4, respectively, were extremity pain (21%, 17%, and 15%, respectively), injection site erythema (18%, 19%, and 15%), and injection site pain (15%, 16%, and 16%), they said.

The aIIV3 vaccine – the first seasonal inactivated trivalent influenza vaccine produced from three influenza virus strains (two subtype A strains and one type B strain) – was approved by the Food and Drug Administration in 2015 for adults aged 65 years and older. It was the first influenza vaccine containing the adjuvant MF59 – a purified oil-in-water emulsion of squalene oil added to boost immune response in that population. Its safety was assessed in 15 randomized, controlled clinical studies, and several trials in older adults supported its efficacy and safety over nonadjuvanted influenza vaccines, the investigators reported. They noted that the Advisory Committee on Immunization Practices (ACIP) recommended the vaccine as an option for routine use in adults aged 65 years and older during the 2016-2017 flu seasons.

For the 2018-2019 flu season, ACIP determined that “For persons aged ≥65 years, any age-appropriate IIV formulation (standard-dose or high-dose, trivalent or quadrivalent, unadjuvanted or adjuvanted) or RIV4 are acceptable options.”

The findings of the analysis of the 2017-2018 flu season data are consistent with prelicensure studies, Ms. Haber and her colleagues concluded, noting that data mining did not detect disproportional reporting of any unexpected adverse event.

“[There were] no safety concerns following aIIV3 when compared to the nonadjuvanted influenza vaccines (IIV3-HD or IIV3/IIV4),” they wrote, adding that the “CDC and FDA will continue to monitor and ensure the safety of aIIV3.”

Ms. Haber reported having no disclosures

[email protected]

SOURCE: Haber P et al. ICEID 2018, Board 320.

ATLANTA – Postlicensure surveillance of a trivalent adjuvanted influenza vaccine approved in 2015 for adults aged 65 years and older revealed no new or unexpected patterns of adverse events, according to an analysis of reports to the Vaccine Adverse Event Reporting System (VAERS) during July 2016 through March 2018.

Wavebreakmedia/Thinkstock

VAERS received 630 reports related to the vaccine (aIIV3; FLUAD) during the study period, of which 521 involved adults aged 65 years and older.

“Eighteen (3%) were serious reports, including two death reports (0.4%), all in adults aged [at least] 65 years,” Penina Haber and her colleagues at the Immunization Safety Office at the Centers for Disease Control and Prevention reported in a poster at the International Conference on Emerging Infectious Diseases.

The deaths included a 75-year-old man who died from Sjögren’s syndrome and a 65-year-old man who died from a myocardial infarction. The other serious events included five neurologic disorders (two cases of Guillain-Barré syndrome and one each of Bell’s palsy, Bickerstaff encephalitis, and lower-extremity weakness), five musculoskeletal and connective tissue disorders (three with shoulder pain and two with arm pain), three general disorders and administration site conditions (two cases of fever/chills and one case of cellulitis/bursitis), and one case each of a gastrointestinal disorder (acute diarrhea/gastroenteritis), an injury (a fall), and a skin/subcutaneous tissue disorder (keratosis pilaris rubra), according to the investigators.

There were no reports of anaphylaxis.

For the sake of comparison, the investigators also looked at reports associated with IIV3-HD and IIV3/IIV4 vaccines in adults aged 65 years and older during the same time period; they found that patient characteristics and reported events were similar for all the vaccines. For example, the percentages of reports involving patients aged 65 years and older were 65% or 66% for each, and those involving patients aged 75-84 years were 27%-29%. Further, 0.2%-0.6% of reports for each vaccine involved death.

The most frequently reported events for aIIV3, IIV3-HD, and IIV3/IIV4, respectively, were extremity pain (21%, 17%, and 15%, respectively), injection site erythema (18%, 19%, and 15%), and injection site pain (15%, 16%, and 16%), they said.

The aIIV3 vaccine – the first seasonal inactivated trivalent influenza vaccine produced from three influenza virus strains (two subtype A strains and one type B strain) – was approved by the Food and Drug Administration in 2015 for adults aged 65 years and older. It was the first influenza vaccine containing the adjuvant MF59 – a purified oil-in-water emulsion of squalene oil added to boost immune response in that population. Its safety was assessed in 15 randomized, controlled clinical studies, and several trials in older adults supported its efficacy and safety over nonadjuvanted influenza vaccines, the investigators reported. They noted that the Advisory Committee on Immunization Practices (ACIP) recommended the vaccine as an option for routine use in adults aged 65 years and older during the 2016-2017 flu seasons.

For the 2018-2019 flu season, ACIP determined that “For persons aged ≥65 years, any age-appropriate IIV formulation (standard-dose or high-dose, trivalent or quadrivalent, unadjuvanted or adjuvanted) or RIV4 are acceptable options.”

The findings of the analysis of the 2017-2018 flu season data are consistent with prelicensure studies, Ms. Haber and her colleagues concluded, noting that data mining did not detect disproportional reporting of any unexpected adverse event.

“[There were] no safety concerns following aIIV3 when compared to the nonadjuvanted influenza vaccines (IIV3-HD or IIV3/IIV4),” they wrote, adding that the “CDC and FDA will continue to monitor and ensure the safety of aIIV3.”

Ms. Haber reported having no disclosures

[email protected]

SOURCE: Haber P et al. ICEID 2018, Board 320.

Vitiligo is a disfiguring skin condition that is thought to result from autoimmune destruction of melanocytes in the skin, leading to patchy depigmentation. The prevalence of vitiligo is estimated at 1% worldwide.¹ Once seen as merely a cosmetic disorder, it is increasingly recognized for its devastating psychological effects. As skin quality, texture, and color are a few of the first things people notice about others, skin plays a major role in our daily interactions with the world. Vitiligo often affects the face and other visible areas of the body; thus, it is associated with impaired quality of life, and affected individuals often experience psychosocial impairment including anxiety, depression, stigmatization, and self-harm ideation.² Indeed, vitiligo is a condition with not only a visible skin component but a deeper psychological component that also is important to recognize and address. However, due in large part to recent exposure to vitiligo through mainstream media, general understanding about and attitudes toward this condition are changing. As a result, vitiligo has seen a surge in outreach by those affected by the disease.

Perhaps the most well-known current face of vitiligo is Chantelle Brown-Young, a black fashion model, activist, and vitiligo spokesperson known professionally as Winnie Harlow. Diagnosed with vitiligo in childhood, she revealed she was teased and bullied and at one point contemplated suicide. “The continuous harassment and the despair that [vitiligo] brought on my life was so unbearably dehumanizing that I wanted to kill myself,” she disclosed.³ After competing on America’s Next Top Model in 2014, Winnie Harlow became a household name for redefining global standards of beauty and, in her own words, accepting the differences that make us unique and authentic.⁴ She went on to speak at the Dove Self-Esteem Project panel at the 2015 Women in the World London Summit and was presented with the Role Model award at the Portuguese GQ Men of the Year event that same year.⁵

More recently, Amy Deanna, a model with vitiligo, was featured in videos for CoverGirl’s 2018 “I Am What I Make Up” campaign in which she is shown enhancing her various skin tones rather than hiding them by applying both light and dark shades of makeup on her face. In a press release she stated, “Vitiligo awareness is something that is very important to me. Being given a platform to [raise awareness] means so much.”⁶

Additionally, Brock Elbank, a London-based photographer, recently launched a photograph series of men and women with vitiligo on the digital platform Instagram.⁷ In a recent interview he stated, “I see beauty in what many see as different. Unique individuals who stand out from the crowd are what inspire me to do what I do.”⁷

Lee Thomas, a television broadcaster and author of the book Turning White: A Memoir of Change is yet another example of a vitiligo patient who recently stopped hiding his condition. He admitted he has had people refuse to shake his hand due to his condition but has used the experience to educate others. He stated, “Because I’m in this position, I think this is where my next thing is supposed to be. It’s supposed to be about sharing and helping, and hopefully leaving the planet a little better for everybody else who comes along with vitiligo.”⁸ Thomas is dedicated to inspiring others with the condition and started the Clarity Lee Thomas Foundation to provide emotional and mental support to those with vitiligo.

Critics may say this vitiligo movement is merely another example of exploitation of what is unique or different by mainstream media and the fashion industry, similar to prior movements for plus-sized models, natural hairstyles in black women, and transgender identification. Even if partially true, the ultimate effect has been an increase in attention and representation of individuals with vitiligo in mainstream media. At the time this article was being published (September 2018), an Instagram search for #vitiligo yielded approximately 226,000 posts. For comparison with other much more common dermatologic conditions, #eczema returned approximately 958,000 results, #moles returned approximately 65,000 results, and #skincancer returned approximately 104,000 results. Additionally, the Vitiligo Research Foundation currently has more than 5000 followers on Instagram, which is as many as the Melanoma Research Foundation and almost twice as many as the Skin Cancer Foundation, supporting the idea that mainstream representation of individuals with vitiligo is contributing to raising awareness and backing of organizations aimed at making advancements in this area of dermatology.

As more individuals gain an understanding and curiosity about this disease, perhaps more research and investigation will be done to improve treatment options and outcomes for patients with vitiligo. With this movement, perhaps vitiligo patients will feel more comfortable and confident in their skin.

Vitiligo is a disfiguring skin condition that is thought to result from autoimmune destruction of melanocytes in the skin, leading to patchy depigmentation. The prevalence of vitiligo is estimated at 1% worldwide.¹ Once seen as merely a cosmetic disorder, it is increasingly recognized for its devastating psychological effects. As skin quality, texture, and color are a few of the first things people notice about others, skin plays a major role in our daily interactions with the world. Vitiligo often affects the face and other visible areas of the body; thus, it is associated with impaired quality of life, and affected individuals often experience psychosocial impairment including anxiety, depression, stigmatization, and self-harm ideation.² Indeed, vitiligo is a condition with not only a visible skin component but a deeper psychological component that also is important to recognize and address. However, due in large part to recent exposure to vitiligo through mainstream media, general understanding about and attitudes toward this condition are changing. As a result, vitiligo has seen a surge in outreach by those affected by the disease.

Perhaps the most well-known current face of vitiligo is Chantelle Brown-Young, a black fashion model, activist, and vitiligo spokesperson known professionally as Winnie Harlow. Diagnosed with vitiligo in childhood, she revealed she was teased and bullied and at one point contemplated suicide. “The continuous harassment and the despair that [vitiligo] brought on my life was so unbearably dehumanizing that I wanted to kill myself,” she disclosed.³ After competing on America’s Next Top Model in 2014, Winnie Harlow became a household name for redefining global standards of beauty and, in her own words, accepting the differences that make us unique and authentic.⁴ She went on to speak at the Dove Self-Esteem Project panel at the 2015 Women in the World London Summit and was presented with the Role Model award at the Portuguese GQ Men of the Year event that same year.⁵

More recently, Amy Deanna, a model with vitiligo, was featured in videos for CoverGirl’s 2018 “I Am What I Make Up” campaign in which she is shown enhancing her various skin tones rather than hiding them by applying both light and dark shades of makeup on her face. In a press release she stated, “Vitiligo awareness is something that is very important to me. Being given a platform to [raise awareness] means so much.”⁶

Additionally, Brock Elbank, a London-based photographer, recently launched a photograph series of men and women with vitiligo on the digital platform Instagram.⁷ In a recent interview he stated, “I see beauty in what many see as different. Unique individuals who stand out from the crowd are what inspire me to do what I do.”⁷

Lee Thomas, a television broadcaster and author of the book Turning White: A Memoir of Change is yet another example of a vitiligo patient who recently stopped hiding his condition. He admitted he has had people refuse to shake his hand due to his condition but has used the experience to educate others. He stated, “Because I’m in this position, I think this is where my next thing is supposed to be. It’s supposed to be about sharing and helping, and hopefully leaving the planet a little better for everybody else who comes along with vitiligo.”⁸ Thomas is dedicated to inspiring others with the condition and started the Clarity Lee Thomas Foundation to provide emotional and mental support to those with vitiligo.

Critics may say this vitiligo movement is merely another example of exploitation of what is unique or different by mainstream media and the fashion industry, similar to prior movements for plus-sized models, natural hairstyles in black women, and transgender identification. Even if partially true, the ultimate effect has been an increase in attention and representation of individuals with vitiligo in mainstream media. At the time this article was being published (September 2018), an Instagram search for #vitiligo yielded approximately 226,000 posts. For comparison with other much more common dermatologic conditions, #eczema returned approximately 958,000 results, #moles returned approximately 65,000 results, and #skincancer returned approximately 104,000 results. Additionally, the Vitiligo Research Foundation currently has more than 5000 followers on Instagram, which is as many as the Melanoma Research Foundation and almost twice as many as the Skin Cancer Foundation, supporting the idea that mainstream representation of individuals with vitiligo is contributing to raising awareness and backing of organizations aimed at making advancements in this area of dermatology.

As more individuals gain an understanding and curiosity about this disease, perhaps more research and investigation will be done to improve treatment options and outcomes for patients with vitiligo. With this movement, perhaps vitiligo patients will feel more comfortable and confident in their skin.

Vitiligo is a disfiguring skin condition that is thought to result from autoimmune destruction of melanocytes in the skin, leading to patchy depigmentation. The prevalence of vitiligo is estimated at 1% worldwide.¹ Once seen as merely a cosmetic disorder, it is increasingly recognized for its devastating psychological effects. As skin quality, texture, and color are a few of the first things people notice about others, skin plays a major role in our daily interactions with the world. Vitiligo often affects the face and other visible areas of the body; thus, it is associated with impaired quality of life, and affected individuals often experience psychosocial impairment including anxiety, depression, stigmatization, and self-harm ideation.² Indeed, vitiligo is a condition with not only a visible skin component but a deeper psychological component that also is important to recognize and address. However, due in large part to recent exposure to vitiligo through mainstream media, general understanding about and attitudes toward this condition are changing. As a result, vitiligo has seen a surge in outreach by those affected by the disease.

Perhaps the most well-known current face of vitiligo is Chantelle Brown-Young, a black fashion model, activist, and vitiligo spokesperson known professionally as Winnie Harlow. Diagnosed with vitiligo in childhood, she revealed she was teased and bullied and at one point contemplated suicide. “The continuous harassment and the despair that [vitiligo] brought on my life was so unbearably dehumanizing that I wanted to kill myself,” she disclosed.³ After competing on America’s Next Top Model in 2014, Winnie Harlow became a household name for redefining global standards of beauty and, in her own words, accepting the differences that make us unique and authentic.⁴ She went on to speak at the Dove Self-Esteem Project panel at the 2015 Women in the World London Summit and was presented with the Role Model award at the Portuguese GQ Men of the Year event that same year.⁵

More recently, Amy Deanna, a model with vitiligo, was featured in videos for CoverGirl’s 2018 “I Am What I Make Up” campaign in which she is shown enhancing her various skin tones rather than hiding them by applying both light and dark shades of makeup on her face. In a press release she stated, “Vitiligo awareness is something that is very important to me. Being given a platform to [raise awareness] means so much.”⁶

Additionally, Brock Elbank, a London-based photographer, recently launched a photograph series of men and women with vitiligo on the digital platform Instagram.⁷ In a recent interview he stated, “I see beauty in what many see as different. Unique individuals who stand out from the crowd are what inspire me to do what I do.”⁷

Lee Thomas, a television broadcaster and author of the book Turning White: A Memoir of Change is yet another example of a vitiligo patient who recently stopped hiding his condition. He admitted he has had people refuse to shake his hand due to his condition but has used the experience to educate others. He stated, “Because I’m in this position, I think this is where my next thing is supposed to be. It’s supposed to be about sharing and helping, and hopefully leaving the planet a little better for everybody else who comes along with vitiligo.”⁸ Thomas is dedicated to inspiring others with the condition and started the Clarity Lee Thomas Foundation to provide emotional and mental support to those with vitiligo.

Critics may say this vitiligo movement is merely another example of exploitation of what is unique or different by mainstream media and the fashion industry, similar to prior movements for plus-sized models, natural hairstyles in black women, and transgender identification. Even if partially true, the ultimate effect has been an increase in attention and representation of individuals with vitiligo in mainstream media. At the time this article was being published (September 2018), an Instagram search for #vitiligo yielded approximately 226,000 posts. For comparison with other much more common dermatologic conditions, #eczema returned approximately 958,000 results, #moles returned approximately 65,000 results, and #skincancer returned approximately 104,000 results. Additionally, the Vitiligo Research Foundation currently has more than 5000 followers on Instagram, which is as many as the Melanoma Research Foundation and almost twice as many as the Skin Cancer Foundation, supporting the idea that mainstream representation of individuals with vitiligo is contributing to raising awareness and backing of organizations aimed at making advancements in this area of dermatology.

As more individuals gain an understanding and curiosity about this disease, perhaps more research and investigation will be done to improve treatment options and outcomes for patients with vitiligo. With this movement, perhaps vitiligo patients will feel more comfortable and confident in their skin.

The American College of Obstetricians and Gynecologists offered its backing for a bill that would lend federal support to existing and new maternal mortality review committees.

Courtesy House Energy & Commerce Committee

The Preventing Maternal Deaths Act of 2018 (H.R. 1318) was the subject of a Sept. 27 hearing of the House Energy and Commerce Health Subcommittee. The bill comes at a time when 700 women a year die as a result of pregnancy or pregnancy-related complications with a rate that is increasing, while 157 of 183 countries around the world are reporting decreasing rates of maternal mortality, according to ACOG.

The bill, authored by Rep. Jamie Herrera Beutler (R-Wash.) and Diana DeGette (D-Colo.) would allocate $58 million for each fiscal year from 2019 through 2023 to support the 33 existing states with maternal mortality review committees (MMRCs) and help the remaining 17 states develop them, as well as to standardize data collection across the nation.

The goal of having these committees in place is to “improve data collection and reporting around maternal mortality, and to develop or support surveillance systems at the local, state, and national level in order to better understand the burden of maternal complications,” a background memo on the hearing noted. “These surveillance efforts include identifying groups of women with disproportionately high rates of maternal mortality and identifying the determinants of disparities in maternal care, health risks, and health outcomes.”

Necessitating this legislation was a data point that was reiterated throughout the course of the hearing – that maternal mortality rates in the United States were on the rise.

“What’s both surprising and devastating is that, despite massive innovation and advances in health care and technology, we’ve experienced recent reports that have indicated that the number of women dying due to pregnancy complications is actually increasing,” Full Committee Chairman Greg Walden (R-Ore.) said in his opening remarks at the hearing. “According to the Centers for Disease Control and Prevention, maternal mortality rates in America have more than doubled since 1987. I think we are asking, how can that be? This is not a statistic any of us wants to hear.”

Chairman Walden acknowledged that there are questions as to whether the increase was a function of better data collection or whether it was an issue with the delivery of health care.

“The bill before us today will help us answer these really important questions and hopefully ensure that expectant newborn mothers receive even better care,” he said.

Lynne M. Coslett-Charlton, MD, ACOG Pennsylvania District legislative chair, offered the organization’s support for the bill.

MMRCs “are multidisciplinary groups of local experts in maternal and public health, as well as patient and community advocates, that closely examine maternal death cases and identify locally relevant ways to prevent future deaths,” she testified before the committee. “While traditional public health surveillance using vital statistics can tell us about trends and disparities, MMRCs are best positioned to comprehensively assess maternal deaths and identify opportunities for prevention.”

Dr. Coslett-Charlton added that to clearly understand why women are dying from preventable maternal complications, which she noted that 60% of maternal deaths are, “every state must have a robust MMRC. The Preventing Maternal Deaths Act will help us reach that goal, and ultimately improve maternal health across this nation,” as these committees review every maternal death and can make a determination as to whether they could have been preventable.

Additionally, the fact that black women face a significantly higher rate of maternal mortality was another data point highlighted during the hearing, further adding to the need for this bill that has bipartisan support and more than 170 cosponsors.

Rep. DeGette called it “one of the most striking aspects” that black women “are nearly four times as likely to experience a pregnancy-related death.”

Stacey D. Stewart, president of the March of Dimes, in her written testimony praised the inclusion in H.R. 1318 of a “demonstration project to determine how best to address disparities in maternal health outcomes.”

[email protected]

The American College of Obstetricians and Gynecologists offered its backing for a bill that would lend federal support to existing and new maternal mortality review committees.

Courtesy House Energy & Commerce Committee

The Preventing Maternal Deaths Act of 2018 (H.R. 1318) was the subject of a Sept. 27 hearing of the House Energy and Commerce Health Subcommittee. The bill comes at a time when 700 women a year die as a result of pregnancy or pregnancy-related complications with a rate that is increasing, while 157 of 183 countries around the world are reporting decreasing rates of maternal mortality, according to ACOG.

The bill, authored by Rep. Jamie Herrera Beutler (R-Wash.) and Diana DeGette (D-Colo.) would allocate $58 million for each fiscal year from 2019 through 2023 to support the 33 existing states with maternal mortality review committees (MMRCs) and help the remaining 17 states develop them, as well as to standardize data collection across the nation.

The goal of having these committees in place is to “improve data collection and reporting around maternal mortality, and to develop or support surveillance systems at the local, state, and national level in order to better understand the burden of maternal complications,” a background memo on the hearing noted. “These surveillance efforts include identifying groups of women with disproportionately high rates of maternal mortality and identifying the determinants of disparities in maternal care, health risks, and health outcomes.”

Necessitating this legislation was a data point that was reiterated throughout the course of the hearing – that maternal mortality rates in the United States were on the rise.

“What’s both surprising and devastating is that, despite massive innovation and advances in health care and technology, we’ve experienced recent reports that have indicated that the number of women dying due to pregnancy complications is actually increasing,” Full Committee Chairman Greg Walden (R-Ore.) said in his opening remarks at the hearing. “According to the Centers for Disease Control and Prevention, maternal mortality rates in America have more than doubled since 1987. I think we are asking, how can that be? This is not a statistic any of us wants to hear.”

Chairman Walden acknowledged that there are questions as to whether the increase was a function of better data collection or whether it was an issue with the delivery of health care.

“The bill before us today will help us answer these really important questions and hopefully ensure that expectant newborn mothers receive even better care,” he said.

Lynne M. Coslett-Charlton, MD, ACOG Pennsylvania District legislative chair, offered the organization’s support for the bill.

MMRCs “are multidisciplinary groups of local experts in maternal and public health, as well as patient and community advocates, that closely examine maternal death cases and identify locally relevant ways to prevent future deaths,” she testified before the committee. “While traditional public health surveillance using vital statistics can tell us about trends and disparities, MMRCs are best positioned to comprehensively assess maternal deaths and identify opportunities for prevention.”

Dr. Coslett-Charlton added that to clearly understand why women are dying from preventable maternal complications, which she noted that 60% of maternal deaths are, “every state must have a robust MMRC. The Preventing Maternal Deaths Act will help us reach that goal, and ultimately improve maternal health across this nation,” as these committees review every maternal death and can make a determination as to whether they could have been preventable.

Additionally, the fact that black women face a significantly higher rate of maternal mortality was another data point highlighted during the hearing, further adding to the need for this bill that has bipartisan support and more than 170 cosponsors.

Rep. DeGette called it “one of the most striking aspects” that black women “are nearly four times as likely to experience a pregnancy-related death.”

Stacey D. Stewart, president of the March of Dimes, in her written testimony praised the inclusion in H.R. 1318 of a “demonstration project to determine how best to address disparities in maternal health outcomes.”

[email protected]

The American College of Obstetricians and Gynecologists offered its backing for a bill that would lend federal support to existing and new maternal mortality review committees.

Courtesy House Energy & Commerce Committee

The Preventing Maternal Deaths Act of 2018 (H.R. 1318) was the subject of a Sept. 27 hearing of the House Energy and Commerce Health Subcommittee. The bill comes at a time when 700 women a year die as a result of pregnancy or pregnancy-related complications with a rate that is increasing, while 157 of 183 countries around the world are reporting decreasing rates of maternal mortality, according to ACOG.

The bill, authored by Rep. Jamie Herrera Beutler (R-Wash.) and Diana DeGette (D-Colo.) would allocate $58 million for each fiscal year from 2019 through 2023 to support the 33 existing states with maternal mortality review committees (MMRCs) and help the remaining 17 states develop them, as well as to standardize data collection across the nation.

The goal of having these committees in place is to “improve data collection and reporting around maternal mortality, and to develop or support surveillance systems at the local, state, and national level in order to better understand the burden of maternal complications,” a background memo on the hearing noted. “These surveillance efforts include identifying groups of women with disproportionately high rates of maternal mortality and identifying the determinants of disparities in maternal care, health risks, and health outcomes.”

Necessitating this legislation was a data point that was reiterated throughout the course of the hearing – that maternal mortality rates in the United States were on the rise.

“What’s both surprising and devastating is that, despite massive innovation and advances in health care and technology, we’ve experienced recent reports that have indicated that the number of women dying due to pregnancy complications is actually increasing,” Full Committee Chairman Greg Walden (R-Ore.) said in his opening remarks at the hearing. “According to the Centers for Disease Control and Prevention, maternal mortality rates in America have more than doubled since 1987. I think we are asking, how can that be? This is not a statistic any of us wants to hear.”

Chairman Walden acknowledged that there are questions as to whether the increase was a function of better data collection or whether it was an issue with the delivery of health care.

“The bill before us today will help us answer these really important questions and hopefully ensure that expectant newborn mothers receive even better care,” he said.

Lynne M. Coslett-Charlton, MD, ACOG Pennsylvania District legislative chair, offered the organization’s support for the bill.

MMRCs “are multidisciplinary groups of local experts in maternal and public health, as well as patient and community advocates, that closely examine maternal death cases and identify locally relevant ways to prevent future deaths,” she testified before the committee. “While traditional public health surveillance using vital statistics can tell us about trends and disparities, MMRCs are best positioned to comprehensively assess maternal deaths and identify opportunities for prevention.”

Dr. Coslett-Charlton added that to clearly understand why women are dying from preventable maternal complications, which she noted that 60% of maternal deaths are, “every state must have a robust MMRC. The Preventing Maternal Deaths Act will help us reach that goal, and ultimately improve maternal health across this nation,” as these committees review every maternal death and can make a determination as to whether they could have been preventable.

Additionally, the fact that black women face a significantly higher rate of maternal mortality was another data point highlighted during the hearing, further adding to the need for this bill that has bipartisan support and more than 170 cosponsors.

Rep. DeGette called it “one of the most striking aspects” that black women “are nearly four times as likely to experience a pregnancy-related death.”

Stacey D. Stewart, president of the March of Dimes, in her written testimony praised the inclusion in H.R. 1318 of a “demonstration project to determine how best to address disparities in maternal health outcomes.”

[email protected]

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Prices that hospitals pay for cardiac implant devices are two to six times higher in the United States than in Europe, according to analysis of a large hospital panel survey.

U.S. hospitals had an estimated mean cost of $670 for a bare-metal stent in 2014, compared with $120 in Germany, and the mean costs for dual-chamber pacemakers that year were $4,200 in the United States and $1,400 in Germany, which had lower costs for cardiac devices than the other three European countries – United Kingdom, France, and Italy – included in the study, Martin Wenzl, MSc, and Elias Mossialos, MD, PhD, reported in Health Affairs.

France generally had the highest costs among the European countries, with Italy next and then the United Kingdom. The estimated cost of bare-metal stents was actually higher for French hospitals ($750) than for those in the United States, and Italy had mean prices similar to the United Sates for dual-chamber implantable cardioverter-defibrillators. The prices of implantable cardioverter-defibrillators and cardiac resynchronization devices with defibrillating function were the other exceptions, with the United Kingdom similar to or higher than the United States, said Mr. Wenzl and Dr. Mossialos, both of the London School of Economics and Political Science.

The analysis of data from Decision Resources Group’s Marketrack hospital surveys also showed significant variation between the hospitals in each country, with the exception of France, where payments are based on the specific device rather than the procedure and the system “creates weak incentives for hospitals to negotiate lower prices,” they said. In most of the device categories, “variation between hospitals in each country was similar to variation between countries,” they wrote, adding that prices in general “were only weakly correlated with volumes purchased by hospitals.”

The study was supported by a grant from the Commonwealth Fund. The investigators did not disclose any possible conflicts of interest.

[email protected]

SOURCE: Wenzi M, Mossialos E. Health Aff. 2018;37[10]:1570-77. doi: 10.1377/hlthaff.2017.1367.

Prices that hospitals pay for cardiac implant devices are two to six times higher in the United States than in Europe, according to analysis of a large hospital panel survey.

U.S. hospitals had an estimated mean cost of $670 for a bare-metal stent in 2014, compared with $120 in Germany, and the mean costs for dual-chamber pacemakers that year were $4,200 in the United States and $1,400 in Germany, which had lower costs for cardiac devices than the other three European countries – United Kingdom, France, and Italy – included in the study, Martin Wenzl, MSc, and Elias Mossialos, MD, PhD, reported in Health Affairs.

France generally had the highest costs among the European countries, with Italy next and then the United Kingdom. The estimated cost of bare-metal stents was actually higher for French hospitals ($750) than for those in the United States, and Italy had mean prices similar to the United Sates for dual-chamber implantable cardioverter-defibrillators. The prices of implantable cardioverter-defibrillators and cardiac resynchronization devices with defibrillating function were the other exceptions, with the United Kingdom similar to or higher than the United States, said Mr. Wenzl and Dr. Mossialos, both of the London School of Economics and Political Science.

The analysis of data from Decision Resources Group’s Marketrack hospital surveys also showed significant variation between the hospitals in each country, with the exception of France, where payments are based on the specific device rather than the procedure and the system “creates weak incentives for hospitals to negotiate lower prices,” they said. In most of the device categories, “variation between hospitals in each country was similar to variation between countries,” they wrote, adding that prices in general “were only weakly correlated with volumes purchased by hospitals.”

The study was supported by a grant from the Commonwealth Fund. The investigators did not disclose any possible conflicts of interest.

[email protected]

SOURCE: Wenzi M, Mossialos E. Health Aff. 2018;37[10]:1570-77. doi: 10.1377/hlthaff.2017.1367.

Prices that hospitals pay for cardiac implant devices are two to six times higher in the United States than in Europe, according to analysis of a large hospital panel survey.

U.S. hospitals had an estimated mean cost of $670 for a bare-metal stent in 2014, compared with $120 in Germany, and the mean costs for dual-chamber pacemakers that year were $4,200 in the United States and $1,400 in Germany, which had lower costs for cardiac devices than the other three European countries – United Kingdom, France, and Italy – included in the study, Martin Wenzl, MSc, and Elias Mossialos, MD, PhD, reported in Health Affairs.

France generally had the highest costs among the European countries, with Italy next and then the United Kingdom. The estimated cost of bare-metal stents was actually higher for French hospitals ($750) than for those in the United States, and Italy had mean prices similar to the United Sates for dual-chamber implantable cardioverter-defibrillators. The prices of implantable cardioverter-defibrillators and cardiac resynchronization devices with defibrillating function were the other exceptions, with the United Kingdom similar to or higher than the United States, said Mr. Wenzl and Dr. Mossialos, both of the London School of Economics and Political Science.

The analysis of data from Decision Resources Group’s Marketrack hospital surveys also showed significant variation between the hospitals in each country, with the exception of France, where payments are based on the specific device rather than the procedure and the system “creates weak incentives for hospitals to negotiate lower prices,” they said. In most of the device categories, “variation between hospitals in each country was similar to variation between countries,” they wrote, adding that prices in general “were only weakly correlated with volumes purchased by hospitals.”

The study was supported by a grant from the Commonwealth Fund. The investigators did not disclose any possible conflicts of interest.

[email protected]

SOURCE: Wenzi M, Mossialos E. Health Aff. 2018;37[10]:1570-77. doi: 10.1377/hlthaff.2017.1367.

ATLANTA – The 13-valent pneumococcal conjugate vaccine (PCV13) shows moderate overall effectiveness for preventing invasive pneumococcal disease (IPD) caused by PCV13 vaccine serotypes in adults aged 65 years and older, according to a case-control study involving Medicare beneficiaries.

Sharon Worcester/MDedge News

Conversely, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) showed limited effectiveness against serotypes unique to that vaccine in the study, which included 699 cases and more than 10,000 controls, Olivia Almendares, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.

“Vaccine efficacy against PCV13 [plus 6C type, which has cross-reactivity with serotype 6A] was 47% in those who received PCV13 vaccine only,” Ms. Almendares said in an interview, noting that efficacy was 26% against serotype 3 and 67% against other PCV13 serotypes (plus 6C). “Vaccine efficacy against PPSV23-unique types was 36% for those who received only PPSV23.”

Neither vaccine showed effectiveness against serotypes not included in the respective vaccines, she said.

The findings are timely given that the Advisory Committee on Immunization Practices (ACIP) is reevaluating its PCV13 recommendation for adults aged 65 years and older, she added.

“Specifically, ACIP is addressing whether PCV13 should be recommended routinely for all immunocompetent adults aged 65 and older given sustained indirect effects,” she said, explaining that, in 2014 when ACIP recommended routine use of the vaccine in series with PPSV23 for adults aged 65 years and older, the committee recognized that herd immunity effects from PCV13 use in children might eventually limit the utility of this recommendation, and therefore it proposed reevaluation and revision as needed after 4 years.

For the current study, she and her colleagues linked IPD cases in persons aged 65 years and older, which were identified through Active Bacterial Core surveillance during 2015-2016, to records for Centers for Medicare & Medicaid Services (CMS) beneficiaries. Vaccination and medical histories were obtained through medical records, and vaccine effectiveness was estimated as one minus the odds ratio for vaccination with PCV13 only or PPSV23 only versus neither vaccine using conditional logistic regression, with adjustment for sex and underlying medical conditions.

Of 2,246 IPD cases, 1,017 (45%) were matched to Medicare beneficiaries, and 699 were included in the analysis after those with noncontinuous enrollment in Medicare, long-term care residence, and missing census tract data were excluded. The cases were matched based on age, census tract of residence, and length of Medicare enrollment to 10,152 matched controls identified through CMS.

IPD associated with PCV13 (plus type 6C) accounted for 164 (23% of cases), of which 88 (12% of cases) involved serotype 3, and invasive pneumococcal disease associated with PPSV23 accounted for 350 cases (50%), she said.

PCV13 vaccine was given alone in 14% and 18% of cases and controls, respectively; PPSV23 alone was given in 22% and 21% of case patients and controls, respectively; and both vaccines were given in 8% of cases and controls.

Compared with controls, case patients were more likely to be of nonwhite race (16% vs. 11%), to have more than one chronic medical condition (88% vs. 58%), and to have one or more immunocompromising conditions (54% vs. 32%), she and her colleagues reported.

“PCV13 showed moderate overall effectiveness in preventing IPD caused by PCV13 (including 6C), but effectiveness may be lower for serotype 3 than for other PCV13 types,” she said.

“These results are in agreement with those from CAPiTA – a large clinical trial conducted in the Netherlands, which showed PCV13 to be effective against IPD caused by vaccine serotypes among community-dwelling adults aged 65 and older,” she noted. “Additionally, data from CDC surveillance suggest that PCV13-serotype [invasive pneumococcal disease] among children and adults aged 65 and older has declined dramatically following PCV13 introduction for children in 2010, as predicted.”

In fact, among adults aged 65 years and older, PCV13-serotype invasive pneumococcal disease declined by 40% after the vaccine was introduced in children. This corresponds to a change in the annual PCV13-serotype incidence from 14 cases per 100,000 population in 2010 to five cases per 100,000 population in 2014, she said; she added that IPD incidence plateaued in 2014-2016 with vaccine serotypes contributing to a small proportion of overall IPD burden among adults aged 65 years and older.

ACIP’s reevaluation of the PCV13 recommendation is ongoing and will be addressed at upcoming meetings.

“As part of the review process, we look at changes in disease incidence focusing primarily on invasive pneumococcal disease and noninvasive pneumonia, vaccine efficacy and effectiveness, and vaccine safety,” she said. She noted that ACIP currently has no plans to consider revising PCV13 recommendations for adults who have immunocompromising conditions, for whom PCV13 has been recommended since 2012.

Ms. Almendares reported having no disclosures.

[email protected]

SOURCE: Almendares O et al. ICEID 2018, Board 376.

ATLANTA – The 13-valent pneumococcal conjugate vaccine (PCV13) shows moderate overall effectiveness for preventing invasive pneumococcal disease (IPD) caused by PCV13 vaccine serotypes in adults aged 65 years and older, according to a case-control study involving Medicare beneficiaries.

Sharon Worcester/MDedge News

Conversely, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) showed limited effectiveness against serotypes unique to that vaccine in the study, which included 699 cases and more than 10,000 controls, Olivia Almendares, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.

“Vaccine efficacy against PCV13 [plus 6C type, which has cross-reactivity with serotype 6A] was 47% in those who received PCV13 vaccine only,” Ms. Almendares said in an interview, noting that efficacy was 26% against serotype 3 and 67% against other PCV13 serotypes (plus 6C). “Vaccine efficacy against PPSV23-unique types was 36% for those who received only PPSV23.”

Neither vaccine showed effectiveness against serotypes not included in the respective vaccines, she said.

The findings are timely given that the Advisory Committee on Immunization Practices (ACIP) is reevaluating its PCV13 recommendation for adults aged 65 years and older, she added.

“Specifically, ACIP is addressing whether PCV13 should be recommended routinely for all immunocompetent adults aged 65 and older given sustained indirect effects,” she said, explaining that, in 2014 when ACIP recommended routine use of the vaccine in series with PPSV23 for adults aged 65 years and older, the committee recognized that herd immunity effects from PCV13 use in children might eventually limit the utility of this recommendation, and therefore it proposed reevaluation and revision as needed after 4 years.

For the current study, she and her colleagues linked IPD cases in persons aged 65 years and older, which were identified through Active Bacterial Core surveillance during 2015-2016, to records for Centers for Medicare & Medicaid Services (CMS) beneficiaries. Vaccination and medical histories were obtained through medical records, and vaccine effectiveness was estimated as one minus the odds ratio for vaccination with PCV13 only or PPSV23 only versus neither vaccine using conditional logistic regression, with adjustment for sex and underlying medical conditions.

Of 2,246 IPD cases, 1,017 (45%) were matched to Medicare beneficiaries, and 699 were included in the analysis after those with noncontinuous enrollment in Medicare, long-term care residence, and missing census tract data were excluded. The cases were matched based on age, census tract of residence, and length of Medicare enrollment to 10,152 matched controls identified through CMS.

IPD associated with PCV13 (plus type 6C) accounted for 164 (23% of cases), of which 88 (12% of cases) involved serotype 3, and invasive pneumococcal disease associated with PPSV23 accounted for 350 cases (50%), she said.

PCV13 vaccine was given alone in 14% and 18% of cases and controls, respectively; PPSV23 alone was given in 22% and 21% of case patients and controls, respectively; and both vaccines were given in 8% of cases and controls.

Compared with controls, case patients were more likely to be of nonwhite race (16% vs. 11%), to have more than one chronic medical condition (88% vs. 58%), and to have one or more immunocompromising conditions (54% vs. 32%), she and her colleagues reported.

“PCV13 showed moderate overall effectiveness in preventing IPD caused by PCV13 (including 6C), but effectiveness may be lower for serotype 3 than for other PCV13 types,” she said.

“These results are in agreement with those from CAPiTA – a large clinical trial conducted in the Netherlands, which showed PCV13 to be effective against IPD caused by vaccine serotypes among community-dwelling adults aged 65 and older,” she noted. “Additionally, data from CDC surveillance suggest that PCV13-serotype [invasive pneumococcal disease] among children and adults aged 65 and older has declined dramatically following PCV13 introduction for children in 2010, as predicted.”

In fact, among adults aged 65 years and older, PCV13-serotype invasive pneumococcal disease declined by 40% after the vaccine was introduced in children. This corresponds to a change in the annual PCV13-serotype incidence from 14 cases per 100,000 population in 2010 to five cases per 100,000 population in 2014, she said; she added that IPD incidence plateaued in 2014-2016 with vaccine serotypes contributing to a small proportion of overall IPD burden among adults aged 65 years and older.

ACIP’s reevaluation of the PCV13 recommendation is ongoing and will be addressed at upcoming meetings.

“As part of the review process, we look at changes in disease incidence focusing primarily on invasive pneumococcal disease and noninvasive pneumonia, vaccine efficacy and effectiveness, and vaccine safety,” she said. She noted that ACIP currently has no plans to consider revising PCV13 recommendations for adults who have immunocompromising conditions, for whom PCV13 has been recommended since 2012.

Ms. Almendares reported having no disclosures.

[email protected]

SOURCE: Almendares O et al. ICEID 2018, Board 376.

ATLANTA – The 13-valent pneumococcal conjugate vaccine (PCV13) shows moderate overall effectiveness for preventing invasive pneumococcal disease (IPD) caused by PCV13 vaccine serotypes in adults aged 65 years and older, according to a case-control study involving Medicare beneficiaries.

Sharon Worcester/MDedge News

Conversely, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) showed limited effectiveness against serotypes unique to that vaccine in the study, which included 699 cases and more than 10,000 controls, Olivia Almendares, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.

“Vaccine efficacy against PCV13 [plus 6C type, which has cross-reactivity with serotype 6A] was 47% in those who received PCV13 vaccine only,” Ms. Almendares said in an interview, noting that efficacy was 26% against serotype 3 and 67% against other PCV13 serotypes (plus 6C). “Vaccine efficacy against PPSV23-unique types was 36% for those who received only PPSV23.”

Neither vaccine showed effectiveness against serotypes not included in the respective vaccines, she said.

The findings are timely given that the Advisory Committee on Immunization Practices (ACIP) is reevaluating its PCV13 recommendation for adults aged 65 years and older, she added.

“Specifically, ACIP is addressing whether PCV13 should be recommended routinely for all immunocompetent adults aged 65 and older given sustained indirect effects,” she said, explaining that, in 2014 when ACIP recommended routine use of the vaccine in series with PPSV23 for adults aged 65 years and older, the committee recognized that herd immunity effects from PCV13 use in children might eventually limit the utility of this recommendation, and therefore it proposed reevaluation and revision as needed after 4 years.

For the current study, she and her colleagues linked IPD cases in persons aged 65 years and older, which were identified through Active Bacterial Core surveillance during 2015-2016, to records for Centers for Medicare & Medicaid Services (CMS) beneficiaries. Vaccination and medical histories were obtained through medical records, and vaccine effectiveness was estimated as one minus the odds ratio for vaccination with PCV13 only or PPSV23 only versus neither vaccine using conditional logistic regression, with adjustment for sex and underlying medical conditions.

Of 2,246 IPD cases, 1,017 (45%) were matched to Medicare beneficiaries, and 699 were included in the analysis after those with noncontinuous enrollment in Medicare, long-term care residence, and missing census tract data were excluded. The cases were matched based on age, census tract of residence, and length of Medicare enrollment to 10,152 matched controls identified through CMS.

IPD associated with PCV13 (plus type 6C) accounted for 164 (23% of cases), of which 88 (12% of cases) involved serotype 3, and invasive pneumococcal disease associated with PPSV23 accounted for 350 cases (50%), she said.

PCV13 vaccine was given alone in 14% and 18% of cases and controls, respectively; PPSV23 alone was given in 22% and 21% of case patients and controls, respectively; and both vaccines were given in 8% of cases and controls.

Compared with controls, case patients were more likely to be of nonwhite race (16% vs. 11%), to have more than one chronic medical condition (88% vs. 58%), and to have one or more immunocompromising conditions (54% vs. 32%), she and her colleagues reported.

“PCV13 showed moderate overall effectiveness in preventing IPD caused by PCV13 (including 6C), but effectiveness may be lower for serotype 3 than for other PCV13 types,” she said.

“These results are in agreement with those from CAPiTA – a large clinical trial conducted in the Netherlands, which showed PCV13 to be effective against IPD caused by vaccine serotypes among community-dwelling adults aged 65 and older,” she noted. “Additionally, data from CDC surveillance suggest that PCV13-serotype [invasive pneumococcal disease] among children and adults aged 65 and older has declined dramatically following PCV13 introduction for children in 2010, as predicted.”

In fact, among adults aged 65 years and older, PCV13-serotype invasive pneumococcal disease declined by 40% after the vaccine was introduced in children. This corresponds to a change in the annual PCV13-serotype incidence from 14 cases per 100,000 population in 2010 to five cases per 100,000 population in 2014, she said; she added that IPD incidence plateaued in 2014-2016 with vaccine serotypes contributing to a small proportion of overall IPD burden among adults aged 65 years and older.

ACIP’s reevaluation of the PCV13 recommendation is ongoing and will be addressed at upcoming meetings.

“As part of the review process, we look at changes in disease incidence focusing primarily on invasive pneumococcal disease and noninvasive pneumonia, vaccine efficacy and effectiveness, and vaccine safety,” she said. She noted that ACIP currently has no plans to consider revising PCV13 recommendations for adults who have immunocompromising conditions, for whom PCV13 has been recommended since 2012.

Ms. Almendares reported having no disclosures.

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SOURCE: Almendares O et al. ICEID 2018, Board 376.