Geriatrics

Bariatric surgery may yield increases in muscle mass from baseline among older adults, findings from a small study suggest.

Although bariatric surgery can be used to treat obesity and related comorbidities in older adults, “here are concerns of excess loss of muscle mass after bariatric surgery, especially in elderly patients whose muscle tends to be less, compared to younger patients, at baseline,” wrote Moiz Dawood, MD, of Banner Gateway Medical Center, Gilbert, Ariz., and colleagues.

In a study presented in a poster at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education, the researchers reviewed data from 89 adults older than 65 years (74% women) who underwent either laparoscopic sleeve gastrectomy (87 patients) or Roux-en-Y gastric bypass (2 patients) between May 2015 and March 2017.

At baseline, the average total body weight was 251 pounds and the average muscle mass percent was 50%. At 12 months after surgery, the average weight of the patients decreased to 197 pounds and the percentage of muscle mass increased to 55% (P < .001 for both).

The study findings were limited by the small sample size and retrospective design. However, the results support the benefits of bariatric surgery for older adults, not only with reductions in total body weight loss, but also increasing the total percentage of muscle mass, the researchers said.

The study is important in light of the ongoing discussion regarding the age limit for bariatric surgery, Dr. Dawood said in an interview. “Currently there is no upper age cutoff for patients who undergo bariatric surgery, and understanding the relationship between muscle mass and bariatric surgery would help in determining if there was a negative relationship,” he said.

“The results definitely point toward evidence that suggests that elderly patients do not lose muscle mass to a significant degree,” Dr. Dawood noted. “Muscle mass definitions and calculations also include variables such as weight and fat content. With the additional loss in weight after surgery, it was expected that the muscle mass composition would be affected,” he explained. “However, the results clearly show that even up to 1 year after surgery, older patients who lose weight do not lose significant weight from their muscle mass,” he noted.

The take-home message for clinicians, said Dr. Dawood, is “to understand that metabolic and bariatric surgery, when performed cohesively in a unified program that focuses on lifestyle and dietary changes, is the best way to achieve sustained weight loss.” He added, “this study indicates that physiologic changes that occur after weight loss surgery are not detrimental in the elderly population.”

Next steps for research include further studies in the elderly population to examine the physiologic changes that occur after weight loss surgery, said Dr. Dawood. “Being able to characterize the metabolic changes will help in answering the question of whether there is an upper age cut-off for patients undergoing bariatric surgery.”

Global Academy for Medical Education and this news organization are owned by the same parent company. The researchers had no relevant financial conflicts to disclose.

Bariatric surgery may yield increases in muscle mass from baseline among older adults, findings from a small study suggest.

Although bariatric surgery can be used to treat obesity and related comorbidities in older adults, “here are concerns of excess loss of muscle mass after bariatric surgery, especially in elderly patients whose muscle tends to be less, compared to younger patients, at baseline,” wrote Moiz Dawood, MD, of Banner Gateway Medical Center, Gilbert, Ariz., and colleagues.

In a study presented in a poster at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education, the researchers reviewed data from 89 adults older than 65 years (74% women) who underwent either laparoscopic sleeve gastrectomy (87 patients) or Roux-en-Y gastric bypass (2 patients) between May 2015 and March 2017.

At baseline, the average total body weight was 251 pounds and the average muscle mass percent was 50%. At 12 months after surgery, the average weight of the patients decreased to 197 pounds and the percentage of muscle mass increased to 55% (P < .001 for both).

The study findings were limited by the small sample size and retrospective design. However, the results support the benefits of bariatric surgery for older adults, not only with reductions in total body weight loss, but also increasing the total percentage of muscle mass, the researchers said.

The study is important in light of the ongoing discussion regarding the age limit for bariatric surgery, Dr. Dawood said in an interview. “Currently there is no upper age cutoff for patients who undergo bariatric surgery, and understanding the relationship between muscle mass and bariatric surgery would help in determining if there was a negative relationship,” he said.

“The results definitely point toward evidence that suggests that elderly patients do not lose muscle mass to a significant degree,” Dr. Dawood noted. “Muscle mass definitions and calculations also include variables such as weight and fat content. With the additional loss in weight after surgery, it was expected that the muscle mass composition would be affected,” he explained. “However, the results clearly show that even up to 1 year after surgery, older patients who lose weight do not lose significant weight from their muscle mass,” he noted.

The take-home message for clinicians, said Dr. Dawood, is “to understand that metabolic and bariatric surgery, when performed cohesively in a unified program that focuses on lifestyle and dietary changes, is the best way to achieve sustained weight loss.” He added, “this study indicates that physiologic changes that occur after weight loss surgery are not detrimental in the elderly population.”

Next steps for research include further studies in the elderly population to examine the physiologic changes that occur after weight loss surgery, said Dr. Dawood. “Being able to characterize the metabolic changes will help in answering the question of whether there is an upper age cut-off for patients undergoing bariatric surgery.”

Global Academy for Medical Education and this news organization are owned by the same parent company. The researchers had no relevant financial conflicts to disclose.

Bariatric surgery may yield increases in muscle mass from baseline among older adults, findings from a small study suggest.

Although bariatric surgery can be used to treat obesity and related comorbidities in older adults, “here are concerns of excess loss of muscle mass after bariatric surgery, especially in elderly patients whose muscle tends to be less, compared to younger patients, at baseline,” wrote Moiz Dawood, MD, of Banner Gateway Medical Center, Gilbert, Ariz., and colleagues.

In a study presented in a poster at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education, the researchers reviewed data from 89 adults older than 65 years (74% women) who underwent either laparoscopic sleeve gastrectomy (87 patients) or Roux-en-Y gastric bypass (2 patients) between May 2015 and March 2017.

At baseline, the average total body weight was 251 pounds and the average muscle mass percent was 50%. At 12 months after surgery, the average weight of the patients decreased to 197 pounds and the percentage of muscle mass increased to 55% (P < .001 for both).

The study findings were limited by the small sample size and retrospective design. However, the results support the benefits of bariatric surgery for older adults, not only with reductions in total body weight loss, but also increasing the total percentage of muscle mass, the researchers said.

The study is important in light of the ongoing discussion regarding the age limit for bariatric surgery, Dr. Dawood said in an interview. “Currently there is no upper age cutoff for patients who undergo bariatric surgery, and understanding the relationship between muscle mass and bariatric surgery would help in determining if there was a negative relationship,” he said.

“The results definitely point toward evidence that suggests that elderly patients do not lose muscle mass to a significant degree,” Dr. Dawood noted. “Muscle mass definitions and calculations also include variables such as weight and fat content. With the additional loss in weight after surgery, it was expected that the muscle mass composition would be affected,” he explained. “However, the results clearly show that even up to 1 year after surgery, older patients who lose weight do not lose significant weight from their muscle mass,” he noted.

The take-home message for clinicians, said Dr. Dawood, is “to understand that metabolic and bariatric surgery, when performed cohesively in a unified program that focuses on lifestyle and dietary changes, is the best way to achieve sustained weight loss.” He added, “this study indicates that physiologic changes that occur after weight loss surgery are not detrimental in the elderly population.”

Next steps for research include further studies in the elderly population to examine the physiologic changes that occur after weight loss surgery, said Dr. Dawood. “Being able to characterize the metabolic changes will help in answering the question of whether there is an upper age cut-off for patients undergoing bariatric surgery.”

Global Academy for Medical Education and this news organization are owned by the same parent company. The researchers had no relevant financial conflicts to disclose.

Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.

The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.

Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.

In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
 

Lessons in infectious disease containment

As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.

The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.¹

Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).²

Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:

• Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
• Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
• Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.

The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
 

Senior care in future infectious disease outbreaks

How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.

In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:

1. Identify which populations may be most affected when future outbreaks occur.

2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.³

3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.

4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.

5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.

6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.

7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.

8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.

9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.

10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.

11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.

12. Provide community health care and integration and better coordination of local, state, and national health care.

13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.

Proactive health care outreach

It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.

The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
 

Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at [email protected]. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at [email protected].

References

1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.

2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.

3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.

Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.

The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.

Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.

In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
 

Lessons in infectious disease containment

As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.

The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.¹

Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).²

Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:

• Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
• Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
• Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.

The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
 

Senior care in future infectious disease outbreaks

How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.

In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:

1. Identify which populations may be most affected when future outbreaks occur.

2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.³

3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.

4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.

5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.

6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.

7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.

8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.

9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.

10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.

11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.

12. Provide community health care and integration and better coordination of local, state, and national health care.

13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.

Proactive health care outreach

It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.

The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
 

Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at [email protected]. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at [email protected].

References

1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.

2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.

3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.

Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.

The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.

Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.

In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
 

Lessons in infectious disease containment

As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.

The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.¹

Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).²

Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:

• Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
• Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
• Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.

The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
 

Senior care in future infectious disease outbreaks

How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.

In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:

1. Identify which populations may be most affected when future outbreaks occur.

2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.³

3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.

4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.

5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.

6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.

7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.

8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.

9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.

10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.

11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.

12. Provide community health care and integration and better coordination of local, state, and national health care.

13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.

Proactive health care outreach

It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.

The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
 

Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at [email protected]. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at [email protected].

References

1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.

2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.

3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.

Dairy consumption does not improve bone mineral density (BMD) or reduce the risk of osteoporotic fracture in women starting menopause, a new analysis of the Study of Women’s Health Across the Nation (SWAN) indicates.

copyright/Jupiterimages/Getty Images

And this was regardless of baseline menopausal status, say Taylor Wallace, PhD, of George Mason University, Fairfax, Va., and colleagues in their article published online in Menopause.

“Our previous work indicated a potential premenopausal critical window in regard to the effectiveness of calcium supplements,” they noted.

Clifford Rosen, MD, professor of medicine, Tufts University, Boston, said in an interview that he believes the study reinforces earlier work that dairy intake in women aged 45-55 years does not affect the rate of bone loss or fractures.

“The SWAN study is longitudinal and with sufficient numbers to support their conclusion,” Dr. Rosen said.
 

SWAN study: White women consume the most dairy

As dairy is known to be one of the foremost sources of calcium, along with other bone beneficial nutrients, Dr. Wallace and colleagues decided to examine intake of this food type with long-term bone health using the SWAN data.

The SWAN bone substudy started in 1996 and involved 3,302 pre- or early perimenopausal women aged 42-53 years. The sample size for the annualized rate of BMD loss and fracture analysis involved 1955 women.

A modified food frequency questionnaire was used at baseline, at visit 5, and again at visit 9 to record daily dairy consumption, among many other food items.

“Women were classified into four dairy groups based on this cumulative average dairy intake,” Wallace and colleagues note. Intake was grouped into < 0.5 servings/day; 0.5 to < 1.5 servings/day; 1.5 to < 2.5 servings/day, and ≥ 2.5 servings/day.

“Non-Hispanic white individuals were more likely to consume higher amounts of dairy compared to African American, Chinese, and Japanese individuals,” the authors noted.

They found no significant differences for baseline age, body mass index, femoral neck and lumbar spine BMD, calcium supplement use, or fracture history by dairy intake group.

There were also no differences in the hazard ratios or relative risk of nontraumatic fractures by frequency of daily dairy intake.
 

Findings on dairy and bone are inconsistent

The authors caution that several factors should be taken into account when considering these new findings.

“First, dairy intake was low [overall] among SWAN participants, with 65% reporting consumption of < 1.5 servings/day,” they point out.

Dairy intake was also “particularly low” among racial groups other than whites, which may be due to higher rates of lactose intolerance among ethnic minorities, they speculate.

They previously reported that the use of calcium dietary supplements in SWAN was associated with a lower annualized rate of femoral neck BMD loss as well as BMD loss at the lumbar spine over 10 years of follow-up, mainly in women who were premenopausal at baseline.

But no associations were observed in the risk of bone fracture in any women in that analysis, regardless of menopausal status.

In this new analysis, there were no significant differences in calcium supplement use across the dairy intake groups.

Dr. Wallace and colleagues also noted that the relevance of dairy product intake for bone health has been in question as some observational studies have even “suggested consumption to be associated with an increased risk of fractures.”

The lead author of one of these studies, Karl Michaelsson, MD, PhD, of Uppsala (Sweden) University, said in an interview that his study had looked only at milk intake, and the lack of benefit on bone health from high milk consumption may not apply to all dairy products.

We “may need to look at different types of dairy products,” he said.

Summing up, Stephanie Faubion, MD, MBA, medical director of the North American Menopause Society, said the new SWAN findings do add to the evidence base, “albeit inconsistent ... suggesting a lack of benefit from dairy intake on BMD and fracture risk.”
 

Vitamin D data were not available; dairy may help in this respect

Dr. Rosen also noted that no information was available on vitamin D levels in patients involved in SWAN, which he believes is a limitation of the study.

Nevertheless, “it is important to recognize that elderly individuals who increase their dairy intake may have health benefits as recognized in the Nurses’ Health Study, possibly due to increased protein intake, higher vitamin D levels, or greater calcium intake,” he observed.

A randomized trial of enhanced dairy intake in long-term care residents is currently underway, which should provide answers for a much more vulnerable population than those in the SWAN cohort, Dr. Rosen concluded.

Dr. Wallace has reported serving on the scientific advisory board of the Vitamin Shoppe and has received research support from the National Dairy Council and scientific consulting fees from several food companies. Dr. Rosen has reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Dairy consumption does not improve bone mineral density (BMD) or reduce the risk of osteoporotic fracture in women starting menopause, a new analysis of the Study of Women’s Health Across the Nation (SWAN) indicates.

copyright/Jupiterimages/Getty Images

And this was regardless of baseline menopausal status, say Taylor Wallace, PhD, of George Mason University, Fairfax, Va., and colleagues in their article published online in Menopause.

“Our previous work indicated a potential premenopausal critical window in regard to the effectiveness of calcium supplements,” they noted.

Clifford Rosen, MD, professor of medicine, Tufts University, Boston, said in an interview that he believes the study reinforces earlier work that dairy intake in women aged 45-55 years does not affect the rate of bone loss or fractures.

“The SWAN study is longitudinal and with sufficient numbers to support their conclusion,” Dr. Rosen said.
 

SWAN study: White women consume the most dairy

As dairy is known to be one of the foremost sources of calcium, along with other bone beneficial nutrients, Dr. Wallace and colleagues decided to examine intake of this food type with long-term bone health using the SWAN data.

The SWAN bone substudy started in 1996 and involved 3,302 pre- or early perimenopausal women aged 42-53 years. The sample size for the annualized rate of BMD loss and fracture analysis involved 1955 women.

A modified food frequency questionnaire was used at baseline, at visit 5, and again at visit 9 to record daily dairy consumption, among many other food items.

“Women were classified into four dairy groups based on this cumulative average dairy intake,” Wallace and colleagues note. Intake was grouped into < 0.5 servings/day; 0.5 to < 1.5 servings/day; 1.5 to < 2.5 servings/day, and ≥ 2.5 servings/day.

“Non-Hispanic white individuals were more likely to consume higher amounts of dairy compared to African American, Chinese, and Japanese individuals,” the authors noted.

They found no significant differences for baseline age, body mass index, femoral neck and lumbar spine BMD, calcium supplement use, or fracture history by dairy intake group.

There were also no differences in the hazard ratios or relative risk of nontraumatic fractures by frequency of daily dairy intake.
 

Findings on dairy and bone are inconsistent

The authors caution that several factors should be taken into account when considering these new findings.

“First, dairy intake was low [overall] among SWAN participants, with 65% reporting consumption of < 1.5 servings/day,” they point out.

Dairy intake was also “particularly low” among racial groups other than whites, which may be due to higher rates of lactose intolerance among ethnic minorities, they speculate.

They previously reported that the use of calcium dietary supplements in SWAN was associated with a lower annualized rate of femoral neck BMD loss as well as BMD loss at the lumbar spine over 10 years of follow-up, mainly in women who were premenopausal at baseline.

But no associations were observed in the risk of bone fracture in any women in that analysis, regardless of menopausal status.

In this new analysis, there were no significant differences in calcium supplement use across the dairy intake groups.

Dr. Wallace and colleagues also noted that the relevance of dairy product intake for bone health has been in question as some observational studies have even “suggested consumption to be associated with an increased risk of fractures.”

The lead author of one of these studies, Karl Michaelsson, MD, PhD, of Uppsala (Sweden) University, said in an interview that his study had looked only at milk intake, and the lack of benefit on bone health from high milk consumption may not apply to all dairy products.

We “may need to look at different types of dairy products,” he said.

Summing up, Stephanie Faubion, MD, MBA, medical director of the North American Menopause Society, said the new SWAN findings do add to the evidence base, “albeit inconsistent ... suggesting a lack of benefit from dairy intake on BMD and fracture risk.”
 

Vitamin D data were not available; dairy may help in this respect

Dr. Rosen also noted that no information was available on vitamin D levels in patients involved in SWAN, which he believes is a limitation of the study.

Nevertheless, “it is important to recognize that elderly individuals who increase their dairy intake may have health benefits as recognized in the Nurses’ Health Study, possibly due to increased protein intake, higher vitamin D levels, or greater calcium intake,” he observed.

A randomized trial of enhanced dairy intake in long-term care residents is currently underway, which should provide answers for a much more vulnerable population than those in the SWAN cohort, Dr. Rosen concluded.

Dr. Wallace has reported serving on the scientific advisory board of the Vitamin Shoppe and has received research support from the National Dairy Council and scientific consulting fees from several food companies. Dr. Rosen has reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Dairy consumption does not improve bone mineral density (BMD) or reduce the risk of osteoporotic fracture in women starting menopause, a new analysis of the Study of Women’s Health Across the Nation (SWAN) indicates.

copyright/Jupiterimages/Getty Images

And this was regardless of baseline menopausal status, say Taylor Wallace, PhD, of George Mason University, Fairfax, Va., and colleagues in their article published online in Menopause.

“Our previous work indicated a potential premenopausal critical window in regard to the effectiveness of calcium supplements,” they noted.

Clifford Rosen, MD, professor of medicine, Tufts University, Boston, said in an interview that he believes the study reinforces earlier work that dairy intake in women aged 45-55 years does not affect the rate of bone loss or fractures.

“The SWAN study is longitudinal and with sufficient numbers to support their conclusion,” Dr. Rosen said.
 

SWAN study: White women consume the most dairy

As dairy is known to be one of the foremost sources of calcium, along with other bone beneficial nutrients, Dr. Wallace and colleagues decided to examine intake of this food type with long-term bone health using the SWAN data.

The SWAN bone substudy started in 1996 and involved 3,302 pre- or early perimenopausal women aged 42-53 years. The sample size for the annualized rate of BMD loss and fracture analysis involved 1955 women.

A modified food frequency questionnaire was used at baseline, at visit 5, and again at visit 9 to record daily dairy consumption, among many other food items.

“Women were classified into four dairy groups based on this cumulative average dairy intake,” Wallace and colleagues note. Intake was grouped into < 0.5 servings/day; 0.5 to < 1.5 servings/day; 1.5 to < 2.5 servings/day, and ≥ 2.5 servings/day.

“Non-Hispanic white individuals were more likely to consume higher amounts of dairy compared to African American, Chinese, and Japanese individuals,” the authors noted.

They found no significant differences for baseline age, body mass index, femoral neck and lumbar spine BMD, calcium supplement use, or fracture history by dairy intake group.

There were also no differences in the hazard ratios or relative risk of nontraumatic fractures by frequency of daily dairy intake.
 

Findings on dairy and bone are inconsistent

The authors caution that several factors should be taken into account when considering these new findings.

“First, dairy intake was low [overall] among SWAN participants, with 65% reporting consumption of < 1.5 servings/day,” they point out.

Dairy intake was also “particularly low” among racial groups other than whites, which may be due to higher rates of lactose intolerance among ethnic minorities, they speculate.

They previously reported that the use of calcium dietary supplements in SWAN was associated with a lower annualized rate of femoral neck BMD loss as well as BMD loss at the lumbar spine over 10 years of follow-up, mainly in women who were premenopausal at baseline.

But no associations were observed in the risk of bone fracture in any women in that analysis, regardless of menopausal status.

In this new analysis, there were no significant differences in calcium supplement use across the dairy intake groups.

Dr. Wallace and colleagues also noted that the relevance of dairy product intake for bone health has been in question as some observational studies have even “suggested consumption to be associated with an increased risk of fractures.”

The lead author of one of these studies, Karl Michaelsson, MD, PhD, of Uppsala (Sweden) University, said in an interview that his study had looked only at milk intake, and the lack of benefit on bone health from high milk consumption may not apply to all dairy products.

We “may need to look at different types of dairy products,” he said.

Summing up, Stephanie Faubion, MD, MBA, medical director of the North American Menopause Society, said the new SWAN findings do add to the evidence base, “albeit inconsistent ... suggesting a lack of benefit from dairy intake on BMD and fracture risk.”
 

Vitamin D data were not available; dairy may help in this respect

Dr. Rosen also noted that no information was available on vitamin D levels in patients involved in SWAN, which he believes is a limitation of the study.

Nevertheless, “it is important to recognize that elderly individuals who increase their dairy intake may have health benefits as recognized in the Nurses’ Health Study, possibly due to increased protein intake, higher vitamin D levels, or greater calcium intake,” he observed.

A randomized trial of enhanced dairy intake in long-term care residents is currently underway, which should provide answers for a much more vulnerable population than those in the SWAN cohort, Dr. Rosen concluded.

Dr. Wallace has reported serving on the scientific advisory board of the Vitamin Shoppe and has received research support from the National Dairy Council and scientific consulting fees from several food companies. Dr. Rosen has reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

ILLUSTRATIVE CASE

Ms. M is a 76-year-old woman with well-­controlled type 2 diabetes mellitus for 10 years and well-controlled mild hypertension. She is otherwise healthy, and her mother lived to age 95. Ms. M has never smoked, has no previous history of vascular/cardiovascular disease, and drinks 1 glass of wine 2 to 3 times per week. Based on the American College of Cardiology (ACC) calculator, she was started on atorvastatin years ago. Is continued use of the medication of any benefit at her current age?

The 2018 American Heart Association (AHA)/ACC/Multi-Society cholesterol guidelines do not provide primary prevention recommendations for those older than age 75 years.³ Up to age 75, the guidelines recommend that patients with type 2 diabetes and a low-density lipoprotein cholesterol (LDL-C) level ≥ 70 mg/dL, as well as those without diabetes but with an LDL-C ≥ 70 mg/dL and a 10-year atherosclerotic cardiovascular disease (ASCVD) risk ≥ 10%, be started on medium-intensity statin therapy.

A 2018 consensus panel review of the current literature, sponsored by the National Institute on Aging and the National Heart, Lung, and Blood Institute, concluded that there was insufficient evidence regarding the benefits and harms of statins in older adults, especially those with comorbidities, and that there was a paucity of evidence about statin therapy outcomes (both adverse and beneficial) relevant to older adults.⁴

A review of all guidelines published since 2013 revealed that only the United Kingdom’s 2014 National Institute for Health and Care Excellence (NICE) guideline provides a strong, risk-based recommendation for initiating primary prevention with statins in patients > 75 years old.⁵ These recommendations are based on the QRISK2 calculator (which has since been updated to the QRISK3), which assigns everyone ages > 75 years a > 10% 10-year risk score. This provides a universal statin indication for anyone in the 76-to-84 age range.⁶

Both the ACC/AHA and US Preventive Services Task Force guidelines clearly state that there are too few data and inadequate evidence in people older than 75 for a strong, risk-based statin recommendation.⁵ The Canadian Cardiovascular Society guideline takes a similar stance, emphasizing that the recommended Framingham risk model is not well validated in people > 75 years.⁵

STUDY SUMMARIES

Two different looks at statin use in the elderly

A retrospective cohort study (N = 46,864; median follow-up, 5.6 years) examined whether statin treatment is associated with a reduction in atherosclerotic disease and mortality in old and very old adults with and without type 2 diabetes.¹ Patients were enrolled from a large, anonymized national database in Spain. The researchers looked only at first-time users of statins and those without a statin prescription within the past 18 months.

Statin therapy seems to provide no benefit to patients ages > 75 years without ASCVD or in patients ages ≥ 85 years without ASCVD, regardless of type 2 diabetes status.

Patients with previous ASCVD, type 1 diabetes, previous lipid-lowering treatment, dementia, cancer, or paralysis were excluded, as were those who were in residential care, were on dialysis, or had received an organ transplant. Patients were stratified by age (75-84 years and ≥ 85 years), diabetes status (with or without type 2 diabetes), and statin use (nonuser or new user).

Continue to: Results

Results. For patients with type 2 diabetes, the risk of ASCVD (a composite of coronary heart disease and stroke) was lower among those who took statins than among those who did not in the 75-to-84 group (hazard ratio [HR] = 0.76; 95% confidence interval [CI], 0.65-0.89; 1-year number needed to treat [NNT] = 164). Among those who took statins, there was also lower all-cause mortality (HR = 0.84; 95% CI, 0.75-0.94; 1-year NNT = 306). In those ages ≥ 85 years with diabetes, the statin group did not have a lower risk of ASCVD (HR = 0.82; 95% CI, 0.53-1.26) or all-cause mortality (HR = 1.05; 95% CI, 0.86-1.28).

For patients ages 75 to 84 years without diabetes, there was no difference in risk between groups for ASCVD (HR = 0.94; 95% CI, 0.86–1.04) or all-cause mortality (HR = 0.98; 95% CI, 0.91-1.05). In those ages ≥ 85 years without diabetes, there was also no difference between groups for ASCVD (HR = 1; 95% CI, 0.80-1.24) or for all-cause mortality (HR = 1; 95% CI, 0.90-1.11).

A 2019 meta-analysis of randomized controlled trials (RCTs) (n = 134,537) and RCT summary data (n = 12,705) evaluated the safety and efficacy of statin therapy in patients ages ≥ 55 years.² In the group of patients ages > 75 years (n = 14,483; median follow-up, 4.9 years), each 1 mmol/L reduction in LDL-C was associated with significant decreased risk for major vascular events (risk ratio [RR] = 0.82; 95% CI, 0.70-0.95) and for major coronary events (RR = 0.82; 95% CI, 0.70-0.96).

In subgroup analysis by the presence or absence of previous vascular disease, there was a decreased risk per 1 mmol/L LDL-C reduction of major vascular events in patients with previous vascular disease (RR = 0.85; 95% CI, 0.73-0.98); however, there was not a significant effect in patients without previous vascular disease (RR = 0.92; 95% CI, 0.73-1.16).

WHAT’S NEW

Statins may be unnecessary in older adults without ASCVD or T2DM

Statin therapy reduces the risk of ASCVD and mortality in patients ages 75 to 84 with type 2 diabetes and in patients > 75 years with known vascular disease. However, statin therapy seems to provide no benefit in patients ages > 75 years without ASCVD or in patients ages ≥ 85 years without ASCVD, regardless of type 2 diabetes status.

Continue to: CAVEATS

CAVEATS

Retrospective cohort design leaves cause and effect equivocal

Even though the first study was large (with more than 46,000 patients) and the median follow-up was 5.6 years, it was a retrospective cohort study. While there is clearly an association between statin therapy and reduced ASCVD and all-cause mortality in patients with diabetes ages 75 to 84 years, cause and effect cannot be unequivocally stated. However, the meta-analysis, which included RCTs, confirms the benefit of statins in secondary prevention for older patients.

The cohort study did not look at adverse effects from statin therapy in this age group, but the data from the 2019 meta-analysis did not reveal any significant risk of myopathy.

CHALLENGES TO IMPLEMENTATION

Guidelines are lacking and discontinuing meds requires discussion

The lack of supporting guidelines to treat this age group with statins remains the largest barrier to implementation. Many patients may already be taking a statin, so a discussion about discontinuing medication will need to be initiated.

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

Ms. M is a 76-year-old woman with well-­controlled type 2 diabetes mellitus for 10 years and well-controlled mild hypertension. She is otherwise healthy, and her mother lived to age 95. Ms. M has never smoked, has no previous history of vascular/cardiovascular disease, and drinks 1 glass of wine 2 to 3 times per week. Based on the American College of Cardiology (ACC) calculator, she was started on atorvastatin years ago. Is continued use of the medication of any benefit at her current age?

The 2018 American Heart Association (AHA)/ACC/Multi-Society cholesterol guidelines do not provide primary prevention recommendations for those older than age 75 years.³ Up to age 75, the guidelines recommend that patients with type 2 diabetes and a low-density lipoprotein cholesterol (LDL-C) level ≥ 70 mg/dL, as well as those without diabetes but with an LDL-C ≥ 70 mg/dL and a 10-year atherosclerotic cardiovascular disease (ASCVD) risk ≥ 10%, be started on medium-intensity statin therapy.

A 2018 consensus panel review of the current literature, sponsored by the National Institute on Aging and the National Heart, Lung, and Blood Institute, concluded that there was insufficient evidence regarding the benefits and harms of statins in older adults, especially those with comorbidities, and that there was a paucity of evidence about statin therapy outcomes (both adverse and beneficial) relevant to older adults.⁴

A review of all guidelines published since 2013 revealed that only the United Kingdom’s 2014 National Institute for Health and Care Excellence (NICE) guideline provides a strong, risk-based recommendation for initiating primary prevention with statins in patients > 75 years old.⁵ These recommendations are based on the QRISK2 calculator (which has since been updated to the QRISK3), which assigns everyone ages > 75 years a > 10% 10-year risk score. This provides a universal statin indication for anyone in the 76-to-84 age range.⁶

Both the ACC/AHA and US Preventive Services Task Force guidelines clearly state that there are too few data and inadequate evidence in people older than 75 for a strong, risk-based statin recommendation.⁵ The Canadian Cardiovascular Society guideline takes a similar stance, emphasizing that the recommended Framingham risk model is not well validated in people > 75 years.⁵

STUDY SUMMARIES

Two different looks at statin use in the elderly

A retrospective cohort study (N = 46,864; median follow-up, 5.6 years) examined whether statin treatment is associated with a reduction in atherosclerotic disease and mortality in old and very old adults with and without type 2 diabetes.¹ Patients were enrolled from a large, anonymized national database in Spain. The researchers looked only at first-time users of statins and those without a statin prescription within the past 18 months.

Statin therapy seems to provide no benefit to patients ages > 75 years without ASCVD or in patients ages ≥ 85 years without ASCVD, regardless of type 2 diabetes status.

Patients with previous ASCVD, type 1 diabetes, previous lipid-lowering treatment, dementia, cancer, or paralysis were excluded, as were those who were in residential care, were on dialysis, or had received an organ transplant. Patients were stratified by age (75-84 years and ≥ 85 years), diabetes status (with or without type 2 diabetes), and statin use (nonuser or new user).

Continue to: Results

Results. For patients with type 2 diabetes, the risk of ASCVD (a composite of coronary heart disease and stroke) was lower among those who took statins than among those who did not in the 75-to-84 group (hazard ratio [HR] = 0.76; 95% confidence interval [CI], 0.65-0.89; 1-year number needed to treat [NNT] = 164). Among those who took statins, there was also lower all-cause mortality (HR = 0.84; 95% CI, 0.75-0.94; 1-year NNT = 306). In those ages ≥ 85 years with diabetes, the statin group did not have a lower risk of ASCVD (HR = 0.82; 95% CI, 0.53-1.26) or all-cause mortality (HR = 1.05; 95% CI, 0.86-1.28).

For patients ages 75 to 84 years without diabetes, there was no difference in risk between groups for ASCVD (HR = 0.94; 95% CI, 0.86–1.04) or all-cause mortality (HR = 0.98; 95% CI, 0.91-1.05). In those ages ≥ 85 years without diabetes, there was also no difference between groups for ASCVD (HR = 1; 95% CI, 0.80-1.24) or for all-cause mortality (HR = 1; 95% CI, 0.90-1.11).

A 2019 meta-analysis of randomized controlled trials (RCTs) (n = 134,537) and RCT summary data (n = 12,705) evaluated the safety and efficacy of statin therapy in patients ages ≥ 55 years.² In the group of patients ages > 75 years (n = 14,483; median follow-up, 4.9 years), each 1 mmol/L reduction in LDL-C was associated with significant decreased risk for major vascular events (risk ratio [RR] = 0.82; 95% CI, 0.70-0.95) and for major coronary events (RR = 0.82; 95% CI, 0.70-0.96).

In subgroup analysis by the presence or absence of previous vascular disease, there was a decreased risk per 1 mmol/L LDL-C reduction of major vascular events in patients with previous vascular disease (RR = 0.85; 95% CI, 0.73-0.98); however, there was not a significant effect in patients without previous vascular disease (RR = 0.92; 95% CI, 0.73-1.16).

WHAT’S NEW

Statins may be unnecessary in older adults without ASCVD or T2DM

Statin therapy reduces the risk of ASCVD and mortality in patients ages 75 to 84 with type 2 diabetes and in patients > 75 years with known vascular disease. However, statin therapy seems to provide no benefit in patients ages > 75 years without ASCVD or in patients ages ≥ 85 years without ASCVD, regardless of type 2 diabetes status.

Continue to: CAVEATS

CAVEATS

Retrospective cohort design leaves cause and effect equivocal

Even though the first study was large (with more than 46,000 patients) and the median follow-up was 5.6 years, it was a retrospective cohort study. While there is clearly an association between statin therapy and reduced ASCVD and all-cause mortality in patients with diabetes ages 75 to 84 years, cause and effect cannot be unequivocally stated. However, the meta-analysis, which included RCTs, confirms the benefit of statins in secondary prevention for older patients.

The cohort study did not look at adverse effects from statin therapy in this age group, but the data from the 2019 meta-analysis did not reveal any significant risk of myopathy.

CHALLENGES TO IMPLEMENTATION

Guidelines are lacking and discontinuing meds requires discussion

The lack of supporting guidelines to treat this age group with statins remains the largest barrier to implementation. Many patients may already be taking a statin, so a discussion about discontinuing medication will need to be initiated.

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

Ms. M is a 76-year-old woman with well-­controlled type 2 diabetes mellitus for 10 years and well-controlled mild hypertension. She is otherwise healthy, and her mother lived to age 95. Ms. M has never smoked, has no previous history of vascular/cardiovascular disease, and drinks 1 glass of wine 2 to 3 times per week. Based on the American College of Cardiology (ACC) calculator, she was started on atorvastatin years ago. Is continued use of the medication of any benefit at her current age?

The 2018 American Heart Association (AHA)/ACC/Multi-Society cholesterol guidelines do not provide primary prevention recommendations for those older than age 75 years.³ Up to age 75, the guidelines recommend that patients with type 2 diabetes and a low-density lipoprotein cholesterol (LDL-C) level ≥ 70 mg/dL, as well as those without diabetes but with an LDL-C ≥ 70 mg/dL and a 10-year atherosclerotic cardiovascular disease (ASCVD) risk ≥ 10%, be started on medium-intensity statin therapy.

A 2018 consensus panel review of the current literature, sponsored by the National Institute on Aging and the National Heart, Lung, and Blood Institute, concluded that there was insufficient evidence regarding the benefits and harms of statins in older adults, especially those with comorbidities, and that there was a paucity of evidence about statin therapy outcomes (both adverse and beneficial) relevant to older adults.⁴

A review of all guidelines published since 2013 revealed that only the United Kingdom’s 2014 National Institute for Health and Care Excellence (NICE) guideline provides a strong, risk-based recommendation for initiating primary prevention with statins in patients > 75 years old.⁵ These recommendations are based on the QRISK2 calculator (which has since been updated to the QRISK3), which assigns everyone ages > 75 years a > 10% 10-year risk score. This provides a universal statin indication for anyone in the 76-to-84 age range.⁶

Both the ACC/AHA and US Preventive Services Task Force guidelines clearly state that there are too few data and inadequate evidence in people older than 75 for a strong, risk-based statin recommendation.⁵ The Canadian Cardiovascular Society guideline takes a similar stance, emphasizing that the recommended Framingham risk model is not well validated in people > 75 years.⁵

STUDY SUMMARIES

Two different looks at statin use in the elderly

A retrospective cohort study (N = 46,864; median follow-up, 5.6 years) examined whether statin treatment is associated with a reduction in atherosclerotic disease and mortality in old and very old adults with and without type 2 diabetes.¹ Patients were enrolled from a large, anonymized national database in Spain. The researchers looked only at first-time users of statins and those without a statin prescription within the past 18 months.

Statin therapy seems to provide no benefit to patients ages > 75 years without ASCVD or in patients ages ≥ 85 years without ASCVD, regardless of type 2 diabetes status.

Patients with previous ASCVD, type 1 diabetes, previous lipid-lowering treatment, dementia, cancer, or paralysis were excluded, as were those who were in residential care, were on dialysis, or had received an organ transplant. Patients were stratified by age (75-84 years and ≥ 85 years), diabetes status (with or without type 2 diabetes), and statin use (nonuser or new user).

Continue to: Results

Results. For patients with type 2 diabetes, the risk of ASCVD (a composite of coronary heart disease and stroke) was lower among those who took statins than among those who did not in the 75-to-84 group (hazard ratio [HR] = 0.76; 95% confidence interval [CI], 0.65-0.89; 1-year number needed to treat [NNT] = 164). Among those who took statins, there was also lower all-cause mortality (HR = 0.84; 95% CI, 0.75-0.94; 1-year NNT = 306). In those ages ≥ 85 years with diabetes, the statin group did not have a lower risk of ASCVD (HR = 0.82; 95% CI, 0.53-1.26) or all-cause mortality (HR = 1.05; 95% CI, 0.86-1.28).

For patients ages 75 to 84 years without diabetes, there was no difference in risk between groups for ASCVD (HR = 0.94; 95% CI, 0.86–1.04) or all-cause mortality (HR = 0.98; 95% CI, 0.91-1.05). In those ages ≥ 85 years without diabetes, there was also no difference between groups for ASCVD (HR = 1; 95% CI, 0.80-1.24) or for all-cause mortality (HR = 1; 95% CI, 0.90-1.11).

A 2019 meta-analysis of randomized controlled trials (RCTs) (n = 134,537) and RCT summary data (n = 12,705) evaluated the safety and efficacy of statin therapy in patients ages ≥ 55 years.² In the group of patients ages > 75 years (n = 14,483; median follow-up, 4.9 years), each 1 mmol/L reduction in LDL-C was associated with significant decreased risk for major vascular events (risk ratio [RR] = 0.82; 95% CI, 0.70-0.95) and for major coronary events (RR = 0.82; 95% CI, 0.70-0.96).

In subgroup analysis by the presence or absence of previous vascular disease, there was a decreased risk per 1 mmol/L LDL-C reduction of major vascular events in patients with previous vascular disease (RR = 0.85; 95% CI, 0.73-0.98); however, there was not a significant effect in patients without previous vascular disease (RR = 0.92; 95% CI, 0.73-1.16).

WHAT’S NEW

Statins may be unnecessary in older adults without ASCVD or T2DM

Statin therapy reduces the risk of ASCVD and mortality in patients ages 75 to 84 with type 2 diabetes and in patients > 75 years with known vascular disease. However, statin therapy seems to provide no benefit in patients ages > 75 years without ASCVD or in patients ages ≥ 85 years without ASCVD, regardless of type 2 diabetes status.

Continue to: CAVEATS

CAVEATS

Retrospective cohort design leaves cause and effect equivocal

Even though the first study was large (with more than 46,000 patients) and the median follow-up was 5.6 years, it was a retrospective cohort study. While there is clearly an association between statin therapy and reduced ASCVD and all-cause mortality in patients with diabetes ages 75 to 84 years, cause and effect cannot be unequivocally stated. However, the meta-analysis, which included RCTs, confirms the benefit of statins in secondary prevention for older patients.

The cohort study did not look at adverse effects from statin therapy in this age group, but the data from the 2019 meta-analysis did not reveal any significant risk of myopathy.

CHALLENGES TO IMPLEMENTATION

Guidelines are lacking and discontinuing meds requires discussion

The lack of supporting guidelines to treat this age group with statins remains the largest barrier to implementation. Many patients may already be taking a statin, so a discussion about discontinuing medication will need to be initiated.

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

A treatment schedule of very attenuated chemotherapy using standard drugs is feasible and effective in frail and elderly patients with acute lymphoblastic leukemia (ALL), according to a prospective study published in Clinical Lymphoma, Myeloma & Leukemia.

VashiDonsk/Creative Commons/CC ASA 3.0

The study comprised 67 previously untreated patients with B- or T-lineage Philadelphia chromosome–negative ALL from 30 Spanish hospitals who were enrolled in the prospective, multicenter ALL-07FRAIL trial (NCT01358201) from the Spanish PETHEMA (Programa Español de Tratamientos en Hematologia) group from January 2008 to October 2019.

The median patient age in this analysis was 67 years and 51 patients (76%) were older than 70 years. The median Charlson Comorbidity Index was 5, with the main comorbidities being cardiovascular (47 patients), other neoplasia (24), diabetes (17), and very advanced age (>80 years; 12).

The attenuated treatment regimen consisted of a prephase with dexamethasone and intrathecal therapy with methotrexate was given for a maximum of 1 week. Then weekly induction therapy consisted of weekly vincristine (capped at 1 mg/week) and daily dexamethasone with a progressively decreasing dose along 4 weeks, as well as two additional doses of intrathecal methotrexate.

Those patients who achieved complete remission received maintenance therapy with mercaptopurine and methotrexate to complete 2 years of treatment. In addition, reinduction pulses with vincristine and dexamethasone were given every 3 months during the first year, according to Josep-Maria Ribera, MD, of the Universitat Autònoma de Barcelona, Badalona, Spain and colleagues on behalf of the PETHEMA group of the Spanish Society of Hematology.

The complete remission rate was 54% (36/67 patients). The median disease-free survival and overall survival were 6.9 months and 7.6 months, respectively.

Of the 32 patients who initiated maintenance therapy, 5 patients died of infection (2), hemorrhage (2), and acute cognitive impairment (1), and 23 relapsed, with a cumulative incidence of relapse of 74% and a median time to relapse of 12.3 months.

The most frequent toxic events reported were hematologic (neutropenia 77% and thrombocytopenia 54%, of grade III-IV in all cases) followed by infections, metabolic (mainly hyperglycemia), and neurologic, according to the researchers.

“The lack of similar trials specifically directed to this frail population is one of the major strengths of this study, and we consider that this minimal chemotherapy approach could be used as a backbone for addition of immuno/targeted therapy in this subset of infirm patients,” the researchers concluded.

The study was supported by the CERCA Program/Generalitat de Catalunya and the Josep Carreras Leukemia Research Institute. The authors reported having no disclosures.

[email protected]

SOURCE: Ribera J-M et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 5. doi: 10.1016/j.clml.2020.03.011.

A treatment schedule of very attenuated chemotherapy using standard drugs is feasible and effective in frail and elderly patients with acute lymphoblastic leukemia (ALL), according to a prospective study published in Clinical Lymphoma, Myeloma & Leukemia.

VashiDonsk/Creative Commons/CC ASA 3.0

The study comprised 67 previously untreated patients with B- or T-lineage Philadelphia chromosome–negative ALL from 30 Spanish hospitals who were enrolled in the prospective, multicenter ALL-07FRAIL trial (NCT01358201) from the Spanish PETHEMA (Programa Español de Tratamientos en Hematologia) group from January 2008 to October 2019.

The median patient age in this analysis was 67 years and 51 patients (76%) were older than 70 years. The median Charlson Comorbidity Index was 5, with the main comorbidities being cardiovascular (47 patients), other neoplasia (24), diabetes (17), and very advanced age (>80 years; 12).

The attenuated treatment regimen consisted of a prephase with dexamethasone and intrathecal therapy with methotrexate was given for a maximum of 1 week. Then weekly induction therapy consisted of weekly vincristine (capped at 1 mg/week) and daily dexamethasone with a progressively decreasing dose along 4 weeks, as well as two additional doses of intrathecal methotrexate.

Those patients who achieved complete remission received maintenance therapy with mercaptopurine and methotrexate to complete 2 years of treatment. In addition, reinduction pulses with vincristine and dexamethasone were given every 3 months during the first year, according to Josep-Maria Ribera, MD, of the Universitat Autònoma de Barcelona, Badalona, Spain and colleagues on behalf of the PETHEMA group of the Spanish Society of Hematology.

The complete remission rate was 54% (36/67 patients). The median disease-free survival and overall survival were 6.9 months and 7.6 months, respectively.

Of the 32 patients who initiated maintenance therapy, 5 patients died of infection (2), hemorrhage (2), and acute cognitive impairment (1), and 23 relapsed, with a cumulative incidence of relapse of 74% and a median time to relapse of 12.3 months.

The most frequent toxic events reported were hematologic (neutropenia 77% and thrombocytopenia 54%, of grade III-IV in all cases) followed by infections, metabolic (mainly hyperglycemia), and neurologic, according to the researchers.

“The lack of similar trials specifically directed to this frail population is one of the major strengths of this study, and we consider that this minimal chemotherapy approach could be used as a backbone for addition of immuno/targeted therapy in this subset of infirm patients,” the researchers concluded.

The study was supported by the CERCA Program/Generalitat de Catalunya and the Josep Carreras Leukemia Research Institute. The authors reported having no disclosures.

[email protected]

SOURCE: Ribera J-M et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 5. doi: 10.1016/j.clml.2020.03.011.

A treatment schedule of very attenuated chemotherapy using standard drugs is feasible and effective in frail and elderly patients with acute lymphoblastic leukemia (ALL), according to a prospective study published in Clinical Lymphoma, Myeloma & Leukemia.

VashiDonsk/Creative Commons/CC ASA 3.0

The study comprised 67 previously untreated patients with B- or T-lineage Philadelphia chromosome–negative ALL from 30 Spanish hospitals who were enrolled in the prospective, multicenter ALL-07FRAIL trial (NCT01358201) from the Spanish PETHEMA (Programa Español de Tratamientos en Hematologia) group from January 2008 to October 2019.

The median patient age in this analysis was 67 years and 51 patients (76%) were older than 70 years. The median Charlson Comorbidity Index was 5, with the main comorbidities being cardiovascular (47 patients), other neoplasia (24), diabetes (17), and very advanced age (>80 years; 12).

The attenuated treatment regimen consisted of a prephase with dexamethasone and intrathecal therapy with methotrexate was given for a maximum of 1 week. Then weekly induction therapy consisted of weekly vincristine (capped at 1 mg/week) and daily dexamethasone with a progressively decreasing dose along 4 weeks, as well as two additional doses of intrathecal methotrexate.

Those patients who achieved complete remission received maintenance therapy with mercaptopurine and methotrexate to complete 2 years of treatment. In addition, reinduction pulses with vincristine and dexamethasone were given every 3 months during the first year, according to Josep-Maria Ribera, MD, of the Universitat Autònoma de Barcelona, Badalona, Spain and colleagues on behalf of the PETHEMA group of the Spanish Society of Hematology.

The complete remission rate was 54% (36/67 patients). The median disease-free survival and overall survival were 6.9 months and 7.6 months, respectively.

Of the 32 patients who initiated maintenance therapy, 5 patients died of infection (2), hemorrhage (2), and acute cognitive impairment (1), and 23 relapsed, with a cumulative incidence of relapse of 74% and a median time to relapse of 12.3 months.

The most frequent toxic events reported were hematologic (neutropenia 77% and thrombocytopenia 54%, of grade III-IV in all cases) followed by infections, metabolic (mainly hyperglycemia), and neurologic, according to the researchers.

“The lack of similar trials specifically directed to this frail population is one of the major strengths of this study, and we consider that this minimal chemotherapy approach could be used as a backbone for addition of immuno/targeted therapy in this subset of infirm patients,” the researchers concluded.

The study was supported by the CERCA Program/Generalitat de Catalunya and the Josep Carreras Leukemia Research Institute. The authors reported having no disclosures.

[email protected]

SOURCE: Ribera J-M et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 5. doi: 10.1016/j.clml.2020.03.011.

One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.

iofoto/Thinkstock

“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.

“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”

Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.

This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
 

Impact on mental health, cognition

Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.

“A striking finding is that lack of social interaction is associated with incident dementia. Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.

INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.

“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.

Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.

“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.

People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.

“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.

A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.

It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.

“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.

The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.

“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.

“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
 

The fire next time

The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.

“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.

“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.

Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.

“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.

The speakers indicated they had no financial conflicts regarding their presentations.

[email protected]

One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.

iofoto/Thinkstock

“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.

“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”

Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.

This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
 

Impact on mental health, cognition

Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.

“A striking finding is that lack of social interaction is associated with incident dementia. Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.

INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.

“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.

Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.

“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.

People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.

“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.

A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.

It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.

“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.

The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.

“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.

“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
 

The fire next time

The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.

“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.

“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.

Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.

“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.

The speakers indicated they had no financial conflicts regarding their presentations.

[email protected]

One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.

iofoto/Thinkstock

“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.

“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”

Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.

This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
 

Impact on mental health, cognition

Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.

“A striking finding is that lack of social interaction is associated with incident dementia. Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.

INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.

“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.

Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.

“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.

People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.

“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.

A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.

It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.

“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.

The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.

“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.

“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
 

The fire next time

The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.

“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.

“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.

Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.

“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.

The speakers indicated they had no financial conflicts regarding their presentations.

[email protected]

Among patients with atrial fibrillation, use of direct oral anticoagulants is linked to lower osteoporotic fracture risk versus warfarin, results of a recent population-based cohort study show.

iStock/Thinkstock

The choice of direct oral anticoagulant (DOAC) didn’t appear to have an impact, as each individual agent yielded a substantially lower risk of fracture versus the vitamin K antagonist, with risk reductions ranging from 38% to 48%, according to the study authors.

This is one of the latest reports to suggest DOACs could have an edge over warfarin for preventing fractures, providing new evidence that “may help inform the benefit risk assessment” when it comes to choosing an anticoagulant for a patient with atrial fibrillation (AFib) in the clinic, wrote the authors, led by Wallis C.Y. Lau, PhD, with the University College London.

“There exists a compelling case for evaluating whether the risk for osteoporotic fractures should be considered at the point of prescribing an oral anticoagulant to minimize fracture risk,” Dr. Lau and coauthors wrote in a report on the study that appears in Annals of Internal Medicine.

The case is especially compelling since fracture risk is “often neglected” when choosing an anticoagulant, the authors wrote. Surgeries to treat fracture are difficult because of the need for perioperative management of anticoagulation as “a balance between the risk for stroke and excessive bleeding must be achieved,” they added.

Based on these data, physicians should strongly consider DOACs as an alternative to vitamin K antagonists to reduce the risk of osteoporosis over the long term in patients with AFib, according to Victor Lawrence Roberts, MD, a Florida endocrinologist.

“Osteoporosis takes years, sometimes decades to develop, and if you then overlay warfarin on top of a readily evolving metabolic bone disease, you probably accelerate that process, said Dr. Roberts, professor of internal medicine at the University of Central Florida, Orlando, and editorial advisory board member of Internal Medicine News.

There’s a considerable amount of concerning preclinical data that warfarin could increase osteoporotic fracture risk. Of note, vitamin K antagonists modulate osteocalcin, a calcium-binding bone matrix protein, Dr. Roberts said.

“Osteocalcin is important for bone metabolism and health, and inhibiting osteocalcin will inhibit the ability to have a healthy bone matrix,” he explained.

The impact of anticoagulants on fracture risk is particularly relevant to patients with AFib, according to Dr. Lau and colleagues, who referenced one 2017 report showing a higher incidence of hip fracture among AFib patients versus those without AFib.

In their more recent study, Dr. Lau and colleagues reviewed electronic health records in a Hong Kong database for 23,515 older adults with a new diagnosis of AFib who received a new prescription of warfarin or DOACs including apixaban, dabigatran, or rivaroxaban.

DOAC use was consistently associated with a lower risk of osteoporotic fractures versus warfarin, regardless of the DOAC considered. The hazard ratios were 0.62 (95% confidence interval, 0.41-0.94) for apixaban, 0.65 (95% CI, 0.49-0.86) for dabigatran, and 0.52 (95% CI, 0.37-0.73) for rivaroxaban versus warfarin, the report showed.

Head-to-head comparisons between DOACS didn’t yield any statistically significant differences, though the analyses were underpowered in this respect, according to the investigators.

“This study can only rule out more than a twofold higher or a 50% lower relative risk for osteoporotic fractures between individual DOACs,” they wrote. “However, any absolute risk differences were small and would likely be of minor clinical significance.”

The reduced risk of fracture for DOACs versus warfarin was consistent in men and women with AFib, suggesting that women may particularly benefit from DOACs, given that they have a higher risk of fracture than men, the investigators added.

The results of this study suggest yet another benefit of DOACs over warfarin in patients with AFib, according to internist Noel Deep, MD, who is the chief medical officer of Aspirus Langlade Hospital in Antigo, Wisconsin.

“The lower risk of osteoporotic fractures with DOACS, in addition to other advantages such as lower risk of intracranial bleeding, once- or twice-daily consistent dosing, no dietary restrictions, and no blood tests to regulate the dose might be another reason that physicians may favor them over warfarin in older individuals requiring anticoagulation,” Dr. Deep said in an interview.

Results of this and several other recent studies may help in recommending DOACs to internal medicine patients who have a diagnosis of AFib requiring anticoagulation, according to Dr. Deep, who is also a physician at Aspirus Antigo Clinic and a member of Internal Medicine News’ editorial advisory board. These include a 2019 U.S.-based study of more than 167,000 patients with AFib (JAMA Intern Med. 2019;180[2]:245‐253) showing that use of DOACs, particularly apixaban, were linked to lower fracture risk versus warfarin use. Similarly, a Danish national registry study also published in 2019 showed that the absolute risk of osteoporotic fractures was low overall and significantly lower in patients who received DOACs (J Am Coll Cardiol. 2019;74[17]:2150-2158).

Funding for the study came from the University of Hong Kong and University College London Strategic Planning Fund. The study authors reported disclosures related to Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Amgen, Takeda, IQVIA, and others.

SOURCE: Lau WCY et al. Ann Intern Med. 2020 May 18. doi: 10.7326/M19-3671.

Among patients with atrial fibrillation, use of direct oral anticoagulants is linked to lower osteoporotic fracture risk versus warfarin, results of a recent population-based cohort study show.

iStock/Thinkstock

The choice of direct oral anticoagulant (DOAC) didn’t appear to have an impact, as each individual agent yielded a substantially lower risk of fracture versus the vitamin K antagonist, with risk reductions ranging from 38% to 48%, according to the study authors.

This is one of the latest reports to suggest DOACs could have an edge over warfarin for preventing fractures, providing new evidence that “may help inform the benefit risk assessment” when it comes to choosing an anticoagulant for a patient with atrial fibrillation (AFib) in the clinic, wrote the authors, led by Wallis C.Y. Lau, PhD, with the University College London.

“There exists a compelling case for evaluating whether the risk for osteoporotic fractures should be considered at the point of prescribing an oral anticoagulant to minimize fracture risk,” Dr. Lau and coauthors wrote in a report on the study that appears in Annals of Internal Medicine.

The case is especially compelling since fracture risk is “often neglected” when choosing an anticoagulant, the authors wrote. Surgeries to treat fracture are difficult because of the need for perioperative management of anticoagulation as “a balance between the risk for stroke and excessive bleeding must be achieved,” they added.

Based on these data, physicians should strongly consider DOACs as an alternative to vitamin K antagonists to reduce the risk of osteoporosis over the long term in patients with AFib, according to Victor Lawrence Roberts, MD, a Florida endocrinologist.

“Osteoporosis takes years, sometimes decades to develop, and if you then overlay warfarin on top of a readily evolving metabolic bone disease, you probably accelerate that process, said Dr. Roberts, professor of internal medicine at the University of Central Florida, Orlando, and editorial advisory board member of Internal Medicine News.

There’s a considerable amount of concerning preclinical data that warfarin could increase osteoporotic fracture risk. Of note, vitamin K antagonists modulate osteocalcin, a calcium-binding bone matrix protein, Dr. Roberts said.

“Osteocalcin is important for bone metabolism and health, and inhibiting osteocalcin will inhibit the ability to have a healthy bone matrix,” he explained.

The impact of anticoagulants on fracture risk is particularly relevant to patients with AFib, according to Dr. Lau and colleagues, who referenced one 2017 report showing a higher incidence of hip fracture among AFib patients versus those without AFib.

In their more recent study, Dr. Lau and colleagues reviewed electronic health records in a Hong Kong database for 23,515 older adults with a new diagnosis of AFib who received a new prescription of warfarin or DOACs including apixaban, dabigatran, or rivaroxaban.

DOAC use was consistently associated with a lower risk of osteoporotic fractures versus warfarin, regardless of the DOAC considered. The hazard ratios were 0.62 (95% confidence interval, 0.41-0.94) for apixaban, 0.65 (95% CI, 0.49-0.86) for dabigatran, and 0.52 (95% CI, 0.37-0.73) for rivaroxaban versus warfarin, the report showed.

Head-to-head comparisons between DOACS didn’t yield any statistically significant differences, though the analyses were underpowered in this respect, according to the investigators.

“This study can only rule out more than a twofold higher or a 50% lower relative risk for osteoporotic fractures between individual DOACs,” they wrote. “However, any absolute risk differences were small and would likely be of minor clinical significance.”

The reduced risk of fracture for DOACs versus warfarin was consistent in men and women with AFib, suggesting that women may particularly benefit from DOACs, given that they have a higher risk of fracture than men, the investigators added.

The results of this study suggest yet another benefit of DOACs over warfarin in patients with AFib, according to internist Noel Deep, MD, who is the chief medical officer of Aspirus Langlade Hospital in Antigo, Wisconsin.

“The lower risk of osteoporotic fractures with DOACS, in addition to other advantages such as lower risk of intracranial bleeding, once- or twice-daily consistent dosing, no dietary restrictions, and no blood tests to regulate the dose might be another reason that physicians may favor them over warfarin in older individuals requiring anticoagulation,” Dr. Deep said in an interview.

Results of this and several other recent studies may help in recommending DOACs to internal medicine patients who have a diagnosis of AFib requiring anticoagulation, according to Dr. Deep, who is also a physician at Aspirus Antigo Clinic and a member of Internal Medicine News’ editorial advisory board. These include a 2019 U.S.-based study of more than 167,000 patients with AFib (JAMA Intern Med. 2019;180[2]:245‐253) showing that use of DOACs, particularly apixaban, were linked to lower fracture risk versus warfarin use. Similarly, a Danish national registry study also published in 2019 showed that the absolute risk of osteoporotic fractures was low overall and significantly lower in patients who received DOACs (J Am Coll Cardiol. 2019;74[17]:2150-2158).

Funding for the study came from the University of Hong Kong and University College London Strategic Planning Fund. The study authors reported disclosures related to Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Amgen, Takeda, IQVIA, and others.

SOURCE: Lau WCY et al. Ann Intern Med. 2020 May 18. doi: 10.7326/M19-3671.

Among patients with atrial fibrillation, use of direct oral anticoagulants is linked to lower osteoporotic fracture risk versus warfarin, results of a recent population-based cohort study show.

iStock/Thinkstock

The choice of direct oral anticoagulant (DOAC) didn’t appear to have an impact, as each individual agent yielded a substantially lower risk of fracture versus the vitamin K antagonist, with risk reductions ranging from 38% to 48%, according to the study authors.

This is one of the latest reports to suggest DOACs could have an edge over warfarin for preventing fractures, providing new evidence that “may help inform the benefit risk assessment” when it comes to choosing an anticoagulant for a patient with atrial fibrillation (AFib) in the clinic, wrote the authors, led by Wallis C.Y. Lau, PhD, with the University College London.

“There exists a compelling case for evaluating whether the risk for osteoporotic fractures should be considered at the point of prescribing an oral anticoagulant to minimize fracture risk,” Dr. Lau and coauthors wrote in a report on the study that appears in Annals of Internal Medicine.

The case is especially compelling since fracture risk is “often neglected” when choosing an anticoagulant, the authors wrote. Surgeries to treat fracture are difficult because of the need for perioperative management of anticoagulation as “a balance between the risk for stroke and excessive bleeding must be achieved,” they added.

Based on these data, physicians should strongly consider DOACs as an alternative to vitamin K antagonists to reduce the risk of osteoporosis over the long term in patients with AFib, according to Victor Lawrence Roberts, MD, a Florida endocrinologist.

“Osteoporosis takes years, sometimes decades to develop, and if you then overlay warfarin on top of a readily evolving metabolic bone disease, you probably accelerate that process, said Dr. Roberts, professor of internal medicine at the University of Central Florida, Orlando, and editorial advisory board member of Internal Medicine News.

There’s a considerable amount of concerning preclinical data that warfarin could increase osteoporotic fracture risk. Of note, vitamin K antagonists modulate osteocalcin, a calcium-binding bone matrix protein, Dr. Roberts said.

“Osteocalcin is important for bone metabolism and health, and inhibiting osteocalcin will inhibit the ability to have a healthy bone matrix,” he explained.

The impact of anticoagulants on fracture risk is particularly relevant to patients with AFib, according to Dr. Lau and colleagues, who referenced one 2017 report showing a higher incidence of hip fracture among AFib patients versus those without AFib.

In their more recent study, Dr. Lau and colleagues reviewed electronic health records in a Hong Kong database for 23,515 older adults with a new diagnosis of AFib who received a new prescription of warfarin or DOACs including apixaban, dabigatran, or rivaroxaban.

DOAC use was consistently associated with a lower risk of osteoporotic fractures versus warfarin, regardless of the DOAC considered. The hazard ratios were 0.62 (95% confidence interval, 0.41-0.94) for apixaban, 0.65 (95% CI, 0.49-0.86) for dabigatran, and 0.52 (95% CI, 0.37-0.73) for rivaroxaban versus warfarin, the report showed.

Head-to-head comparisons between DOACS didn’t yield any statistically significant differences, though the analyses were underpowered in this respect, according to the investigators.

“This study can only rule out more than a twofold higher or a 50% lower relative risk for osteoporotic fractures between individual DOACs,” they wrote. “However, any absolute risk differences were small and would likely be of minor clinical significance.”

The reduced risk of fracture for DOACs versus warfarin was consistent in men and women with AFib, suggesting that women may particularly benefit from DOACs, given that they have a higher risk of fracture than men, the investigators added.

The results of this study suggest yet another benefit of DOACs over warfarin in patients with AFib, according to internist Noel Deep, MD, who is the chief medical officer of Aspirus Langlade Hospital in Antigo, Wisconsin.

“The lower risk of osteoporotic fractures with DOACS, in addition to other advantages such as lower risk of intracranial bleeding, once- or twice-daily consistent dosing, no dietary restrictions, and no blood tests to regulate the dose might be another reason that physicians may favor them over warfarin in older individuals requiring anticoagulation,” Dr. Deep said in an interview.

Results of this and several other recent studies may help in recommending DOACs to internal medicine patients who have a diagnosis of AFib requiring anticoagulation, according to Dr. Deep, who is also a physician at Aspirus Antigo Clinic and a member of Internal Medicine News’ editorial advisory board. These include a 2019 U.S.-based study of more than 167,000 patients with AFib (JAMA Intern Med. 2019;180[2]:245‐253) showing that use of DOACs, particularly apixaban, were linked to lower fracture risk versus warfarin use. Similarly, a Danish national registry study also published in 2019 showed that the absolute risk of osteoporotic fractures was low overall and significantly lower in patients who received DOACs (J Am Coll Cardiol. 2019;74[17]:2150-2158).

Funding for the study came from the University of Hong Kong and University College London Strategic Planning Fund. The study authors reported disclosures related to Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Amgen, Takeda, IQVIA, and others.

SOURCE: Lau WCY et al. Ann Intern Med. 2020 May 18. doi: 10.7326/M19-3671.

A leadless right-ventricular pacemaker continued to show an edge over conventional transvenous pacemakers by triggering a substantially reduced rate of complications during the 6 months following placement in a review of more than 10,000 Medicare patients treated over 2 years.

The “largest leadless pacemaker cohort to date” showed that in propensity score–matched cohorts, the 3,276 patients who received the Micra leadless transcatheter pacemaker during routine management and were followed for 6 months had a 3.3% rate of total complications, compared with a 9.4% rate among 7,256 patients who received a conventional VVI pacemaker with a transvenous lead, a statistically significant 66% relative risk reduction, Jonathan P. Piccini, MD, said at the annual scientific sessions of the Heart Rhythm Society, held online because of COVID-19.

The 66% reduced rate of complications – both acutely and with further follow-up – was similar to the complication reductions seen with Micra, compared with historical controls who received transvenous single-chamber pacemakers in both the pivotal study for the device (Heart Rhythm. 2017 May 1;14[3]:702-9) and in a postapproval registry study (Heart Rhythm. 2018 Dec 1;15[12]:1800-7). However, the newly reported advantage came in a population that was notably older and had significantly more comorbidities than in the prior leadless pacemaker studies, said Dr. Piccini, a cardiac electrophysiologist at Duke University, Durham, N.C.

The new Medicare data “tell us that physicians are reaching for these devices [leadless pacemakers] in patients with more comorbidities and a higher risk for complications to give them a [device with] better safety profile,” he said during a press briefing. “At Duke, and I suspect at other centers, when a patients is eligible for a leadless pacemaker that’s the preferred option.”

However, Dr. Piccini cited three examples of the small proportion of patients who are appropriate for the type of pacing the leadless pacemaker supplies but would be better candidates for a device with a transvenous lead: patients who failed treatment with a initial leadless pacemaker and have no suitable alternative subcutaneous spot to place the replacement device in a stable way, those with severe right ventricular enlargement that interferes with optimal placement, and those who don’t currently meet criteria for biventricular pacing but appear likely to switch to that pacing mode in the near term.

The 66% relative reduction in complications was “impressive; I hope this will be a message,” commented Nassir F. Marrouche, MD, a cardiac electrophysiologist and professor of medicine at Tulane University, New Orleans. Importantly, this reduced complication rate occurred in a real-world population that was sicker than any patient group previously studied with the device, he noted as a designated discussant for the report.

But the report’s second designated discussant, Roderick Tung, MD, highlighted some caveats when interpreting the lower complication rate with the leadless device compared with historical controls. He cited the absence of any episodes of pneumothorax among the patients reviewed by Dr. Piccini who received a leadless pacemaker, compared with a 5% rate among the control patients who had received a device with a transvenous lead, a major driver of the overall difference in complication rates. This difference “may not be relevant to operators who use either an axillary extrathoracic vein route for lead placement or a cephalic vein approach,” said Dr. Tung, director of cardiac electrophysiology at the University of Chicago. “There should not be a 5% rate of pneumothorax when implanting a VVI device.” The results reported by Dr. Piccini have the advantages of coming from many patients and from real-world practice, he acknowledged, but interpretation is limited by the lack of a randomized control group and the outsized impact of pneumothorax complications on the safety comparison.

The other major component of the 6-month complication tally was device-related events, which were twice as common in the historical controls who received a transvenous lead at a rate of 3.4%. The sole 6-month event more common among the patients who received a leadless pacemaker was pericarditis, at a rate of 1.3% in the Micra group and 0.5% in the transvenous lead controls, Dr. Piccini reported. The 6-month rate of device revisions was 1.7% with the leadless device and 2.8% with transvenous lead pacemakers, a difference that was not statistically significant. The two treatment arms had virtually identical 6-month mortality rates.

The rate of acute complications during the first 30 days after implant was also virtually the same in the two study arms. Patient who received the leadless device had significantly more puncture-site events, at a rate of 1.2%, and significantly more cardiac effusions or perforations, at a rate of 0.8%. The historical control patients who received devices with transvenous leads had significantly more device-related complications after 30 days, a 2.5% rate.

The 30-day cohorts examined had larger numbers of patients than at 6 months, 5,746 leadless pacemaker recipients and 9,662 matched historical controls who had received a transvenous lead pacemaker. The clinical and demographic profile of the 30-day cohort who received the leadless pacemaker highlighted the sicker nature of these patients compared with earlier studies of the device. They were an average age of 79 years, compared with average ages of 76 years in the two prior Micra studies, and they also had double the prevalence of coronary disease, triple the prevalence of heart failure, more than twice the rate of chronic obstructive pulmonary disease, and almost twice the prevalence of diabetes.

During the period examined in this report from Micra CED (Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers), in 2017-2018, the leadless pacemaker’s initial approved indications were for a circumscribed portion of the overall patient population that needs pacing. Essentially, they were elderly patients with persistent atrial fibrillation who only need ventricular pacing, roughly 15% of the overall cohort of pacing candidates. In January 2020, the FDA added an indication for high-grade atrioventricular block, an expanded population of candidates that roughly tripled the number of potentially appropriate recipients, said Larry A. Chinitz, MD, a cardiac electrophysiologist and a coinvestigator on some of the studies that led to the new indication, in an interview at the time of the revised labeling.

The study was sponsored by Medtronic, which markets the Micra leadless pacemaker. Dr. Piccini has received honoraria from Medtronic and several other companies. Dr. Marrouche has been a consultant to Medtronic as well as to Biosense Webster, Biotronik, Cardiac Design, and Preventice, and has received research funding from Abbott, Biosense Webster, Boston Scientific, and GE Healthcare. Dr. Tung has been a speaker on behalf of Abbott, Boston Scientific, and Biosense Webster. Dr. Chinitz has received fees and fellowship support from Medtronic, and has also received fees from Abbott, Biosense Webster, Biotronik, and Pfizer.

[email protected]

SOURCE: Piccini JP et al. Heart Rhythm 2020, Abstract D-LBCT04-01.

A leadless right-ventricular pacemaker continued to show an edge over conventional transvenous pacemakers by triggering a substantially reduced rate of complications during the 6 months following placement in a review of more than 10,000 Medicare patients treated over 2 years.

The “largest leadless pacemaker cohort to date” showed that in propensity score–matched cohorts, the 3,276 patients who received the Micra leadless transcatheter pacemaker during routine management and were followed for 6 months had a 3.3% rate of total complications, compared with a 9.4% rate among 7,256 patients who received a conventional VVI pacemaker with a transvenous lead, a statistically significant 66% relative risk reduction, Jonathan P. Piccini, MD, said at the annual scientific sessions of the Heart Rhythm Society, held online because of COVID-19.

The 66% reduced rate of complications – both acutely and with further follow-up – was similar to the complication reductions seen with Micra, compared with historical controls who received transvenous single-chamber pacemakers in both the pivotal study for the device (Heart Rhythm. 2017 May 1;14[3]:702-9) and in a postapproval registry study (Heart Rhythm. 2018 Dec 1;15[12]:1800-7). However, the newly reported advantage came in a population that was notably older and had significantly more comorbidities than in the prior leadless pacemaker studies, said Dr. Piccini, a cardiac electrophysiologist at Duke University, Durham, N.C.

The new Medicare data “tell us that physicians are reaching for these devices [leadless pacemakers] in patients with more comorbidities and a higher risk for complications to give them a [device with] better safety profile,” he said during a press briefing. “At Duke, and I suspect at other centers, when a patients is eligible for a leadless pacemaker that’s the preferred option.”

However, Dr. Piccini cited three examples of the small proportion of patients who are appropriate for the type of pacing the leadless pacemaker supplies but would be better candidates for a device with a transvenous lead: patients who failed treatment with a initial leadless pacemaker and have no suitable alternative subcutaneous spot to place the replacement device in a stable way, those with severe right ventricular enlargement that interferes with optimal placement, and those who don’t currently meet criteria for biventricular pacing but appear likely to switch to that pacing mode in the near term.

The 66% relative reduction in complications was “impressive; I hope this will be a message,” commented Nassir F. Marrouche, MD, a cardiac electrophysiologist and professor of medicine at Tulane University, New Orleans. Importantly, this reduced complication rate occurred in a real-world population that was sicker than any patient group previously studied with the device, he noted as a designated discussant for the report.

But the report’s second designated discussant, Roderick Tung, MD, highlighted some caveats when interpreting the lower complication rate with the leadless device compared with historical controls. He cited the absence of any episodes of pneumothorax among the patients reviewed by Dr. Piccini who received a leadless pacemaker, compared with a 5% rate among the control patients who had received a device with a transvenous lead, a major driver of the overall difference in complication rates. This difference “may not be relevant to operators who use either an axillary extrathoracic vein route for lead placement or a cephalic vein approach,” said Dr. Tung, director of cardiac electrophysiology at the University of Chicago. “There should not be a 5% rate of pneumothorax when implanting a VVI device.” The results reported by Dr. Piccini have the advantages of coming from many patients and from real-world practice, he acknowledged, but interpretation is limited by the lack of a randomized control group and the outsized impact of pneumothorax complications on the safety comparison.

The other major component of the 6-month complication tally was device-related events, which were twice as common in the historical controls who received a transvenous lead at a rate of 3.4%. The sole 6-month event more common among the patients who received a leadless pacemaker was pericarditis, at a rate of 1.3% in the Micra group and 0.5% in the transvenous lead controls, Dr. Piccini reported. The 6-month rate of device revisions was 1.7% with the leadless device and 2.8% with transvenous lead pacemakers, a difference that was not statistically significant. The two treatment arms had virtually identical 6-month mortality rates.

The rate of acute complications during the first 30 days after implant was also virtually the same in the two study arms. Patient who received the leadless device had significantly more puncture-site events, at a rate of 1.2%, and significantly more cardiac effusions or perforations, at a rate of 0.8%. The historical control patients who received devices with transvenous leads had significantly more device-related complications after 30 days, a 2.5% rate.

The 30-day cohorts examined had larger numbers of patients than at 6 months, 5,746 leadless pacemaker recipients and 9,662 matched historical controls who had received a transvenous lead pacemaker. The clinical and demographic profile of the 30-day cohort who received the leadless pacemaker highlighted the sicker nature of these patients compared with earlier studies of the device. They were an average age of 79 years, compared with average ages of 76 years in the two prior Micra studies, and they also had double the prevalence of coronary disease, triple the prevalence of heart failure, more than twice the rate of chronic obstructive pulmonary disease, and almost twice the prevalence of diabetes.

During the period examined in this report from Micra CED (Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers), in 2017-2018, the leadless pacemaker’s initial approved indications were for a circumscribed portion of the overall patient population that needs pacing. Essentially, they were elderly patients with persistent atrial fibrillation who only need ventricular pacing, roughly 15% of the overall cohort of pacing candidates. In January 2020, the FDA added an indication for high-grade atrioventricular block, an expanded population of candidates that roughly tripled the number of potentially appropriate recipients, said Larry A. Chinitz, MD, a cardiac electrophysiologist and a coinvestigator on some of the studies that led to the new indication, in an interview at the time of the revised labeling.

The study was sponsored by Medtronic, which markets the Micra leadless pacemaker. Dr. Piccini has received honoraria from Medtronic and several other companies. Dr. Marrouche has been a consultant to Medtronic as well as to Biosense Webster, Biotronik, Cardiac Design, and Preventice, and has received research funding from Abbott, Biosense Webster, Boston Scientific, and GE Healthcare. Dr. Tung has been a speaker on behalf of Abbott, Boston Scientific, and Biosense Webster. Dr. Chinitz has received fees and fellowship support from Medtronic, and has also received fees from Abbott, Biosense Webster, Biotronik, and Pfizer.

[email protected]

SOURCE: Piccini JP et al. Heart Rhythm 2020, Abstract D-LBCT04-01.

A leadless right-ventricular pacemaker continued to show an edge over conventional transvenous pacemakers by triggering a substantially reduced rate of complications during the 6 months following placement in a review of more than 10,000 Medicare patients treated over 2 years.

The “largest leadless pacemaker cohort to date” showed that in propensity score–matched cohorts, the 3,276 patients who received the Micra leadless transcatheter pacemaker during routine management and were followed for 6 months had a 3.3% rate of total complications, compared with a 9.4% rate among 7,256 patients who received a conventional VVI pacemaker with a transvenous lead, a statistically significant 66% relative risk reduction, Jonathan P. Piccini, MD, said at the annual scientific sessions of the Heart Rhythm Society, held online because of COVID-19.

The 66% reduced rate of complications – both acutely and with further follow-up – was similar to the complication reductions seen with Micra, compared with historical controls who received transvenous single-chamber pacemakers in both the pivotal study for the device (Heart Rhythm. 2017 May 1;14[3]:702-9) and in a postapproval registry study (Heart Rhythm. 2018 Dec 1;15[12]:1800-7). However, the newly reported advantage came in a population that was notably older and had significantly more comorbidities than in the prior leadless pacemaker studies, said Dr. Piccini, a cardiac electrophysiologist at Duke University, Durham, N.C.

The new Medicare data “tell us that physicians are reaching for these devices [leadless pacemakers] in patients with more comorbidities and a higher risk for complications to give them a [device with] better safety profile,” he said during a press briefing. “At Duke, and I suspect at other centers, when a patients is eligible for a leadless pacemaker that’s the preferred option.”

However, Dr. Piccini cited three examples of the small proportion of patients who are appropriate for the type of pacing the leadless pacemaker supplies but would be better candidates for a device with a transvenous lead: patients who failed treatment with a initial leadless pacemaker and have no suitable alternative subcutaneous spot to place the replacement device in a stable way, those with severe right ventricular enlargement that interferes with optimal placement, and those who don’t currently meet criteria for biventricular pacing but appear likely to switch to that pacing mode in the near term.

The 66% relative reduction in complications was “impressive; I hope this will be a message,” commented Nassir F. Marrouche, MD, a cardiac electrophysiologist and professor of medicine at Tulane University, New Orleans. Importantly, this reduced complication rate occurred in a real-world population that was sicker than any patient group previously studied with the device, he noted as a designated discussant for the report.

But the report’s second designated discussant, Roderick Tung, MD, highlighted some caveats when interpreting the lower complication rate with the leadless device compared with historical controls. He cited the absence of any episodes of pneumothorax among the patients reviewed by Dr. Piccini who received a leadless pacemaker, compared with a 5% rate among the control patients who had received a device with a transvenous lead, a major driver of the overall difference in complication rates. This difference “may not be relevant to operators who use either an axillary extrathoracic vein route for lead placement or a cephalic vein approach,” said Dr. Tung, director of cardiac electrophysiology at the University of Chicago. “There should not be a 5% rate of pneumothorax when implanting a VVI device.” The results reported by Dr. Piccini have the advantages of coming from many patients and from real-world practice, he acknowledged, but interpretation is limited by the lack of a randomized control group and the outsized impact of pneumothorax complications on the safety comparison.

The other major component of the 6-month complication tally was device-related events, which were twice as common in the historical controls who received a transvenous lead at a rate of 3.4%. The sole 6-month event more common among the patients who received a leadless pacemaker was pericarditis, at a rate of 1.3% in the Micra group and 0.5% in the transvenous lead controls, Dr. Piccini reported. The 6-month rate of device revisions was 1.7% with the leadless device and 2.8% with transvenous lead pacemakers, a difference that was not statistically significant. The two treatment arms had virtually identical 6-month mortality rates.

The rate of acute complications during the first 30 days after implant was also virtually the same in the two study arms. Patient who received the leadless device had significantly more puncture-site events, at a rate of 1.2%, and significantly more cardiac effusions or perforations, at a rate of 0.8%. The historical control patients who received devices with transvenous leads had significantly more device-related complications after 30 days, a 2.5% rate.

The 30-day cohorts examined had larger numbers of patients than at 6 months, 5,746 leadless pacemaker recipients and 9,662 matched historical controls who had received a transvenous lead pacemaker. The clinical and demographic profile of the 30-day cohort who received the leadless pacemaker highlighted the sicker nature of these patients compared with earlier studies of the device. They were an average age of 79 years, compared with average ages of 76 years in the two prior Micra studies, and they also had double the prevalence of coronary disease, triple the prevalence of heart failure, more than twice the rate of chronic obstructive pulmonary disease, and almost twice the prevalence of diabetes.

During the period examined in this report from Micra CED (Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers), in 2017-2018, the leadless pacemaker’s initial approved indications were for a circumscribed portion of the overall patient population that needs pacing. Essentially, they were elderly patients with persistent atrial fibrillation who only need ventricular pacing, roughly 15% of the overall cohort of pacing candidates. In January 2020, the FDA added an indication for high-grade atrioventricular block, an expanded population of candidates that roughly tripled the number of potentially appropriate recipients, said Larry A. Chinitz, MD, a cardiac electrophysiologist and a coinvestigator on some of the studies that led to the new indication, in an interview at the time of the revised labeling.

The study was sponsored by Medtronic, which markets the Micra leadless pacemaker. Dr. Piccini has received honoraria from Medtronic and several other companies. Dr. Marrouche has been a consultant to Medtronic as well as to Biosense Webster, Biotronik, Cardiac Design, and Preventice, and has received research funding from Abbott, Biosense Webster, Boston Scientific, and GE Healthcare. Dr. Tung has been a speaker on behalf of Abbott, Boston Scientific, and Biosense Webster. Dr. Chinitz has received fees and fellowship support from Medtronic, and has also received fees from Abbott, Biosense Webster, Biotronik, and Pfizer.

[email protected]

SOURCE: Piccini JP et al. Heart Rhythm 2020, Abstract D-LBCT04-01.

It is time to broaden the definition of osteoporosis used in clinical guidelines, states an article published in Age and Ageing, the official journal of the British Geriatrics Society.

The authors recommend that the World Health Organization and the International Society for Clinical Densitometry consider a broader definition of osteoporosis, which encompasses clinical diagnosis, providing clear guidance on communicating bone mineral density (BMD) results to patients.

The WHO definition of osteoporosis, which is endorsed as a diagnostic threshold in current U.K. and European guidance, still relies purely on BMD testing (T score of −2.5 SD or more). The authors say this definition no longer relates to the population for whom osteoporosis drugs are recommended.

In the past 15 years, they write, there has been a change in the field of osteoporosis, namely to base osteoporosis management not just on absolute values of BMD but also on broader consideration of future fracture risk. This change has been underpinned by observations that the majority of patients with a fragility fracture do not have osteoporotic BMD.

Coauthor Zoe Paskins, MBChB, a senior lecturer at Keele (England) University and clinical lead for the osteoporosis service in North Staffordshire, argues that many people with osteoporosis do not receive the treatment they need because of inconsistencies in how the condition is diagnosed around the world, resulting in confusion for both clinicians and patients.

“We think it is time for the WHO to reconsider the definition of osteoporosis, which is now more than 25 years old. A new definition is needed to acknowledge that it is possible, in some circumstances, to give a clinical diagnosis of osteoporosis in those who have osteoporotic fractures. In our view, this would help address current confusion and improve uptake of treatments,” she said.

This article first appeared on Univadis.

It is time to broaden the definition of osteoporosis used in clinical guidelines, states an article published in Age and Ageing, the official journal of the British Geriatrics Society.

The authors recommend that the World Health Organization and the International Society for Clinical Densitometry consider a broader definition of osteoporosis, which encompasses clinical diagnosis, providing clear guidance on communicating bone mineral density (BMD) results to patients.

The WHO definition of osteoporosis, which is endorsed as a diagnostic threshold in current U.K. and European guidance, still relies purely on BMD testing (T score of −2.5 SD or more). The authors say this definition no longer relates to the population for whom osteoporosis drugs are recommended.

In the past 15 years, they write, there has been a change in the field of osteoporosis, namely to base osteoporosis management not just on absolute values of BMD but also on broader consideration of future fracture risk. This change has been underpinned by observations that the majority of patients with a fragility fracture do not have osteoporotic BMD.

Coauthor Zoe Paskins, MBChB, a senior lecturer at Keele (England) University and clinical lead for the osteoporosis service in North Staffordshire, argues that many people with osteoporosis do not receive the treatment they need because of inconsistencies in how the condition is diagnosed around the world, resulting in confusion for both clinicians and patients.

“We think it is time for the WHO to reconsider the definition of osteoporosis, which is now more than 25 years old. A new definition is needed to acknowledge that it is possible, in some circumstances, to give a clinical diagnosis of osteoporosis in those who have osteoporotic fractures. In our view, this would help address current confusion and improve uptake of treatments,” she said.

This article first appeared on Univadis.

It is time to broaden the definition of osteoporosis used in clinical guidelines, states an article published in Age and Ageing, the official journal of the British Geriatrics Society.

The authors recommend that the World Health Organization and the International Society for Clinical Densitometry consider a broader definition of osteoporosis, which encompasses clinical diagnosis, providing clear guidance on communicating bone mineral density (BMD) results to patients.

The WHO definition of osteoporosis, which is endorsed as a diagnostic threshold in current U.K. and European guidance, still relies purely on BMD testing (T score of −2.5 SD or more). The authors say this definition no longer relates to the population for whom osteoporosis drugs are recommended.

In the past 15 years, they write, there has been a change in the field of osteoporosis, namely to base osteoporosis management not just on absolute values of BMD but also on broader consideration of future fracture risk. This change has been underpinned by observations that the majority of patients with a fragility fracture do not have osteoporotic BMD.

Coauthor Zoe Paskins, MBChB, a senior lecturer at Keele (England) University and clinical lead for the osteoporosis service in North Staffordshire, argues that many people with osteoporosis do not receive the treatment they need because of inconsistencies in how the condition is diagnosed around the world, resulting in confusion for both clinicians and patients.

“We think it is time for the WHO to reconsider the definition of osteoporosis, which is now more than 25 years old. A new definition is needed to acknowledge that it is possible, in some circumstances, to give a clinical diagnosis of osteoporosis in those who have osteoporotic fractures. In our view, this would help address current confusion and improve uptake of treatments,” she said.

This article first appeared on Univadis.

A high-intensity exercise program, already shown effective in improving bone density and performance in women, is also effective in older men with low bone density, according to the LIFTMOR-M study, published in Bone. The protocol incorporates barbell-based weightlifting and impact training involving jumping chin-ups.

sbm Hotting/Fotolia.com

“When you’ve got a condition primarily in one of the sexes, the other sex often gets ignored, and that’s absolute the case with osteoporosis,” said lead author Belinda Beck, PhD, a professor at Griffith University, Gold Coast, Australia, in an interview.

In older adults with low bone density, when it comes to building bone and reducing fracture, a review of the literature suggests that exercise doesn’t work. That’s not really true though, according to Dr. Beck. An unpublished analysis of studies of high-intensity exercise only at her institution shows promise. “It looks like exercise doesn’t work. It’s not that, it’s that the wrong kind of exercise doesn’t work,” she stressed.

The original LIFTMOR trial, in women, was inspired by a collaboration with Lisa Weis, an Olympic weightlifter who specialized in training older women, who subsequently showed improvements on bone scans. “That’s what jump-started it, because just like every other scientist, I would have been too scared to do this kind of loading in this fragile population, and that’s the reason why people haven’t been doing it. They don’t want to break people,” said Dr. Beck.

The investigators “cherry-picked some of those exercises and tested them in the LIFTMOR trial. I was nervous about the study because the weights we were lifting were much heavier than most people had applied for people with osteoporosis. The risk was, we would cause the fractures we were trying to prevent,” said Dr. Beck. Her team tested a high-intensity resistance and impact (HiRIT) protocol in postmenopausal women with low bone mass (J Bone Miner Res. 2019 Mar;34[3]:572. Controls underwent a home-based, low-intensity exercise program. They found improvements in bone density and functional performance, compared with controls.

“The exercise was effective and safe for this population if practiced with proper technique under close supervision,” said Dr. Beck, but she emphasized that the exercises must be led by experienced coaches because of the potential for injury.

The investigators then looked at men. “There are still one in five men over 50 who are going to fracture,” Dr. Beck said.

Her team launched LIFTMOR-M, which enrolled 93 men (mean age, 67.1 years) with a lower than average proximal femur areal bone mineral density. Of them, 34 were randomized to HiRIT, 33 to supervised machine-based isometric axial compression (IAC) exercise training, and 26 were designated as controls and self-selected to usual activities.

The intervention included 8 months of twice-weekly, supervised, 30-minute HiRIT sessions, which included five sets of five repetitions, using more than 85% the weight of the single repetition maximum. The routine included the deadlift, squat, and overhead press. The impact component included five sets of five repetitions of jumping chin-ups followed by a firm, flat-footed landing.

After 8 months, there was no difference in compliance between the two intervention groups. Those in the HiRIT group had improved medial femoral neck cortical thickness, compared with controls (5.6% vs. –0.1%; P = .028) and IAC (5.6% vs. 0.7%; P = .044). Those in the HiRIT group maintained distal tibia trabecular area, while the control group experienced a loss (0.2% vs. –1.6%; P = .013). The IAC group did not show any improvement in bone strength in any of the sites examined, though some findings suggest it may counteract age-related loss in bone strength indices in the distal tibia and radius.

The program requires a fluid movement that maintains a neutral spine throughout. Dr. Beck has developed the Onero program (theboneclinic.com.au/onero/) based on the routine, and licenses it to physical therapists and exercise physiologists.

The study was funded by the Australian Research Foundation and the Australian Government Research Training Program. Dr. Beck owns the Bone Clinic, which sells licenses to the Onero program based on the exercise program used in the study.

SOURCE: Beck B et al. Bone. 2020 April 11. doi: 10.1016/j.bone.2020.115362.

A high-intensity exercise program, already shown effective in improving bone density and performance in women, is also effective in older men with low bone density, according to the LIFTMOR-M study, published in Bone. The protocol incorporates barbell-based weightlifting and impact training involving jumping chin-ups.

sbm Hotting/Fotolia.com

“When you’ve got a condition primarily in one of the sexes, the other sex often gets ignored, and that’s absolute the case with osteoporosis,” said lead author Belinda Beck, PhD, a professor at Griffith University, Gold Coast, Australia, in an interview.

In older adults with low bone density, when it comes to building bone and reducing fracture, a review of the literature suggests that exercise doesn’t work. That’s not really true though, according to Dr. Beck. An unpublished analysis of studies of high-intensity exercise only at her institution shows promise. “It looks like exercise doesn’t work. It’s not that, it’s that the wrong kind of exercise doesn’t work,” she stressed.

The original LIFTMOR trial, in women, was inspired by a collaboration with Lisa Weis, an Olympic weightlifter who specialized in training older women, who subsequently showed improvements on bone scans. “That’s what jump-started it, because just like every other scientist, I would have been too scared to do this kind of loading in this fragile population, and that’s the reason why people haven’t been doing it. They don’t want to break people,” said Dr. Beck.

The investigators “cherry-picked some of those exercises and tested them in the LIFTMOR trial. I was nervous about the study because the weights we were lifting were much heavier than most people had applied for people with osteoporosis. The risk was, we would cause the fractures we were trying to prevent,” said Dr. Beck. Her team tested a high-intensity resistance and impact (HiRIT) protocol in postmenopausal women with low bone mass (J Bone Miner Res. 2019 Mar;34[3]:572. Controls underwent a home-based, low-intensity exercise program. They found improvements in bone density and functional performance, compared with controls.

“The exercise was effective and safe for this population if practiced with proper technique under close supervision,” said Dr. Beck, but she emphasized that the exercises must be led by experienced coaches because of the potential for injury.

The investigators then looked at men. “There are still one in five men over 50 who are going to fracture,” Dr. Beck said.

Her team launched LIFTMOR-M, which enrolled 93 men (mean age, 67.1 years) with a lower than average proximal femur areal bone mineral density. Of them, 34 were randomized to HiRIT, 33 to supervised machine-based isometric axial compression (IAC) exercise training, and 26 were designated as controls and self-selected to usual activities.

The intervention included 8 months of twice-weekly, supervised, 30-minute HiRIT sessions, which included five sets of five repetitions, using more than 85% the weight of the single repetition maximum. The routine included the deadlift, squat, and overhead press. The impact component included five sets of five repetitions of jumping chin-ups followed by a firm, flat-footed landing.

After 8 months, there was no difference in compliance between the two intervention groups. Those in the HiRIT group had improved medial femoral neck cortical thickness, compared with controls (5.6% vs. –0.1%; P = .028) and IAC (5.6% vs. 0.7%; P = .044). Those in the HiRIT group maintained distal tibia trabecular area, while the control group experienced a loss (0.2% vs. –1.6%; P = .013). The IAC group did not show any improvement in bone strength in any of the sites examined, though some findings suggest it may counteract age-related loss in bone strength indices in the distal tibia and radius.

The program requires a fluid movement that maintains a neutral spine throughout. Dr. Beck has developed the Onero program (theboneclinic.com.au/onero/) based on the routine, and licenses it to physical therapists and exercise physiologists.

The study was funded by the Australian Research Foundation and the Australian Government Research Training Program. Dr. Beck owns the Bone Clinic, which sells licenses to the Onero program based on the exercise program used in the study.

SOURCE: Beck B et al. Bone. 2020 April 11. doi: 10.1016/j.bone.2020.115362.

A high-intensity exercise program, already shown effective in improving bone density and performance in women, is also effective in older men with low bone density, according to the LIFTMOR-M study, published in Bone. The protocol incorporates barbell-based weightlifting and impact training involving jumping chin-ups.

sbm Hotting/Fotolia.com

“When you’ve got a condition primarily in one of the sexes, the other sex often gets ignored, and that’s absolute the case with osteoporosis,” said lead author Belinda Beck, PhD, a professor at Griffith University, Gold Coast, Australia, in an interview.

In older adults with low bone density, when it comes to building bone and reducing fracture, a review of the literature suggests that exercise doesn’t work. That’s not really true though, according to Dr. Beck. An unpublished analysis of studies of high-intensity exercise only at her institution shows promise. “It looks like exercise doesn’t work. It’s not that, it’s that the wrong kind of exercise doesn’t work,” she stressed.

The original LIFTMOR trial, in women, was inspired by a collaboration with Lisa Weis, an Olympic weightlifter who specialized in training older women, who subsequently showed improvements on bone scans. “That’s what jump-started it, because just like every other scientist, I would have been too scared to do this kind of loading in this fragile population, and that’s the reason why people haven’t been doing it. They don’t want to break people,” said Dr. Beck.

The investigators “cherry-picked some of those exercises and tested them in the LIFTMOR trial. I was nervous about the study because the weights we were lifting were much heavier than most people had applied for people with osteoporosis. The risk was, we would cause the fractures we were trying to prevent,” said Dr. Beck. Her team tested a high-intensity resistance and impact (HiRIT) protocol in postmenopausal women with low bone mass (J Bone Miner Res. 2019 Mar;34[3]:572. Controls underwent a home-based, low-intensity exercise program. They found improvements in bone density and functional performance, compared with controls.

“The exercise was effective and safe for this population if practiced with proper technique under close supervision,” said Dr. Beck, but she emphasized that the exercises must be led by experienced coaches because of the potential for injury.

The investigators then looked at men. “There are still one in five men over 50 who are going to fracture,” Dr. Beck said.

Her team launched LIFTMOR-M, which enrolled 93 men (mean age, 67.1 years) with a lower than average proximal femur areal bone mineral density. Of them, 34 were randomized to HiRIT, 33 to supervised machine-based isometric axial compression (IAC) exercise training, and 26 were designated as controls and self-selected to usual activities.

The intervention included 8 months of twice-weekly, supervised, 30-minute HiRIT sessions, which included five sets of five repetitions, using more than 85% the weight of the single repetition maximum. The routine included the deadlift, squat, and overhead press. The impact component included five sets of five repetitions of jumping chin-ups followed by a firm, flat-footed landing.

After 8 months, there was no difference in compliance between the two intervention groups. Those in the HiRIT group had improved medial femoral neck cortical thickness, compared with controls (5.6% vs. –0.1%; P = .028) and IAC (5.6% vs. 0.7%; P = .044). Those in the HiRIT group maintained distal tibia trabecular area, while the control group experienced a loss (0.2% vs. –1.6%; P = .013). The IAC group did not show any improvement in bone strength in any of the sites examined, though some findings suggest it may counteract age-related loss in bone strength indices in the distal tibia and radius.

The program requires a fluid movement that maintains a neutral spine throughout. Dr. Beck has developed the Onero program (theboneclinic.com.au/onero/) based on the routine, and licenses it to physical therapists and exercise physiologists.

The study was funded by the Australian Research Foundation and the Australian Government Research Training Program. Dr. Beck owns the Bone Clinic, which sells licenses to the Onero program based on the exercise program used in the study.

SOURCE: Beck B et al. Bone. 2020 April 11. doi: 10.1016/j.bone.2020.115362.