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Protecting your practice data
While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.
You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.
In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.
A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.
Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.
Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.
Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.
Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.
In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.
Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.
It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.
Backing up data
I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.
Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.
The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.
The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.
You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.
In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.
A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.
Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.
Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.
Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.
Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.
In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.
Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.
It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.
Backing up data
I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.
Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.
The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.
The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.
You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.
In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.
A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.
Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.
Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.
Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.
Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.
In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.
Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.
It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.
Backing up data
I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.
Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.
The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.
The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
Support for minimally invasive mitral valve repair: Mini Mitral published
The trial, which was first presented earlier this year at the American College of Cardiology meeting, showed that minimally invasive mitral valve repair does not improve physical function at 12 weeks, compared with sternotomy, but outcomes at 1 year show minimally invasive repair is as safe and effective as sternotomy for degenerative mitral regurgitation.
The full results are now published online in JAMA.
The authors, led by Enoch Akowuah, MD, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom, explain that mitral valve repair surgery is the preferred treatment for patients with degenerative mitral regurgitation and is routinely performed via full sternotomy, enabling easy access to the heart, flexibility in myocardial protection strategies, and multiple ways of accessing the mitral valve and easing de-airing to prevent air emboli, which cause cerebrovascular accidents.
However, the invasiveness of sternotomy is associated with delayed return to presurgery physical function levels and an increase in postoperative complications.
An alternative new video-guided minimally invasive approach involving a 4- to 7-cm lateral thoracotomy, completely avoiding sternotomy, has been developed, with the hope that it should speed physical recovery function after surgery and reduce postoperative complications and costs by reducing hospital stay.
Dr. Akowuah et al. note that uptake of minithoracotomy is variable, with low rates in the United States and the United Kingdom but high rates in Germany. They say that this variation is attributable to the absence of high-quality evidence from randomized trials demonstrating equivalent or superior benefits, compared with sternotomy, and there are also concerns that the increased technical complexity of minithoracotomy may impair the ability to repair complex valve lesions or increase perioperative complications, particularly vascular injuries and stroke.
The U.K. Mini Mitral trial was therefore conducted to compare the effectiveness and safety of minithoracotomy versus sternotomy mitral valve repair.
For the trial, 330 patients with degenerative mitral regurgitation were randomized to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.
The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) physical functioning scale 12 weeks after the surgery.
This failed to show superiority of minithoracotomy, with a mean difference of 0.68 (95% confidence interval, −1.89 to 3.26) between the two groups.
Analysis of secondary outcomes demonstrated that time spent undertaking moderate to vigorous physical activity was higher among participants receiving minithoracotomy at 6 weeks, although the treatment effect was small at an average of 9 minutes and was not different at 12 weeks.
Postoperative length of hospital stay was reduced after minithoracotomy by 1 day, with a median of 5 days, compared with 6 days after sternotomy.
Although repair techniques were at the discretion of the surgeons and differed between the two procedures, high rates of valve repair and low rates of recurrent mitral regurgitation were observed in both groups. Cardiopulmonary bypass times were longer with minithoracotomy, but postoperative complications and adverse events were similar.
There was no difference between the two groups with respect to the prespecified safety outcome of death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year, which occurred in 5.4% of patients undergoing minithoracotomy and 6.1% of those undergoing sternotomy.
“These findings can inform shared decision-making and treatment guidelines,” the authors conclude.
Approach ‘may appeal to patients’
In an editorial accompanying the publication of the study in JAMA, Maurice Enriquez-Sarano, MD, Minneapolis Heart Institute, Minnesota, says the results should be integrated into patient management.
“Mini-thoracotomy mitral repair carried low risk and was highly effective compared with sternotomy. It can thus be applied successfully by surgeons who achieve the necessary expertise,” he notes.
“Mini-thoracotomy may appeal to patients because the procedure is less disfiguring than sternotomy. The early (6-week) benefit, albeit small and transient, is important to patients,” he adds.
The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reports no relevant financial relationships with industry. Dr. Enriquez-Sarano reports receiving consulting fees from Edwards Lifesciences, Artivion, ChemImage, HighLife, and Corcym.
A version of this article first appeared on Medscape.com.
The trial, which was first presented earlier this year at the American College of Cardiology meeting, showed that minimally invasive mitral valve repair does not improve physical function at 12 weeks, compared with sternotomy, but outcomes at 1 year show minimally invasive repair is as safe and effective as sternotomy for degenerative mitral regurgitation.
The full results are now published online in JAMA.
The authors, led by Enoch Akowuah, MD, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom, explain that mitral valve repair surgery is the preferred treatment for patients with degenerative mitral regurgitation and is routinely performed via full sternotomy, enabling easy access to the heart, flexibility in myocardial protection strategies, and multiple ways of accessing the mitral valve and easing de-airing to prevent air emboli, which cause cerebrovascular accidents.
However, the invasiveness of sternotomy is associated with delayed return to presurgery physical function levels and an increase in postoperative complications.
An alternative new video-guided minimally invasive approach involving a 4- to 7-cm lateral thoracotomy, completely avoiding sternotomy, has been developed, with the hope that it should speed physical recovery function after surgery and reduce postoperative complications and costs by reducing hospital stay.
Dr. Akowuah et al. note that uptake of minithoracotomy is variable, with low rates in the United States and the United Kingdom but high rates in Germany. They say that this variation is attributable to the absence of high-quality evidence from randomized trials demonstrating equivalent or superior benefits, compared with sternotomy, and there are also concerns that the increased technical complexity of minithoracotomy may impair the ability to repair complex valve lesions or increase perioperative complications, particularly vascular injuries and stroke.
The U.K. Mini Mitral trial was therefore conducted to compare the effectiveness and safety of minithoracotomy versus sternotomy mitral valve repair.
For the trial, 330 patients with degenerative mitral regurgitation were randomized to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.
The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) physical functioning scale 12 weeks after the surgery.
This failed to show superiority of minithoracotomy, with a mean difference of 0.68 (95% confidence interval, −1.89 to 3.26) between the two groups.
Analysis of secondary outcomes demonstrated that time spent undertaking moderate to vigorous physical activity was higher among participants receiving minithoracotomy at 6 weeks, although the treatment effect was small at an average of 9 minutes and was not different at 12 weeks.
Postoperative length of hospital stay was reduced after minithoracotomy by 1 day, with a median of 5 days, compared with 6 days after sternotomy.
Although repair techniques were at the discretion of the surgeons and differed between the two procedures, high rates of valve repair and low rates of recurrent mitral regurgitation were observed in both groups. Cardiopulmonary bypass times were longer with minithoracotomy, but postoperative complications and adverse events were similar.
There was no difference between the two groups with respect to the prespecified safety outcome of death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year, which occurred in 5.4% of patients undergoing minithoracotomy and 6.1% of those undergoing sternotomy.
“These findings can inform shared decision-making and treatment guidelines,” the authors conclude.
Approach ‘may appeal to patients’
In an editorial accompanying the publication of the study in JAMA, Maurice Enriquez-Sarano, MD, Minneapolis Heart Institute, Minnesota, says the results should be integrated into patient management.
“Mini-thoracotomy mitral repair carried low risk and was highly effective compared with sternotomy. It can thus be applied successfully by surgeons who achieve the necessary expertise,” he notes.
“Mini-thoracotomy may appeal to patients because the procedure is less disfiguring than sternotomy. The early (6-week) benefit, albeit small and transient, is important to patients,” he adds.
The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reports no relevant financial relationships with industry. Dr. Enriquez-Sarano reports receiving consulting fees from Edwards Lifesciences, Artivion, ChemImage, HighLife, and Corcym.
A version of this article first appeared on Medscape.com.
The trial, which was first presented earlier this year at the American College of Cardiology meeting, showed that minimally invasive mitral valve repair does not improve physical function at 12 weeks, compared with sternotomy, but outcomes at 1 year show minimally invasive repair is as safe and effective as sternotomy for degenerative mitral regurgitation.
The full results are now published online in JAMA.
The authors, led by Enoch Akowuah, MD, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom, explain that mitral valve repair surgery is the preferred treatment for patients with degenerative mitral regurgitation and is routinely performed via full sternotomy, enabling easy access to the heart, flexibility in myocardial protection strategies, and multiple ways of accessing the mitral valve and easing de-airing to prevent air emboli, which cause cerebrovascular accidents.
However, the invasiveness of sternotomy is associated with delayed return to presurgery physical function levels and an increase in postoperative complications.
An alternative new video-guided minimally invasive approach involving a 4- to 7-cm lateral thoracotomy, completely avoiding sternotomy, has been developed, with the hope that it should speed physical recovery function after surgery and reduce postoperative complications and costs by reducing hospital stay.
Dr. Akowuah et al. note that uptake of minithoracotomy is variable, with low rates in the United States and the United Kingdom but high rates in Germany. They say that this variation is attributable to the absence of high-quality evidence from randomized trials demonstrating equivalent or superior benefits, compared with sternotomy, and there are also concerns that the increased technical complexity of minithoracotomy may impair the ability to repair complex valve lesions or increase perioperative complications, particularly vascular injuries and stroke.
The U.K. Mini Mitral trial was therefore conducted to compare the effectiveness and safety of minithoracotomy versus sternotomy mitral valve repair.
For the trial, 330 patients with degenerative mitral regurgitation were randomized to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.
The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) physical functioning scale 12 weeks after the surgery.
This failed to show superiority of minithoracotomy, with a mean difference of 0.68 (95% confidence interval, −1.89 to 3.26) between the two groups.
Analysis of secondary outcomes demonstrated that time spent undertaking moderate to vigorous physical activity was higher among participants receiving minithoracotomy at 6 weeks, although the treatment effect was small at an average of 9 minutes and was not different at 12 weeks.
Postoperative length of hospital stay was reduced after minithoracotomy by 1 day, with a median of 5 days, compared with 6 days after sternotomy.
Although repair techniques were at the discretion of the surgeons and differed between the two procedures, high rates of valve repair and low rates of recurrent mitral regurgitation were observed in both groups. Cardiopulmonary bypass times were longer with minithoracotomy, but postoperative complications and adverse events were similar.
There was no difference between the two groups with respect to the prespecified safety outcome of death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year, which occurred in 5.4% of patients undergoing minithoracotomy and 6.1% of those undergoing sternotomy.
“These findings can inform shared decision-making and treatment guidelines,” the authors conclude.
Approach ‘may appeal to patients’
In an editorial accompanying the publication of the study in JAMA, Maurice Enriquez-Sarano, MD, Minneapolis Heart Institute, Minnesota, says the results should be integrated into patient management.
“Mini-thoracotomy mitral repair carried low risk and was highly effective compared with sternotomy. It can thus be applied successfully by surgeons who achieve the necessary expertise,” he notes.
“Mini-thoracotomy may appeal to patients because the procedure is less disfiguring than sternotomy. The early (6-week) benefit, albeit small and transient, is important to patients,” he adds.
The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reports no relevant financial relationships with industry. Dr. Enriquez-Sarano reports receiving consulting fees from Edwards Lifesciences, Artivion, ChemImage, HighLife, and Corcym.
A version of this article first appeared on Medscape.com.
AHA flags CV risk with lead, cadmium, and arsenic exposure
in a new scientific statement.
“In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, said in an interview.
“For the most part, as cardiologists, we are used to risk factors we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Dr. Lamas, chairman of medicine and chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla.
The statement addressing contaminant metals as CV risk factors was published online in the Journal of the American Heart Association.
Involuntary exposure harms the heart
Exposure to contaminant metals most often happens involuntarily through air, water, soil, and food, and extensive industrial and public use, the writing group notes.
These contaminant metals interfere with critical intracellular reactions and functions, leading to oxidative stress and chronic inflammation; this in turn leads to endothelial dysfunction, hypertension, epigenetic dysregulation, dyslipidemia, and changes in myocardial excitation and contractile function, the authors point out.
Lead, cadmium, and arsenic have been linked to subclinical atherosclerosis, coronary artery stenosis and calcification, as well as to an increased risk for ischemic heart disease and stroke, left ventricular hypertrophy, and heart failure and peripheral artery disease.
Epidemiologic studies show that exposure to lead, cadmium, or arsenic is associated with cardiovascular death mostly attributable to ischemic heart disease. In the United States alone, one study suggested that more than 450,000 deaths annually could be attributed to lead exposure.
“This is a global issue in which lower-income communities are disproportionately exposed to toxic metals through contaminated air, water, and soil,” Ana Navas-Acien, MD, PhD, vice chair of the statement writing group, said in a news release.
“Addressing metal exposure in these populations may provide a strategy to reduce cardiovascular disease disparities and advance environmental justice,” adds Dr. Navas-Acien, professor of environmental health sciences at Columbia University, New York.
Dr. Lamas said in an interview that the writing group is “hopeful that there will be a multilevel response” to publication of the scientific statement.
“On the societal level, we believe more effort can be made to measure these pollutants and protect the public. On the physician level, knowledge of metal levels could become part of the routine risk evaluation of the cardiac patient. On the individual level, patients can try to avoid these pollutants, by knowing arsenic levels of well-water, lead and cadmium levels of drinking water, avoiding tobacco and vaping, and using filters when available or necessary,” Dr. Lamas said.
“On the scientific level, identifying ubiquitous pollutants should spur scientists and pharmaceutical companies to develop preventive and therapeutic approaches.”
Finally, clinical trials should be encouraged to assess existing drugs that can remove these atherogenic toxins from the body or treat their ill effects. One such trial is expected to be completed within a year, Dr. Lamas added.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Cardiovascular and Stroke Nursing; the Council on Lifestyle and Cardiometabolic Health; the Council on Peripheral Vascular Disease; and the Council on the Kidney in Cardiovascular Disease.
A version of this article originally appeared on Medscape.com.
in a new scientific statement.
“In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, said in an interview.
“For the most part, as cardiologists, we are used to risk factors we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Dr. Lamas, chairman of medicine and chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla.
The statement addressing contaminant metals as CV risk factors was published online in the Journal of the American Heart Association.
Involuntary exposure harms the heart
Exposure to contaminant metals most often happens involuntarily through air, water, soil, and food, and extensive industrial and public use, the writing group notes.
These contaminant metals interfere with critical intracellular reactions and functions, leading to oxidative stress and chronic inflammation; this in turn leads to endothelial dysfunction, hypertension, epigenetic dysregulation, dyslipidemia, and changes in myocardial excitation and contractile function, the authors point out.
Lead, cadmium, and arsenic have been linked to subclinical atherosclerosis, coronary artery stenosis and calcification, as well as to an increased risk for ischemic heart disease and stroke, left ventricular hypertrophy, and heart failure and peripheral artery disease.
Epidemiologic studies show that exposure to lead, cadmium, or arsenic is associated with cardiovascular death mostly attributable to ischemic heart disease. In the United States alone, one study suggested that more than 450,000 deaths annually could be attributed to lead exposure.
“This is a global issue in which lower-income communities are disproportionately exposed to toxic metals through contaminated air, water, and soil,” Ana Navas-Acien, MD, PhD, vice chair of the statement writing group, said in a news release.
“Addressing metal exposure in these populations may provide a strategy to reduce cardiovascular disease disparities and advance environmental justice,” adds Dr. Navas-Acien, professor of environmental health sciences at Columbia University, New York.
Dr. Lamas said in an interview that the writing group is “hopeful that there will be a multilevel response” to publication of the scientific statement.
“On the societal level, we believe more effort can be made to measure these pollutants and protect the public. On the physician level, knowledge of metal levels could become part of the routine risk evaluation of the cardiac patient. On the individual level, patients can try to avoid these pollutants, by knowing arsenic levels of well-water, lead and cadmium levels of drinking water, avoiding tobacco and vaping, and using filters when available or necessary,” Dr. Lamas said.
“On the scientific level, identifying ubiquitous pollutants should spur scientists and pharmaceutical companies to develop preventive and therapeutic approaches.”
Finally, clinical trials should be encouraged to assess existing drugs that can remove these atherogenic toxins from the body or treat their ill effects. One such trial is expected to be completed within a year, Dr. Lamas added.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Cardiovascular and Stroke Nursing; the Council on Lifestyle and Cardiometabolic Health; the Council on Peripheral Vascular Disease; and the Council on the Kidney in Cardiovascular Disease.
A version of this article originally appeared on Medscape.com.
in a new scientific statement.
“In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, said in an interview.
“For the most part, as cardiologists, we are used to risk factors we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Dr. Lamas, chairman of medicine and chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla.
The statement addressing contaminant metals as CV risk factors was published online in the Journal of the American Heart Association.
Involuntary exposure harms the heart
Exposure to contaminant metals most often happens involuntarily through air, water, soil, and food, and extensive industrial and public use, the writing group notes.
These contaminant metals interfere with critical intracellular reactions and functions, leading to oxidative stress and chronic inflammation; this in turn leads to endothelial dysfunction, hypertension, epigenetic dysregulation, dyslipidemia, and changes in myocardial excitation and contractile function, the authors point out.
Lead, cadmium, and arsenic have been linked to subclinical atherosclerosis, coronary artery stenosis and calcification, as well as to an increased risk for ischemic heart disease and stroke, left ventricular hypertrophy, and heart failure and peripheral artery disease.
Epidemiologic studies show that exposure to lead, cadmium, or arsenic is associated with cardiovascular death mostly attributable to ischemic heart disease. In the United States alone, one study suggested that more than 450,000 deaths annually could be attributed to lead exposure.
“This is a global issue in which lower-income communities are disproportionately exposed to toxic metals through contaminated air, water, and soil,” Ana Navas-Acien, MD, PhD, vice chair of the statement writing group, said in a news release.
“Addressing metal exposure in these populations may provide a strategy to reduce cardiovascular disease disparities and advance environmental justice,” adds Dr. Navas-Acien, professor of environmental health sciences at Columbia University, New York.
Dr. Lamas said in an interview that the writing group is “hopeful that there will be a multilevel response” to publication of the scientific statement.
“On the societal level, we believe more effort can be made to measure these pollutants and protect the public. On the physician level, knowledge of metal levels could become part of the routine risk evaluation of the cardiac patient. On the individual level, patients can try to avoid these pollutants, by knowing arsenic levels of well-water, lead and cadmium levels of drinking water, avoiding tobacco and vaping, and using filters when available or necessary,” Dr. Lamas said.
“On the scientific level, identifying ubiquitous pollutants should spur scientists and pharmaceutical companies to develop preventive and therapeutic approaches.”
Finally, clinical trials should be encouraged to assess existing drugs that can remove these atherogenic toxins from the body or treat their ill effects. One such trial is expected to be completed within a year, Dr. Lamas added.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Cardiovascular and Stroke Nursing; the Council on Lifestyle and Cardiometabolic Health; the Council on Peripheral Vascular Disease; and the Council on the Kidney in Cardiovascular Disease.
A version of this article originally appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Ticagrelor may reduce brain lesions after carotid stenting
MUNICH – secondary endpoint results of the PRECISE-MRI trial suggest.
More than 200 patients with carotid artery stenosis underwent MRI and were randomized to ticagrelor or clopidogrel before undergoing CAS. They then had two follow-up MRIs to assess the presence of emergent ischemic lesions.
Although the trial, which was stopped early, failed to show a difference between the two treatments in the primary endpoint – occurrence of at least one ischemic lesion – it did show that ticagrelor was associated with significant reductions in secondary endpoints including the total number and total volume of new lesions.
There were also significantly fewer cases of a composite of adverse clinical events with ticagrelor versus clopidogrel, but no difference in rates of hemorrhagic bleeds.
The research was presented at the annual European Stroke Organisation Conference .
Highlighting the failure of the trial to meet its primary endpoint, study presenter Leo Bonati, MD, head of the Stroke Center, Rena Rheinfelden, University Hospital Basel (Switzerland), pointed out that the proportion of patients with one or more ischemic brain lesions was “much higher than expected.”
Based on the secondary outcomes, the study nevertheless indicates that, “compared with clopidogrel, ticagrelor reduces the total burden of ischemic brain lesions occurring during CAS,” he said.
Ticagrelor is therefore a “safe alternative to clopidogrel as an add-on to aspirin to cover carotid artery stent procedures.”
Dr. Bonati cautioned, however, that the findings are preliminary.
‘Promising’ results
Session cochair Else Charlotte Sandset, MD, PhD, a consultant neurologist in the stroke unit, department of neurology, Oslo University Hospital, called the results “interesting” and “promising.”
She said in an interview that they “also provide us with an additional option” in the management of patients undergoing CAS.
Dr. Sandset suggested that “it may have been a little bit hard to prove the primary endpoint” chosen for the trial, but believes that the secondary endpoint results “are very interesting.”
“Of course, we would need more data and further trials to provide some reassurance that we can use ticagrelor in this fashion,” she said.
Major complication
Dr. Bonati began by noting that the major procedural complication of CAS is embolic stroke, but this may be prevented with optimized antiplatelet therapy.
Previous studies have shown that ticagrelor is superior to clopidogrel as an add-on to aspirin in reducing rates of major adverse cardiovascular events in acute coronary syndrome patients undergoing percutaneous coronary intervention.
Adding the drug to aspirin is also superior to aspirin alone in preventing recurrent stroke in patients with minor stroke or transient ischemic attack, Dr. Bonati said.
To examine whether ticagrelor is superior to clopidogrel as an add-on to aspirin in preventing ischemic brain lesions during CAS, the team conducted a randomized, open, active-controlled trial.
They recruited patients with ≥ 50% symptomatic or asymptomatic carotid stenosis undergoing CAS in line with local guidelines and performed a baseline MRI scan and clinical examination.
The patients were then randomized to ticagrelor or clopidogrel plus aspirin 1-3 days before undergoing CAS. A second MRI and clinical examination, as well as an ultrasound scan, was performed at 1 to 3 days post-CAS, with a third set of examinations performed at 28-32 days after the procedure.
The study included 14 sites in Belgium, Germany, Italy, the Netherlands, Switzerland, and the United Kingdom. Enrollment was stopped after 209 of the originally planned 370 patients, “due to slow recruitment and a lack of further funding,” Dr. Bonati said.
Of those, 207 patients were included in the intention-to-treat safety analysis, and 172 in the per-protocol efficacy analysis.
The mean age of the patients was 69.0-69.5 years in the two treatment groups, and 67%-71% were male. Dr. Bonati noted that 52%-55% of the patients had symptomatic stenosis, and that in 83%-88% the stenosis was severe.
The majority (79%-82%) of patients had hypertension, alongside hypercholesterolemia, at 76% in both treatment groups.
Dr. Bonati showed that there was no significant difference in the primary efficacy outcome of the presence of at least new ischemic brain lesion on the second or third MRI, at 74.7% for patients given ticagrelor versus 79.8% with clopidogrel, or a relative risk of 0.94 (95% confidence interval, 0.79-1.10; P = .43).
However, there was a significant reduction in the number of new ischemic lesions, at a median of 2 (interquartile range, 0.5-5.5) with ticagrelor versus 3 with clopidogrel (IQR, 1-8), or an exponential beta value of 0.63 (95% CI, 0.42-0.95; P = .027).
Ticagrelor was also associated with a significant reduction in the total volume of lesions, at a median of 66 mcL (IQR, 2.5-2.19) versus 91 mcL (IQR, 25-394) for clopidogrel, or an exponential beta value of 0.30 (95% CI, 0.10-0.92; P = .030).
Patients assigned to ticagrelor also had a significantly lower rate of the primary clinical safety outcome, a composite of stroke, myocardial infarction, major bleeding, or cardiovascular death, at 2.9% versus 7.8% (relative risk, 0.36; 95% CI, 0.08-1.20). This was driven by a reduction in rates of post-CAS stroke.
Dr. Bonati noted that there was no significant difference in the presence of at least one hemorrhagic lesion after CAS, at 42.7% with ticagrelor and 47.6% in the clopidogrel group (RR, 0.90; 95% CI, 0.63-1.26).
There was also a similar rate of microbleeds between the two treatment groups, at 36.6% in patients given ticagrelor and 47.6% in those assigned to clopidogrel.
The study was investigator initiated and funded by an unrestricted research grant from AstraZeneca. No relevant financial relationships were declared.
A version of this article first appeared on Medscape.com.
MUNICH – secondary endpoint results of the PRECISE-MRI trial suggest.
More than 200 patients with carotid artery stenosis underwent MRI and were randomized to ticagrelor or clopidogrel before undergoing CAS. They then had two follow-up MRIs to assess the presence of emergent ischemic lesions.
Although the trial, which was stopped early, failed to show a difference between the two treatments in the primary endpoint – occurrence of at least one ischemic lesion – it did show that ticagrelor was associated with significant reductions in secondary endpoints including the total number and total volume of new lesions.
There were also significantly fewer cases of a composite of adverse clinical events with ticagrelor versus clopidogrel, but no difference in rates of hemorrhagic bleeds.
The research was presented at the annual European Stroke Organisation Conference .
Highlighting the failure of the trial to meet its primary endpoint, study presenter Leo Bonati, MD, head of the Stroke Center, Rena Rheinfelden, University Hospital Basel (Switzerland), pointed out that the proportion of patients with one or more ischemic brain lesions was “much higher than expected.”
Based on the secondary outcomes, the study nevertheless indicates that, “compared with clopidogrel, ticagrelor reduces the total burden of ischemic brain lesions occurring during CAS,” he said.
Ticagrelor is therefore a “safe alternative to clopidogrel as an add-on to aspirin to cover carotid artery stent procedures.”
Dr. Bonati cautioned, however, that the findings are preliminary.
‘Promising’ results
Session cochair Else Charlotte Sandset, MD, PhD, a consultant neurologist in the stroke unit, department of neurology, Oslo University Hospital, called the results “interesting” and “promising.”
She said in an interview that they “also provide us with an additional option” in the management of patients undergoing CAS.
Dr. Sandset suggested that “it may have been a little bit hard to prove the primary endpoint” chosen for the trial, but believes that the secondary endpoint results “are very interesting.”
“Of course, we would need more data and further trials to provide some reassurance that we can use ticagrelor in this fashion,” she said.
Major complication
Dr. Bonati began by noting that the major procedural complication of CAS is embolic stroke, but this may be prevented with optimized antiplatelet therapy.
Previous studies have shown that ticagrelor is superior to clopidogrel as an add-on to aspirin in reducing rates of major adverse cardiovascular events in acute coronary syndrome patients undergoing percutaneous coronary intervention.
Adding the drug to aspirin is also superior to aspirin alone in preventing recurrent stroke in patients with minor stroke or transient ischemic attack, Dr. Bonati said.
To examine whether ticagrelor is superior to clopidogrel as an add-on to aspirin in preventing ischemic brain lesions during CAS, the team conducted a randomized, open, active-controlled trial.
They recruited patients with ≥ 50% symptomatic or asymptomatic carotid stenosis undergoing CAS in line with local guidelines and performed a baseline MRI scan and clinical examination.
The patients were then randomized to ticagrelor or clopidogrel plus aspirin 1-3 days before undergoing CAS. A second MRI and clinical examination, as well as an ultrasound scan, was performed at 1 to 3 days post-CAS, with a third set of examinations performed at 28-32 days after the procedure.
The study included 14 sites in Belgium, Germany, Italy, the Netherlands, Switzerland, and the United Kingdom. Enrollment was stopped after 209 of the originally planned 370 patients, “due to slow recruitment and a lack of further funding,” Dr. Bonati said.
Of those, 207 patients were included in the intention-to-treat safety analysis, and 172 in the per-protocol efficacy analysis.
The mean age of the patients was 69.0-69.5 years in the two treatment groups, and 67%-71% were male. Dr. Bonati noted that 52%-55% of the patients had symptomatic stenosis, and that in 83%-88% the stenosis was severe.
The majority (79%-82%) of patients had hypertension, alongside hypercholesterolemia, at 76% in both treatment groups.
Dr. Bonati showed that there was no significant difference in the primary efficacy outcome of the presence of at least new ischemic brain lesion on the second or third MRI, at 74.7% for patients given ticagrelor versus 79.8% with clopidogrel, or a relative risk of 0.94 (95% confidence interval, 0.79-1.10; P = .43).
However, there was a significant reduction in the number of new ischemic lesions, at a median of 2 (interquartile range, 0.5-5.5) with ticagrelor versus 3 with clopidogrel (IQR, 1-8), or an exponential beta value of 0.63 (95% CI, 0.42-0.95; P = .027).
Ticagrelor was also associated with a significant reduction in the total volume of lesions, at a median of 66 mcL (IQR, 2.5-2.19) versus 91 mcL (IQR, 25-394) for clopidogrel, or an exponential beta value of 0.30 (95% CI, 0.10-0.92; P = .030).
Patients assigned to ticagrelor also had a significantly lower rate of the primary clinical safety outcome, a composite of stroke, myocardial infarction, major bleeding, or cardiovascular death, at 2.9% versus 7.8% (relative risk, 0.36; 95% CI, 0.08-1.20). This was driven by a reduction in rates of post-CAS stroke.
Dr. Bonati noted that there was no significant difference in the presence of at least one hemorrhagic lesion after CAS, at 42.7% with ticagrelor and 47.6% in the clopidogrel group (RR, 0.90; 95% CI, 0.63-1.26).
There was also a similar rate of microbleeds between the two treatment groups, at 36.6% in patients given ticagrelor and 47.6% in those assigned to clopidogrel.
The study was investigator initiated and funded by an unrestricted research grant from AstraZeneca. No relevant financial relationships were declared.
A version of this article first appeared on Medscape.com.
MUNICH – secondary endpoint results of the PRECISE-MRI trial suggest.
More than 200 patients with carotid artery stenosis underwent MRI and were randomized to ticagrelor or clopidogrel before undergoing CAS. They then had two follow-up MRIs to assess the presence of emergent ischemic lesions.
Although the trial, which was stopped early, failed to show a difference between the two treatments in the primary endpoint – occurrence of at least one ischemic lesion – it did show that ticagrelor was associated with significant reductions in secondary endpoints including the total number and total volume of new lesions.
There were also significantly fewer cases of a composite of adverse clinical events with ticagrelor versus clopidogrel, but no difference in rates of hemorrhagic bleeds.
The research was presented at the annual European Stroke Organisation Conference .
Highlighting the failure of the trial to meet its primary endpoint, study presenter Leo Bonati, MD, head of the Stroke Center, Rena Rheinfelden, University Hospital Basel (Switzerland), pointed out that the proportion of patients with one or more ischemic brain lesions was “much higher than expected.”
Based on the secondary outcomes, the study nevertheless indicates that, “compared with clopidogrel, ticagrelor reduces the total burden of ischemic brain lesions occurring during CAS,” he said.
Ticagrelor is therefore a “safe alternative to clopidogrel as an add-on to aspirin to cover carotid artery stent procedures.”
Dr. Bonati cautioned, however, that the findings are preliminary.
‘Promising’ results
Session cochair Else Charlotte Sandset, MD, PhD, a consultant neurologist in the stroke unit, department of neurology, Oslo University Hospital, called the results “interesting” and “promising.”
She said in an interview that they “also provide us with an additional option” in the management of patients undergoing CAS.
Dr. Sandset suggested that “it may have been a little bit hard to prove the primary endpoint” chosen for the trial, but believes that the secondary endpoint results “are very interesting.”
“Of course, we would need more data and further trials to provide some reassurance that we can use ticagrelor in this fashion,” she said.
Major complication
Dr. Bonati began by noting that the major procedural complication of CAS is embolic stroke, but this may be prevented with optimized antiplatelet therapy.
Previous studies have shown that ticagrelor is superior to clopidogrel as an add-on to aspirin in reducing rates of major adverse cardiovascular events in acute coronary syndrome patients undergoing percutaneous coronary intervention.
Adding the drug to aspirin is also superior to aspirin alone in preventing recurrent stroke in patients with minor stroke or transient ischemic attack, Dr. Bonati said.
To examine whether ticagrelor is superior to clopidogrel as an add-on to aspirin in preventing ischemic brain lesions during CAS, the team conducted a randomized, open, active-controlled trial.
They recruited patients with ≥ 50% symptomatic or asymptomatic carotid stenosis undergoing CAS in line with local guidelines and performed a baseline MRI scan and clinical examination.
The patients were then randomized to ticagrelor or clopidogrel plus aspirin 1-3 days before undergoing CAS. A second MRI and clinical examination, as well as an ultrasound scan, was performed at 1 to 3 days post-CAS, with a third set of examinations performed at 28-32 days after the procedure.
The study included 14 sites in Belgium, Germany, Italy, the Netherlands, Switzerland, and the United Kingdom. Enrollment was stopped after 209 of the originally planned 370 patients, “due to slow recruitment and a lack of further funding,” Dr. Bonati said.
Of those, 207 patients were included in the intention-to-treat safety analysis, and 172 in the per-protocol efficacy analysis.
The mean age of the patients was 69.0-69.5 years in the two treatment groups, and 67%-71% were male. Dr. Bonati noted that 52%-55% of the patients had symptomatic stenosis, and that in 83%-88% the stenosis was severe.
The majority (79%-82%) of patients had hypertension, alongside hypercholesterolemia, at 76% in both treatment groups.
Dr. Bonati showed that there was no significant difference in the primary efficacy outcome of the presence of at least new ischemic brain lesion on the second or third MRI, at 74.7% for patients given ticagrelor versus 79.8% with clopidogrel, or a relative risk of 0.94 (95% confidence interval, 0.79-1.10; P = .43).
However, there was a significant reduction in the number of new ischemic lesions, at a median of 2 (interquartile range, 0.5-5.5) with ticagrelor versus 3 with clopidogrel (IQR, 1-8), or an exponential beta value of 0.63 (95% CI, 0.42-0.95; P = .027).
Ticagrelor was also associated with a significant reduction in the total volume of lesions, at a median of 66 mcL (IQR, 2.5-2.19) versus 91 mcL (IQR, 25-394) for clopidogrel, or an exponential beta value of 0.30 (95% CI, 0.10-0.92; P = .030).
Patients assigned to ticagrelor also had a significantly lower rate of the primary clinical safety outcome, a composite of stroke, myocardial infarction, major bleeding, or cardiovascular death, at 2.9% versus 7.8% (relative risk, 0.36; 95% CI, 0.08-1.20). This was driven by a reduction in rates of post-CAS stroke.
Dr. Bonati noted that there was no significant difference in the presence of at least one hemorrhagic lesion after CAS, at 42.7% with ticagrelor and 47.6% in the clopidogrel group (RR, 0.90; 95% CI, 0.63-1.26).
There was also a similar rate of microbleeds between the two treatment groups, at 36.6% in patients given ticagrelor and 47.6% in those assigned to clopidogrel.
The study was investigator initiated and funded by an unrestricted research grant from AstraZeneca. No relevant financial relationships were declared.
A version of this article first appeared on Medscape.com.
FROM ESOC 2023
Alcohol may curb stress signaling in brain to protect heart
The study shows that light to moderate drinking was associated with lower major adverse cardiovascular events (MACE), and this was partly mediated by decreased stress signaling in the brain.
In addition, the benefit of light to moderate drinking with respect to MACE was most pronounced among people with a history of anxiety, a condition known to be associated with higher stress signaling in the brain.
However, the apparent CVD benefits of light to moderate drinking were counterbalanced by an increased risk of cancer.
“There is no safe level of alcohol consumption,” senior author and cardiologist Ahmed Tawakol, MD, codirector of the Cardiovascular Imaging Research Center at Massachusetts General Hospital, Boston, said in an interview.
“We see cancer risk even at the level that we see some protection from heart disease. And higher amounts of alcohol clearly increase heart disease risk,” Dr. Tawakol said.
The study was published online in the Journal of the American College of Cardiology.
Clear mechanistic link
Chronic stress is associated with MACE via stress-related neural network activity (SNA). Light to moderate alcohol consumption has been linked to lower MACE risk, but the mechanisms behind this connection remain unclear.
“We know that when the neural centers of stress are activated, they trigger downstream changes that result in heart disease. And we’ve long appreciated that alcohol in the short term reduces stress, so we hypothesized that maybe alcohol impacts those stress systems chronically and that might explain its cardiovascular effects,” Dr. Tawakol explained.
The study included roughly 53,000 adults (mean age, 60 years; 60% women) from the Mass General Brigham Biobank. The researchers first evaluated the relationship between light to moderate alcohol consumption and MACE after adjusting for a range of genetic, clinical, lifestyle, and socioeconomic factors.
During mean follow-up of 3.4 years, 1,914 individuals experienced MACE. Light to moderate alcohol consumption (compared to none/minimal) was associated with lower MACE risk (hazard ratio [HR], 0.786; 95% confidence interval [CI], 0.717-0.862; P < .0001) after adjustment for cardiovascular risk factors.
The researchers then studied a subset of 713 individuals who had undergone previous PET/CT brain imaging (primarily for cancer surveillance) to determine the effect of light to moderate alcohol consumption on resting SNA.
They found that light to moderate alcohol consumption correlated with decreased SNA (standardized beta, –0.192; 95% CI, –0.338 to 0.046; P = .01). Lower SNA partially mediated the beneficial effect of light to moderate alcohol intake on MACE risk (odds ratio [OR], –0.040; 95% CI, –0.097 to –0.003; P < .05).
Light to moderate alcohol consumption was associated with larger decreases in MACE risk among individuals with a history of anxiety (HR, 0.60; 95% CI, 0.50-0.72, vs. HR, 1.78; 95% CI, 0.73-0.80; P = .003).
The coauthors of an editorial say the discovery of a “new possible mechanism of action” for why light to moderate alcohol consumption might protect the heart “deserves closer attention in future investigations.”
However, Giovanni de Gaetano, MD, PhD, department of epidemiology and prevention, IRCCS NEUROMED, Pozzilli, Italy, one of the authors, emphasized that individuals who consume alcohol should not “exceed the recommended daily dose limits suggested in many countries and that no abstainer should start to drink, even in moderation, solely for the purpose of improving his/her health outcomes.”
Dr. Tawakol and colleagues said that, given alcohol’s adverse health effects, such as heightened cancer risk, new interventions that have positive effects on the neurobiology of stress but without the harmful effects of alcohol are needed.
To that end, they are studying the effect of exercise, stress-reduction interventions such as meditation, and pharmacologic therapies on stress-associated neural networks, and how they might induce CV benefits.
Dr. Tawakol said in an interview that one “additional important message is that anxiety and other related conditions like depression have really substantial health consequences, including increased MACE. Safer interventions that reduce anxiety may yet prove to reduce the risk of heart disease very nicely.”
The study was supported by the National Institutes of Health. Dr. Tawakol and Dr. de Gaetano have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The study shows that light to moderate drinking was associated with lower major adverse cardiovascular events (MACE), and this was partly mediated by decreased stress signaling in the brain.
In addition, the benefit of light to moderate drinking with respect to MACE was most pronounced among people with a history of anxiety, a condition known to be associated with higher stress signaling in the brain.
However, the apparent CVD benefits of light to moderate drinking were counterbalanced by an increased risk of cancer.
“There is no safe level of alcohol consumption,” senior author and cardiologist Ahmed Tawakol, MD, codirector of the Cardiovascular Imaging Research Center at Massachusetts General Hospital, Boston, said in an interview.
“We see cancer risk even at the level that we see some protection from heart disease. And higher amounts of alcohol clearly increase heart disease risk,” Dr. Tawakol said.
The study was published online in the Journal of the American College of Cardiology.
Clear mechanistic link
Chronic stress is associated with MACE via stress-related neural network activity (SNA). Light to moderate alcohol consumption has been linked to lower MACE risk, but the mechanisms behind this connection remain unclear.
“We know that when the neural centers of stress are activated, they trigger downstream changes that result in heart disease. And we’ve long appreciated that alcohol in the short term reduces stress, so we hypothesized that maybe alcohol impacts those stress systems chronically and that might explain its cardiovascular effects,” Dr. Tawakol explained.
The study included roughly 53,000 adults (mean age, 60 years; 60% women) from the Mass General Brigham Biobank. The researchers first evaluated the relationship between light to moderate alcohol consumption and MACE after adjusting for a range of genetic, clinical, lifestyle, and socioeconomic factors.
During mean follow-up of 3.4 years, 1,914 individuals experienced MACE. Light to moderate alcohol consumption (compared to none/minimal) was associated with lower MACE risk (hazard ratio [HR], 0.786; 95% confidence interval [CI], 0.717-0.862; P < .0001) after adjustment for cardiovascular risk factors.
The researchers then studied a subset of 713 individuals who had undergone previous PET/CT brain imaging (primarily for cancer surveillance) to determine the effect of light to moderate alcohol consumption on resting SNA.
They found that light to moderate alcohol consumption correlated with decreased SNA (standardized beta, –0.192; 95% CI, –0.338 to 0.046; P = .01). Lower SNA partially mediated the beneficial effect of light to moderate alcohol intake on MACE risk (odds ratio [OR], –0.040; 95% CI, –0.097 to –0.003; P < .05).
Light to moderate alcohol consumption was associated with larger decreases in MACE risk among individuals with a history of anxiety (HR, 0.60; 95% CI, 0.50-0.72, vs. HR, 1.78; 95% CI, 0.73-0.80; P = .003).
The coauthors of an editorial say the discovery of a “new possible mechanism of action” for why light to moderate alcohol consumption might protect the heart “deserves closer attention in future investigations.”
However, Giovanni de Gaetano, MD, PhD, department of epidemiology and prevention, IRCCS NEUROMED, Pozzilli, Italy, one of the authors, emphasized that individuals who consume alcohol should not “exceed the recommended daily dose limits suggested in many countries and that no abstainer should start to drink, even in moderation, solely for the purpose of improving his/her health outcomes.”
Dr. Tawakol and colleagues said that, given alcohol’s adverse health effects, such as heightened cancer risk, new interventions that have positive effects on the neurobiology of stress but without the harmful effects of alcohol are needed.
To that end, they are studying the effect of exercise, stress-reduction interventions such as meditation, and pharmacologic therapies on stress-associated neural networks, and how they might induce CV benefits.
Dr. Tawakol said in an interview that one “additional important message is that anxiety and other related conditions like depression have really substantial health consequences, including increased MACE. Safer interventions that reduce anxiety may yet prove to reduce the risk of heart disease very nicely.”
The study was supported by the National Institutes of Health. Dr. Tawakol and Dr. de Gaetano have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The study shows that light to moderate drinking was associated with lower major adverse cardiovascular events (MACE), and this was partly mediated by decreased stress signaling in the brain.
In addition, the benefit of light to moderate drinking with respect to MACE was most pronounced among people with a history of anxiety, a condition known to be associated with higher stress signaling in the brain.
However, the apparent CVD benefits of light to moderate drinking were counterbalanced by an increased risk of cancer.
“There is no safe level of alcohol consumption,” senior author and cardiologist Ahmed Tawakol, MD, codirector of the Cardiovascular Imaging Research Center at Massachusetts General Hospital, Boston, said in an interview.
“We see cancer risk even at the level that we see some protection from heart disease. And higher amounts of alcohol clearly increase heart disease risk,” Dr. Tawakol said.
The study was published online in the Journal of the American College of Cardiology.
Clear mechanistic link
Chronic stress is associated with MACE via stress-related neural network activity (SNA). Light to moderate alcohol consumption has been linked to lower MACE risk, but the mechanisms behind this connection remain unclear.
“We know that when the neural centers of stress are activated, they trigger downstream changes that result in heart disease. And we’ve long appreciated that alcohol in the short term reduces stress, so we hypothesized that maybe alcohol impacts those stress systems chronically and that might explain its cardiovascular effects,” Dr. Tawakol explained.
The study included roughly 53,000 adults (mean age, 60 years; 60% women) from the Mass General Brigham Biobank. The researchers first evaluated the relationship between light to moderate alcohol consumption and MACE after adjusting for a range of genetic, clinical, lifestyle, and socioeconomic factors.
During mean follow-up of 3.4 years, 1,914 individuals experienced MACE. Light to moderate alcohol consumption (compared to none/minimal) was associated with lower MACE risk (hazard ratio [HR], 0.786; 95% confidence interval [CI], 0.717-0.862; P < .0001) after adjustment for cardiovascular risk factors.
The researchers then studied a subset of 713 individuals who had undergone previous PET/CT brain imaging (primarily for cancer surveillance) to determine the effect of light to moderate alcohol consumption on resting SNA.
They found that light to moderate alcohol consumption correlated with decreased SNA (standardized beta, –0.192; 95% CI, –0.338 to 0.046; P = .01). Lower SNA partially mediated the beneficial effect of light to moderate alcohol intake on MACE risk (odds ratio [OR], –0.040; 95% CI, –0.097 to –0.003; P < .05).
Light to moderate alcohol consumption was associated with larger decreases in MACE risk among individuals with a history of anxiety (HR, 0.60; 95% CI, 0.50-0.72, vs. HR, 1.78; 95% CI, 0.73-0.80; P = .003).
The coauthors of an editorial say the discovery of a “new possible mechanism of action” for why light to moderate alcohol consumption might protect the heart “deserves closer attention in future investigations.”
However, Giovanni de Gaetano, MD, PhD, department of epidemiology and prevention, IRCCS NEUROMED, Pozzilli, Italy, one of the authors, emphasized that individuals who consume alcohol should not “exceed the recommended daily dose limits suggested in many countries and that no abstainer should start to drink, even in moderation, solely for the purpose of improving his/her health outcomes.”
Dr. Tawakol and colleagues said that, given alcohol’s adverse health effects, such as heightened cancer risk, new interventions that have positive effects on the neurobiology of stress but without the harmful effects of alcohol are needed.
To that end, they are studying the effect of exercise, stress-reduction interventions such as meditation, and pharmacologic therapies on stress-associated neural networks, and how they might induce CV benefits.
Dr. Tawakol said in an interview that one “additional important message is that anxiety and other related conditions like depression have really substantial health consequences, including increased MACE. Safer interventions that reduce anxiety may yet prove to reduce the risk of heart disease very nicely.”
The study was supported by the National Institutes of Health. Dr. Tawakol and Dr. de Gaetano have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
The cardiopulmonary effects of mask wearing
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.
There was a time when I would have had to explain to you what an N95 mask is, how it is designed to filter out 95% of fine particles, defined as stuff in the air less than 2.5 microns in size.
But of course, you know that now. The N95 had its moment – a moment that seemed to be passing as the concentration of airborne coronavirus particles decreased.
But, as the poet said, all that is less than 2.5 microns in size is not coronavirus. Wildfire smoke is also chock full of fine particulate matter. And so, N95s are having something of a comeback.
That’s why an article that took a deep look at what happens to our cardiovascular system when we wear N95 masks caught my eye.
Mask wearing has been the subject of intense debate around the country. While the vast majority of evidence, as well as the personal experience of thousands of doctors, suggests that wearing a mask has no significant physiologic effects, it’s not hard to find those who suggest that mask wearing depletes oxygen levels, or leads to infection, or has other bizarre effects.
In a world of conflicting opinions, a controlled study is a wonderful thing, and that’s what appeared in JAMA Network Open.
This isn’t a huge study, but it’s big enough to make some important conclusions. Thirty individuals, all young and healthy, half female, were enrolled. Each participant spent 3 days in a metabolic chamber; this is essentially a giant, airtight room where all the inputs (oxygen levels and so on) and outputs (carbon dioxide levels and so on) can be precisely measured.
After a day of getting used to the environment, the participants spent a day either wearing an N95 mask or not for 16 waking hours. On the next day, they switched. Every other variable was controlled, from the calories in their diet to the temperature of the room itself.
They engaged in light exercise twice during the day – riding a stationary bike – and a host of physiologic parameters were measured. The question being, would the wearing of the mask for 16 hours straight change anything?
And the answer is yes, some things changed, but not by much.
Here’s a graph of the heart rate over time. You can see some separation, with higher heart rates during the mask-wearing day, particularly around 11 a.m. – when light exercise was scheduled.
Zooming in on the exercise period makes the difference more clear. The heart rate was about eight beats/min higher while masked and engaging in exercise. Systolic blood pressure was about 6 mm Hg higher. Oxygen saturation was lower by 0.7%.
So yes, exercising while wearing an N95 mask might be different from exercising without an N95 mask. But nothing here looks dangerous to me. The 0.7% decrease in oxygen saturation is smaller than the typical measurement error of a pulse oximeter. The authors write that venous pH decreased during the masked day, which is of more interest to me as a nephrologist, but they don’t show that data even in the supplement. I suspect it didn’t decrease much.
They also showed that respiratory rate during exercise decreased in the masked condition. That doesn’t really make sense when you think about it in the context of the other findings, which are all suggestive of increased metabolic rate and sympathetic drive. Does that call the whole procedure into question? No, but it’s worth noting.
These were young, healthy people. You could certainly argue that those with more vulnerable cardiopulmonary status might have had different effects from mask wearing, but without a specific study in those people, it’s just conjecture. Clearly, this study lets us conclude that mask wearing at rest has less of an effect than mask wearing during exercise.
But remember that, in reality, we are wearing masks for a reason. One could imagine a study where this metabolic chamber was filled with wildfire smoke at a concentration similar to what we saw in New York. In that situation, we might find that wearing an N95 is quite helpful. The thing is, studying masks in isolation is useful because you can control so many variables. But masks aren’t used in isolation. In fact, that’s sort of their defining characteristic.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.
There was a time when I would have had to explain to you what an N95 mask is, how it is designed to filter out 95% of fine particles, defined as stuff in the air less than 2.5 microns in size.
But of course, you know that now. The N95 had its moment – a moment that seemed to be passing as the concentration of airborne coronavirus particles decreased.
But, as the poet said, all that is less than 2.5 microns in size is not coronavirus. Wildfire smoke is also chock full of fine particulate matter. And so, N95s are having something of a comeback.
That’s why an article that took a deep look at what happens to our cardiovascular system when we wear N95 masks caught my eye.
Mask wearing has been the subject of intense debate around the country. While the vast majority of evidence, as well as the personal experience of thousands of doctors, suggests that wearing a mask has no significant physiologic effects, it’s not hard to find those who suggest that mask wearing depletes oxygen levels, or leads to infection, or has other bizarre effects.
In a world of conflicting opinions, a controlled study is a wonderful thing, and that’s what appeared in JAMA Network Open.
This isn’t a huge study, but it’s big enough to make some important conclusions. Thirty individuals, all young and healthy, half female, were enrolled. Each participant spent 3 days in a metabolic chamber; this is essentially a giant, airtight room where all the inputs (oxygen levels and so on) and outputs (carbon dioxide levels and so on) can be precisely measured.
After a day of getting used to the environment, the participants spent a day either wearing an N95 mask or not for 16 waking hours. On the next day, they switched. Every other variable was controlled, from the calories in their diet to the temperature of the room itself.
They engaged in light exercise twice during the day – riding a stationary bike – and a host of physiologic parameters were measured. The question being, would the wearing of the mask for 16 hours straight change anything?
And the answer is yes, some things changed, but not by much.
Here’s a graph of the heart rate over time. You can see some separation, with higher heart rates during the mask-wearing day, particularly around 11 a.m. – when light exercise was scheduled.
Zooming in on the exercise period makes the difference more clear. The heart rate was about eight beats/min higher while masked and engaging in exercise. Systolic blood pressure was about 6 mm Hg higher. Oxygen saturation was lower by 0.7%.
So yes, exercising while wearing an N95 mask might be different from exercising without an N95 mask. But nothing here looks dangerous to me. The 0.7% decrease in oxygen saturation is smaller than the typical measurement error of a pulse oximeter. The authors write that venous pH decreased during the masked day, which is of more interest to me as a nephrologist, but they don’t show that data even in the supplement. I suspect it didn’t decrease much.
They also showed that respiratory rate during exercise decreased in the masked condition. That doesn’t really make sense when you think about it in the context of the other findings, which are all suggestive of increased metabolic rate and sympathetic drive. Does that call the whole procedure into question? No, but it’s worth noting.
These were young, healthy people. You could certainly argue that those with more vulnerable cardiopulmonary status might have had different effects from mask wearing, but without a specific study in those people, it’s just conjecture. Clearly, this study lets us conclude that mask wearing at rest has less of an effect than mask wearing during exercise.
But remember that, in reality, we are wearing masks for a reason. One could imagine a study where this metabolic chamber was filled with wildfire smoke at a concentration similar to what we saw in New York. In that situation, we might find that wearing an N95 is quite helpful. The thing is, studying masks in isolation is useful because you can control so many variables. But masks aren’t used in isolation. In fact, that’s sort of their defining characteristic.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.
There was a time when I would have had to explain to you what an N95 mask is, how it is designed to filter out 95% of fine particles, defined as stuff in the air less than 2.5 microns in size.
But of course, you know that now. The N95 had its moment – a moment that seemed to be passing as the concentration of airborne coronavirus particles decreased.
But, as the poet said, all that is less than 2.5 microns in size is not coronavirus. Wildfire smoke is also chock full of fine particulate matter. And so, N95s are having something of a comeback.
That’s why an article that took a deep look at what happens to our cardiovascular system when we wear N95 masks caught my eye.
Mask wearing has been the subject of intense debate around the country. While the vast majority of evidence, as well as the personal experience of thousands of doctors, suggests that wearing a mask has no significant physiologic effects, it’s not hard to find those who suggest that mask wearing depletes oxygen levels, or leads to infection, or has other bizarre effects.
In a world of conflicting opinions, a controlled study is a wonderful thing, and that’s what appeared in JAMA Network Open.
This isn’t a huge study, but it’s big enough to make some important conclusions. Thirty individuals, all young and healthy, half female, were enrolled. Each participant spent 3 days in a metabolic chamber; this is essentially a giant, airtight room where all the inputs (oxygen levels and so on) and outputs (carbon dioxide levels and so on) can be precisely measured.
After a day of getting used to the environment, the participants spent a day either wearing an N95 mask or not for 16 waking hours. On the next day, they switched. Every other variable was controlled, from the calories in their diet to the temperature of the room itself.
They engaged in light exercise twice during the day – riding a stationary bike – and a host of physiologic parameters were measured. The question being, would the wearing of the mask for 16 hours straight change anything?
And the answer is yes, some things changed, but not by much.
Here’s a graph of the heart rate over time. You can see some separation, with higher heart rates during the mask-wearing day, particularly around 11 a.m. – when light exercise was scheduled.
Zooming in on the exercise period makes the difference more clear. The heart rate was about eight beats/min higher while masked and engaging in exercise. Systolic blood pressure was about 6 mm Hg higher. Oxygen saturation was lower by 0.7%.
So yes, exercising while wearing an N95 mask might be different from exercising without an N95 mask. But nothing here looks dangerous to me. The 0.7% decrease in oxygen saturation is smaller than the typical measurement error of a pulse oximeter. The authors write that venous pH decreased during the masked day, which is of more interest to me as a nephrologist, but they don’t show that data even in the supplement. I suspect it didn’t decrease much.
They also showed that respiratory rate during exercise decreased in the masked condition. That doesn’t really make sense when you think about it in the context of the other findings, which are all suggestive of increased metabolic rate and sympathetic drive. Does that call the whole procedure into question? No, but it’s worth noting.
These were young, healthy people. You could certainly argue that those with more vulnerable cardiopulmonary status might have had different effects from mask wearing, but without a specific study in those people, it’s just conjecture. Clearly, this study lets us conclude that mask wearing at rest has less of an effect than mask wearing during exercise.
But remember that, in reality, we are wearing masks for a reason. One could imagine a study where this metabolic chamber was filled with wildfire smoke at a concentration similar to what we saw in New York. In that situation, we might find that wearing an N95 is quite helpful. The thing is, studying masks in isolation is useful because you can control so many variables. But masks aren’t used in isolation. In fact, that’s sort of their defining characteristic.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Good COP, bad COP. Is this cardiorespiratory measure the best predictor of early death?
according to clinicians who champion the assessment. The COP is easier to obtain than cardiorespiratory measures that require people to exercise to their limit, advocates say; rather than running full speed, someone can walk or lightly jog on a treadmill, with a COP value obtained easily.
But other clinicians argue that maximal exercise tests have many prognostic benefits, and that physicians should do everything in their power to push patients to exercise as hard as possible. In particular, the VO2 max test captures the maximum amount of oxygen someone uses when exercising at their capacity and is the preferred method for measuring cardiovascular endurance.
The COP is a measure of the minimum number of liters of air during breathing required to move one liter of oxygen through the bloodstream. The lower the COP the better, because this means that someone is working less strenuously than someone else to transport the same amount of oxygen, denoting a more efficient interaction between their heart and lungs.
The COP for a fit person might be 15, about 20-25 for a healthy person, and 35 for someone with heart failure, according to Claudio Gil Araújo, MD, PhD, director of research and education at CLINIMEX, an exercise medicine clinic in Rio de Janeiro.
“Max VO2 is very important, that’s indisputable. But when do you use max VO2 in your daily life? Never,” Dr. Araújo said. But almost anyone can generate a COP.
Emerging uses for the COP
“I can put someone on the treadmill or bike, and after 3 or 4 minutes I have the COP. It’s like a walking pace,” Dr. Araújo said. Yet the values are obtained with roughly half the effort as VO2 max. Other clinicians argue exercising to the limits of endurance offers unique clinical insights.
“We should do everything in our power to exercise our patients to maximum. How long a patient is able to go is really important,” said Anu Lala, MD, a cardiologist who specializes in heart failure treatment at Mount Sinai Hospital in New York. A full-capacity exercise test gives useful insights into someone’s heart rate, heart rate recovery, blood pressure, and ECG response to vigorous exercise, Dr. Lala added, all of which are important clues to someone’s overall health.
In 2012 Dr. Araújo coauthored a study that first defined the COP, which is calculated by measuring expired gasses people produce while gently exercising, perhaps to the point where they begin to perspire, and then dividing their breathing capacity by their oxygen uptake every minute. The lowest value obtained during any exercise session is the COP.
Various studies show that higher COP values are associated with more severe heart lesions in patients with congenital heart disease; higher levels of mortality in seemingly healthy male adults; and with worse prognoses in patients with heart failure. These studies all appeared within the last 7 months.
The mortality study, which Dr. Araújo coauthored, compared COP in more than 3,000 U.S. men and women who completed an exercise test from 1973 to 2018 and were tracked for an average of 23 years. Although COP was introduced as an assessment in 2012, calculating the value from tests prior to that date was possible because those tests had captured the relevant breathing rate and oxygen uptake. In males aged 18-85 years, a worse COP was significantly associated with an increased risk for earlier death. This finding did not hold for females, however; Dr. Araújo noted that more research is needed to understand the discrepancy in COP’s predictive power by sex.
In the heart failure study, everyone enrolled had heart failure and completed a COP test. People with the worse COPs also had the worst symptoms of heart failure, but completing an exercise rehabilitation program improved COP values when researchers measured them again. Dr. Araújo was also part of this study, based in the Netherlands.
“I think the COP could become a novel parameter in clinical care,” for most people, said Thijs Eijsvogels, PhD, an exercise physiologist at Radboud University in Nijmegen, the Netherlands, and the senior author of the heart failure study. That said, Dr. Eijsvogels said elite athletes will always be more interested in measuring VO2 max.
Dr. Lala agreed that tests such as the COP have some value. Her own work has shown that measuring the efficiency of someone’s breathing patterns for exhaling carbon dioxide, which can also be done without making people exercise full strength, has prognostic value for patients with advanced heart failure. Even so, she said she would like to see maximal effort tests used as much as possible.
“I worry about saying we’re going to settle for a parameter that can be achieved at 50% of peak VO2 and then we don’t exercise our patients,” Dr. Lala said.
Dr. Araújo said he plans to continue to measure VO2 max but he believes COP has utility – even for elite athletes. One of his patients is a frequent Ironman competitor who competes well despite having a solid but not amazing VO2 max level. But her COP is quite low, Dr. Araújo said, which to him suggests an especially efficient interaction between her respiratory and cardiovascular systems.
“We have a new player in the game,” Dr. Araújo said.
The sources in this study report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to clinicians who champion the assessment. The COP is easier to obtain than cardiorespiratory measures that require people to exercise to their limit, advocates say; rather than running full speed, someone can walk or lightly jog on a treadmill, with a COP value obtained easily.
But other clinicians argue that maximal exercise tests have many prognostic benefits, and that physicians should do everything in their power to push patients to exercise as hard as possible. In particular, the VO2 max test captures the maximum amount of oxygen someone uses when exercising at their capacity and is the preferred method for measuring cardiovascular endurance.
The COP is a measure of the minimum number of liters of air during breathing required to move one liter of oxygen through the bloodstream. The lower the COP the better, because this means that someone is working less strenuously than someone else to transport the same amount of oxygen, denoting a more efficient interaction between their heart and lungs.
The COP for a fit person might be 15, about 20-25 for a healthy person, and 35 for someone with heart failure, according to Claudio Gil Araújo, MD, PhD, director of research and education at CLINIMEX, an exercise medicine clinic in Rio de Janeiro.
“Max VO2 is very important, that’s indisputable. But when do you use max VO2 in your daily life? Never,” Dr. Araújo said. But almost anyone can generate a COP.
Emerging uses for the COP
“I can put someone on the treadmill or bike, and after 3 or 4 minutes I have the COP. It’s like a walking pace,” Dr. Araújo said. Yet the values are obtained with roughly half the effort as VO2 max. Other clinicians argue exercising to the limits of endurance offers unique clinical insights.
“We should do everything in our power to exercise our patients to maximum. How long a patient is able to go is really important,” said Anu Lala, MD, a cardiologist who specializes in heart failure treatment at Mount Sinai Hospital in New York. A full-capacity exercise test gives useful insights into someone’s heart rate, heart rate recovery, blood pressure, and ECG response to vigorous exercise, Dr. Lala added, all of which are important clues to someone’s overall health.
In 2012 Dr. Araújo coauthored a study that first defined the COP, which is calculated by measuring expired gasses people produce while gently exercising, perhaps to the point where they begin to perspire, and then dividing their breathing capacity by their oxygen uptake every minute. The lowest value obtained during any exercise session is the COP.
Various studies show that higher COP values are associated with more severe heart lesions in patients with congenital heart disease; higher levels of mortality in seemingly healthy male adults; and with worse prognoses in patients with heart failure. These studies all appeared within the last 7 months.
The mortality study, which Dr. Araújo coauthored, compared COP in more than 3,000 U.S. men and women who completed an exercise test from 1973 to 2018 and were tracked for an average of 23 years. Although COP was introduced as an assessment in 2012, calculating the value from tests prior to that date was possible because those tests had captured the relevant breathing rate and oxygen uptake. In males aged 18-85 years, a worse COP was significantly associated with an increased risk for earlier death. This finding did not hold for females, however; Dr. Araújo noted that more research is needed to understand the discrepancy in COP’s predictive power by sex.
In the heart failure study, everyone enrolled had heart failure and completed a COP test. People with the worse COPs also had the worst symptoms of heart failure, but completing an exercise rehabilitation program improved COP values when researchers measured them again. Dr. Araújo was also part of this study, based in the Netherlands.
“I think the COP could become a novel parameter in clinical care,” for most people, said Thijs Eijsvogels, PhD, an exercise physiologist at Radboud University in Nijmegen, the Netherlands, and the senior author of the heart failure study. That said, Dr. Eijsvogels said elite athletes will always be more interested in measuring VO2 max.
Dr. Lala agreed that tests such as the COP have some value. Her own work has shown that measuring the efficiency of someone’s breathing patterns for exhaling carbon dioxide, which can also be done without making people exercise full strength, has prognostic value for patients with advanced heart failure. Even so, she said she would like to see maximal effort tests used as much as possible.
“I worry about saying we’re going to settle for a parameter that can be achieved at 50% of peak VO2 and then we don’t exercise our patients,” Dr. Lala said.
Dr. Araújo said he plans to continue to measure VO2 max but he believes COP has utility – even for elite athletes. One of his patients is a frequent Ironman competitor who competes well despite having a solid but not amazing VO2 max level. But her COP is quite low, Dr. Araújo said, which to him suggests an especially efficient interaction between her respiratory and cardiovascular systems.
“We have a new player in the game,” Dr. Araújo said.
The sources in this study report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to clinicians who champion the assessment. The COP is easier to obtain than cardiorespiratory measures that require people to exercise to their limit, advocates say; rather than running full speed, someone can walk or lightly jog on a treadmill, with a COP value obtained easily.
But other clinicians argue that maximal exercise tests have many prognostic benefits, and that physicians should do everything in their power to push patients to exercise as hard as possible. In particular, the VO2 max test captures the maximum amount of oxygen someone uses when exercising at their capacity and is the preferred method for measuring cardiovascular endurance.
The COP is a measure of the minimum number of liters of air during breathing required to move one liter of oxygen through the bloodstream. The lower the COP the better, because this means that someone is working less strenuously than someone else to transport the same amount of oxygen, denoting a more efficient interaction between their heart and lungs.
The COP for a fit person might be 15, about 20-25 for a healthy person, and 35 for someone with heart failure, according to Claudio Gil Araújo, MD, PhD, director of research and education at CLINIMEX, an exercise medicine clinic in Rio de Janeiro.
“Max VO2 is very important, that’s indisputable. But when do you use max VO2 in your daily life? Never,” Dr. Araújo said. But almost anyone can generate a COP.
Emerging uses for the COP
“I can put someone on the treadmill or bike, and after 3 or 4 minutes I have the COP. It’s like a walking pace,” Dr. Araújo said. Yet the values are obtained with roughly half the effort as VO2 max. Other clinicians argue exercising to the limits of endurance offers unique clinical insights.
“We should do everything in our power to exercise our patients to maximum. How long a patient is able to go is really important,” said Anu Lala, MD, a cardiologist who specializes in heart failure treatment at Mount Sinai Hospital in New York. A full-capacity exercise test gives useful insights into someone’s heart rate, heart rate recovery, blood pressure, and ECG response to vigorous exercise, Dr. Lala added, all of which are important clues to someone’s overall health.
In 2012 Dr. Araújo coauthored a study that first defined the COP, which is calculated by measuring expired gasses people produce while gently exercising, perhaps to the point where they begin to perspire, and then dividing their breathing capacity by their oxygen uptake every minute. The lowest value obtained during any exercise session is the COP.
Various studies show that higher COP values are associated with more severe heart lesions in patients with congenital heart disease; higher levels of mortality in seemingly healthy male adults; and with worse prognoses in patients with heart failure. These studies all appeared within the last 7 months.
The mortality study, which Dr. Araújo coauthored, compared COP in more than 3,000 U.S. men and women who completed an exercise test from 1973 to 2018 and were tracked for an average of 23 years. Although COP was introduced as an assessment in 2012, calculating the value from tests prior to that date was possible because those tests had captured the relevant breathing rate and oxygen uptake. In males aged 18-85 years, a worse COP was significantly associated with an increased risk for earlier death. This finding did not hold for females, however; Dr. Araújo noted that more research is needed to understand the discrepancy in COP’s predictive power by sex.
In the heart failure study, everyone enrolled had heart failure and completed a COP test. People with the worse COPs also had the worst symptoms of heart failure, but completing an exercise rehabilitation program improved COP values when researchers measured them again. Dr. Araújo was also part of this study, based in the Netherlands.
“I think the COP could become a novel parameter in clinical care,” for most people, said Thijs Eijsvogels, PhD, an exercise physiologist at Radboud University in Nijmegen, the Netherlands, and the senior author of the heart failure study. That said, Dr. Eijsvogels said elite athletes will always be more interested in measuring VO2 max.
Dr. Lala agreed that tests such as the COP have some value. Her own work has shown that measuring the efficiency of someone’s breathing patterns for exhaling carbon dioxide, which can also be done without making people exercise full strength, has prognostic value for patients with advanced heart failure. Even so, she said she would like to see maximal effort tests used as much as possible.
“I worry about saying we’re going to settle for a parameter that can be achieved at 50% of peak VO2 and then we don’t exercise our patients,” Dr. Lala said.
Dr. Araújo said he plans to continue to measure VO2 max but he believes COP has utility – even for elite athletes. One of his patients is a frequent Ironman competitor who competes well despite having a solid but not amazing VO2 max level. But her COP is quite low, Dr. Araújo said, which to him suggests an especially efficient interaction between her respiratory and cardiovascular systems.
“We have a new player in the game,” Dr. Araújo said.
The sources in this study report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Low-dose oral minoxidil for hair loss soars after NYT article
.
The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.
The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.
Rodney Sinclair, MD, professor of dermatology at the University of Melbourne, who conducted the original research on LDOM and hair loss and was quoted in the Times story, told this news organization that “the sharp uplift after the New York Times article was on the back of a gradual increase.” He added that “the momentum for minoxidil prescriptions is increasing,” so much so that it has led to a global shortage of LDOM. The drug appears to still be widely available in the United States, however. It is not on the ASHP shortages list.
“There has been growing momentum for minoxidil use since I first presented our data about 6 years ago,” Dr. Sinclair said. He noted that 2022 International Society of Hair Restoration Surgery survey data found that 26% of treating physicians always or often prescribed off-label oral minoxidil, up from 10% in 2019 and 0% in 2017, while another 20% said they prescribed it sometimes.
The authors of the new study looked at prescriptions for patients at eight health care systems before and after the Times article was published in August 2022. They calculated the rate of first-time oral minoxidil prescriptions for 2.5 mg and 5 mg tablets, excluding 10 mg tablets, which are prescribed for hypertension.
Among those receiving first-time prescriptions, 2,846 received them in the 7 months before the article and 3,695 in the 5 months after publication. Men (43.6% after vs. 37.7% before publication) and White individuals (68.6% after vs. 60.8% before publication) accounted for a higher proportion of prescriptions after the article was published. There was a 2.4-fold increase in first-time prescriptions among men, and a 1.7-fold increase among females, while people with comorbidities accounted for a smaller proportion after the publication.
“Socioeconomic factors, such as access to health care and education and income levels, may be associated with individuals seeking low-dose oral minoxidil after article publication,” wrote the authors.
In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.
He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.
The results are expected to published soon in the Journal of Drugs in Dermatology.
“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.
That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.
“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”
However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.
Both he and Dr. Sinclair expect demand for LDOM to continue increasing.
“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.
Dr. Sinclair and Dr. Friedman report no relevant financial relationships.
.
The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.
The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.
Rodney Sinclair, MD, professor of dermatology at the University of Melbourne, who conducted the original research on LDOM and hair loss and was quoted in the Times story, told this news organization that “the sharp uplift after the New York Times article was on the back of a gradual increase.” He added that “the momentum for minoxidil prescriptions is increasing,” so much so that it has led to a global shortage of LDOM. The drug appears to still be widely available in the United States, however. It is not on the ASHP shortages list.
“There has been growing momentum for minoxidil use since I first presented our data about 6 years ago,” Dr. Sinclair said. He noted that 2022 International Society of Hair Restoration Surgery survey data found that 26% of treating physicians always or often prescribed off-label oral minoxidil, up from 10% in 2019 and 0% in 2017, while another 20% said they prescribed it sometimes.
The authors of the new study looked at prescriptions for patients at eight health care systems before and after the Times article was published in August 2022. They calculated the rate of first-time oral minoxidil prescriptions for 2.5 mg and 5 mg tablets, excluding 10 mg tablets, which are prescribed for hypertension.
Among those receiving first-time prescriptions, 2,846 received them in the 7 months before the article and 3,695 in the 5 months after publication. Men (43.6% after vs. 37.7% before publication) and White individuals (68.6% after vs. 60.8% before publication) accounted for a higher proportion of prescriptions after the article was published. There was a 2.4-fold increase in first-time prescriptions among men, and a 1.7-fold increase among females, while people with comorbidities accounted for a smaller proportion after the publication.
“Socioeconomic factors, such as access to health care and education and income levels, may be associated with individuals seeking low-dose oral minoxidil after article publication,” wrote the authors.
In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.
He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.
The results are expected to published soon in the Journal of Drugs in Dermatology.
“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.
That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.
“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”
However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.
Both he and Dr. Sinclair expect demand for LDOM to continue increasing.
“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.
Dr. Sinclair and Dr. Friedman report no relevant financial relationships.
.
The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.
The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.
Rodney Sinclair, MD, professor of dermatology at the University of Melbourne, who conducted the original research on LDOM and hair loss and was quoted in the Times story, told this news organization that “the sharp uplift after the New York Times article was on the back of a gradual increase.” He added that “the momentum for minoxidil prescriptions is increasing,” so much so that it has led to a global shortage of LDOM. The drug appears to still be widely available in the United States, however. It is not on the ASHP shortages list.
“There has been growing momentum for minoxidil use since I first presented our data about 6 years ago,” Dr. Sinclair said. He noted that 2022 International Society of Hair Restoration Surgery survey data found that 26% of treating physicians always or often prescribed off-label oral minoxidil, up from 10% in 2019 and 0% in 2017, while another 20% said they prescribed it sometimes.
The authors of the new study looked at prescriptions for patients at eight health care systems before and after the Times article was published in August 2022. They calculated the rate of first-time oral minoxidil prescriptions for 2.5 mg and 5 mg tablets, excluding 10 mg tablets, which are prescribed for hypertension.
Among those receiving first-time prescriptions, 2,846 received them in the 7 months before the article and 3,695 in the 5 months after publication. Men (43.6% after vs. 37.7% before publication) and White individuals (68.6% after vs. 60.8% before publication) accounted for a higher proportion of prescriptions after the article was published. There was a 2.4-fold increase in first-time prescriptions among men, and a 1.7-fold increase among females, while people with comorbidities accounted for a smaller proportion after the publication.
“Socioeconomic factors, such as access to health care and education and income levels, may be associated with individuals seeking low-dose oral minoxidil after article publication,” wrote the authors.
In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.
He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.
The results are expected to published soon in the Journal of Drugs in Dermatology.
“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.
That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.
“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”
However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.
Both he and Dr. Sinclair expect demand for LDOM to continue increasing.
“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.
Dr. Sinclair and Dr. Friedman report no relevant financial relationships.
FROM JAMA NETWORK OPEN
Cuffless blood pressure monitors: Still a numbers game
Medscape’s Editor-in-Chief Eric Topol, MD, referred to continual noninvasive, cuffless, accurate blood pressure devices as “a holy grail in sensor technology.”
He personally tested a cuff-calibrated, over-the-counter device available in Europe that claims to monitor daily blood pressure changes and produce data that can help physicians titrate medications.
Dr. Topol does not believe that it is ready for prime time. Yes, cuffless devices are easy to use, and generate lots of data. But are those data accurate?
Many experts say not yet, even as the market continues to grow and more devices are introduced and highlighted at high-profile consumer events.
Burned before
Limitations of cuffed devices are well known, including errors related to cuff size, patient positioning, patient habits or behaviors (for example, caffeine/nicotine use, acute meal digestion, full bladder, very recent physical activity) and clinicians’ failure to take accurate measurements.
Like many clinicians, Timothy B. Plante, MD, MHS, assistant professor at the University of Vermont Medical Center thrombosis & hemostasis program in Burlington, is very excited about cuffless technology. However, “we’ve been burned by it before,” he said in an interview.
Dr. Plante’s 2016 validation study of an instant blood pressure smartphone app found that its measurements were “highly inaccurate,” with such low sensitivity that more than three-quarters of individuals with hypertensive blood levels would be falsely reassured that their blood pressure was in the normal range.
His team’s 2023 review of the current landscape, which includes more sophisticated devices, concluded that accuracy remains an issue: “Unfortunately, the pace of regulation of these devices has failed to match the speed of innovation and direct availability to patient consumers. There is an urgent need to develop a consensus on standards by which cuffless BP devices can be tested for accuracy.”
Devices, indications differ
Cuffless devices estimate blood pressure indirectly. Most operate based on pulse wave analysis and pulse arrival time (PWA-PAT), explained Ramakrishna Mukkamala, PhD, in a commentary. Dr. Mukkamala is a professor in the departments of bioengineering and anesthesiology and perioperative medicine at the University of Pittsburgh.
PWA involves measuring a peripheral arterial waveform using an optical sensor such as the green lights on the back of a wrist-worn device, or a ‘force sensor’ such as a finger cuff or pressing on a smartphone. Certain features are extracted from the waveform using machine learning and calibrated to blood pressure values.
PAT techniques work together with PWA; they record the ECG and extract features from that signal as well as the arterial waveform for calibration to blood pressure values.
The algorithm used to generate the BP numbers comprises a proprietary baseline model that may include demographics and other patient characteristics. A cuff measurement is often part of the baseline model because most cuffless devices require periodic (typically weekly or monthly) calibration using a cuffed device.
Cuffless devices that require cuff calibration compare the estimate they get to the cuff-calibrated number. In this scenario, the cuffless device may come up with the same blood pressure numbers simply because the baseline model – which is made up of thousands of data points relevant to the patient – has not changed.
This has led some experts to question whether PWA-PAT cuffless device readings actually add anything to the baseline model.
They don’t, according to Microsoft Research in what Dr. Mukkamala and coauthors referred to (in a review published in Hypertension) as “a complex article describing perhaps the most important and highest resource project to date (Aurora Project) on assessing the accuracy of PWA and PWA devices.”
The Microsoft article was written for bioengineers. The review in Hypertension explains the project for clinicians, and concludes that, “Cuffless BP devices based on PWA and PWA-PAT, which are similar to some regulatory-cleared devices, were of no additional value in measuring auscultatory or 24-hour ambulatory cuff BP when compared with a baseline model in which BP was predicted without an actual measurement.”
IEEE and FDA validation
Despite these concerns, several cuffless devices using PWA and PAT have been cleared by the Food and Drug Administration.
Validating cuffless devices is no simple matter. The Institute of Electrical and Electronics Engineers published a validation protocol for cuffless blood pressure devices in 2014 that was amended in 2019 to include a requirement to evaluate performance in different positions and in the presence of motion with varying degrees of noise artifact.
However, Daichi Shimbo, MD, codirector of the Columbia Hypertension Center in New York and vice chair of the American Heart Association Statement on blood pressure monitoring, and colleagues point out limitations, even in the updated standard. These include not requiring evaluation for drift over time; lack of specific dynamic testing protocols for stressors such as exercise or environmental temperatures; and an unsuitable reference standard (oscillometric cuff-based devices) during movement.
Dr. Shimbo said in an interview that, although he is excited about them, “these cuffless devices are not aligned with regulatory bodies. If a device gives someone a wrong blood pressure, they might be diagnosed with hypertension when they don’t have it or might miss the fact that they’re hypertensive because they get a normal blood pressure reading. If there’s no yardstick by which you say these devices are good, what are we really doing – helping, or causing a problem?”
“The specifics of how a device estimates blood pressure can determine what testing is needed to ensure that it is providing accurate performance in the intended conditions of use,” Jeremy Kahn, an FDA press officer, said in an interview. “For example, for cuffless devices that are calibrated initially with a cuff-based blood pressure device, the cuffless device needs to specify the period over which it can provide accurate readings and have testing to demonstrate that it provides accurate results over that period of use.”
The FDA said its testing is different from what the Microsoft Aurora Project used in their study.
“The intent of that testing, as the agency understands it, is to evaluate whether the device is providing useful input based on the current physiology of the patient rather than relying on predetermined values based on calibration or patient attributes. We evaluate this clinically in two separate tests: an induced change in blood pressure test and tracking of natural blood pressure changes with longer term device use,” Mr. Kahn explained.
Analyzing a device’s performance on individuals who have had natural changes in blood pressure as compared to a calibration value or initial reading “can also help discern if the device is using physiological data from the patient to determine their blood pressure accurately,” he said.
Experts interviewed for this article who remain skeptical about cuffless BP monitoring question whether the numbers that appear during the induced blood pressure change, and with the natural blood pressure changes that may occur over time, accurately reflect a patient’s blood pressure.
“The FDA doesn’t approve these devices; they clear them,” Dr. Shimbo pointed out. “Clearing them means they can be sold to the general public in the U.S. It’s not a strong statement that they’re accurate.”
Moving toward validation, standards
Ultimately, cuffless BP monitors may require more than one validation protocol and standard, depending on their technology, how and where they will be used, and by whom.
And as Dr. Plante and colleagues write, “Importantly, validation should be performed in diverse and special populations, including pregnant women and individuals across a range of heart rates, skin tones, wrist sizes, common arrhythmias, and beta-blocker use.”
Organizations that might be expected to help move validation and standards forward have mostly remained silent. The American Medical Association’s US Blood Pressure Validated Device Listing website includes only cuffed devices, as does the website of the international scientific nonprofit STRIDE BP.
The European Society of Hypertension 2022 consensus statement on cuffless devices concluded that, until there is an internationally accepted accuracy standard and the devices have been tested in healthy people and those with suspected or diagnosed hypertension, “cuffless BP devices should not be used for the evaluation or management of hypertension in clinical practice.”
This month, ESH published recommendations for “specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices” that will be presented at their upcoming annual meeting June 26.
Updated protocols from IEEE “are coming out soon,” according to Dr. Shimbo. The FDA says currently cleared devices won’t need to revalidate according to new standards unless the sponsor makes significant modifications in software algorithms, device hardware, or targeted patient populations.
Device makers take the initiative
In the face of conflicting reports on accuracy and lack of a robust standard, some device makers are publishing their own tests or encouraging validation by potential customers.
For example, institutions that are considering using the Biobeat cuffless blood pressure monitor watch “usually start with small pilots with our devices to do internal validation,” Lior Ben Shettrit, the company’s vice president of business development, said in an interview. “Only after they complete the internal validation are they willing to move forward to full implementation.”
Cardiologist Dean Nachman, MD, is leading validation studies of the Biobeat device at the Hadassah Ein Kerem Medical Center in Jerusalem. For the first validation, the team recruited 1,057 volunteers who did a single blood pressure measurement with the cuffless device and with a cuffed device.
“We found 96.3% agreement in identifying hypertension and an interclass correlation coefficient of 0.99 and 0.97 for systolic and diastolic measurements, respectively,” he said. “Then we took it to the next level and compared the device to ambulatory 24-hour blood pressure monitoring and found comparable measurements.”
The investigators are not done yet. “We need data from thousands of patients, with subgroups, to not have any concerns,” he says. “Right now, we are using the device as a general monitor – as an EKG plus heart rate plus oxygen saturation level monitor – and as a blood pressure monitor for 24-hour blood pressure monitoring.”
The developers of the Aktiia device, which is the one Dr. Topol tested, take a different perspective. “When somebody introduces a new technology that is disrupting something that has been in place for over 100 years, there will always be some grumblings, ruffling of feathers, people saying it’s not ready, it’s not ready, it’s not ready,” Aktiia’s chief medical officer Jay Shah, MD, noted.
“But a lot of those comments are coming from the isolation of an ivory tower,” he said.
Aktiia cofounder and chief technology officer Josep Solà said that “no device is probably as accurate as if you have an invasive catheter,” adding that “we engage patients to look at their blood pressure day by day. … If each individual measurement of each of those patient is slightly less accurate than a cuff, who cares? We have 40 measurements per day on each patient. The accuracy and precision of each of those is good.”
Researchers from the George Institute for Global Health recently compared the Aktiia device to conventional ambulatory monitoring in 41 patients and found that “it did not accurately track night-time BP decline and results suggested it was unable to track medication-induced BP changes.”
“In the context of 24/7 monitoring of hypertensive patients,” Mr. Solà said, “whatever you do, if it’s better than a sham device or a baseline model and you track the blood pressure changes, it’s a hundred times much better than doing nothing.”
Dr. Nachman and Dr. Plante reported no relevant financial relationships. Dr. Shimbo reported that he received funding from NIH and has consulted for Abbott Vascular, Edward Lifesciences, Medtronic, and Tryton Medical.
A version of this article first appeared on Medscape.com.
Medscape’s Editor-in-Chief Eric Topol, MD, referred to continual noninvasive, cuffless, accurate blood pressure devices as “a holy grail in sensor technology.”
He personally tested a cuff-calibrated, over-the-counter device available in Europe that claims to monitor daily blood pressure changes and produce data that can help physicians titrate medications.
Dr. Topol does not believe that it is ready for prime time. Yes, cuffless devices are easy to use, and generate lots of data. But are those data accurate?
Many experts say not yet, even as the market continues to grow and more devices are introduced and highlighted at high-profile consumer events.
Burned before
Limitations of cuffed devices are well known, including errors related to cuff size, patient positioning, patient habits or behaviors (for example, caffeine/nicotine use, acute meal digestion, full bladder, very recent physical activity) and clinicians’ failure to take accurate measurements.
Like many clinicians, Timothy B. Plante, MD, MHS, assistant professor at the University of Vermont Medical Center thrombosis & hemostasis program in Burlington, is very excited about cuffless technology. However, “we’ve been burned by it before,” he said in an interview.
Dr. Plante’s 2016 validation study of an instant blood pressure smartphone app found that its measurements were “highly inaccurate,” with such low sensitivity that more than three-quarters of individuals with hypertensive blood levels would be falsely reassured that their blood pressure was in the normal range.
His team’s 2023 review of the current landscape, which includes more sophisticated devices, concluded that accuracy remains an issue: “Unfortunately, the pace of regulation of these devices has failed to match the speed of innovation and direct availability to patient consumers. There is an urgent need to develop a consensus on standards by which cuffless BP devices can be tested for accuracy.”
Devices, indications differ
Cuffless devices estimate blood pressure indirectly. Most operate based on pulse wave analysis and pulse arrival time (PWA-PAT), explained Ramakrishna Mukkamala, PhD, in a commentary. Dr. Mukkamala is a professor in the departments of bioengineering and anesthesiology and perioperative medicine at the University of Pittsburgh.
PWA involves measuring a peripheral arterial waveform using an optical sensor such as the green lights on the back of a wrist-worn device, or a ‘force sensor’ such as a finger cuff or pressing on a smartphone. Certain features are extracted from the waveform using machine learning and calibrated to blood pressure values.
PAT techniques work together with PWA; they record the ECG and extract features from that signal as well as the arterial waveform for calibration to blood pressure values.
The algorithm used to generate the BP numbers comprises a proprietary baseline model that may include demographics and other patient characteristics. A cuff measurement is often part of the baseline model because most cuffless devices require periodic (typically weekly or monthly) calibration using a cuffed device.
Cuffless devices that require cuff calibration compare the estimate they get to the cuff-calibrated number. In this scenario, the cuffless device may come up with the same blood pressure numbers simply because the baseline model – which is made up of thousands of data points relevant to the patient – has not changed.
This has led some experts to question whether PWA-PAT cuffless device readings actually add anything to the baseline model.
They don’t, according to Microsoft Research in what Dr. Mukkamala and coauthors referred to (in a review published in Hypertension) as “a complex article describing perhaps the most important and highest resource project to date (Aurora Project) on assessing the accuracy of PWA and PWA devices.”
The Microsoft article was written for bioengineers. The review in Hypertension explains the project for clinicians, and concludes that, “Cuffless BP devices based on PWA and PWA-PAT, which are similar to some regulatory-cleared devices, were of no additional value in measuring auscultatory or 24-hour ambulatory cuff BP when compared with a baseline model in which BP was predicted without an actual measurement.”
IEEE and FDA validation
Despite these concerns, several cuffless devices using PWA and PAT have been cleared by the Food and Drug Administration.
Validating cuffless devices is no simple matter. The Institute of Electrical and Electronics Engineers published a validation protocol for cuffless blood pressure devices in 2014 that was amended in 2019 to include a requirement to evaluate performance in different positions and in the presence of motion with varying degrees of noise artifact.
However, Daichi Shimbo, MD, codirector of the Columbia Hypertension Center in New York and vice chair of the American Heart Association Statement on blood pressure monitoring, and colleagues point out limitations, even in the updated standard. These include not requiring evaluation for drift over time; lack of specific dynamic testing protocols for stressors such as exercise or environmental temperatures; and an unsuitable reference standard (oscillometric cuff-based devices) during movement.
Dr. Shimbo said in an interview that, although he is excited about them, “these cuffless devices are not aligned with regulatory bodies. If a device gives someone a wrong blood pressure, they might be diagnosed with hypertension when they don’t have it or might miss the fact that they’re hypertensive because they get a normal blood pressure reading. If there’s no yardstick by which you say these devices are good, what are we really doing – helping, or causing a problem?”
“The specifics of how a device estimates blood pressure can determine what testing is needed to ensure that it is providing accurate performance in the intended conditions of use,” Jeremy Kahn, an FDA press officer, said in an interview. “For example, for cuffless devices that are calibrated initially with a cuff-based blood pressure device, the cuffless device needs to specify the period over which it can provide accurate readings and have testing to demonstrate that it provides accurate results over that period of use.”
The FDA said its testing is different from what the Microsoft Aurora Project used in their study.
“The intent of that testing, as the agency understands it, is to evaluate whether the device is providing useful input based on the current physiology of the patient rather than relying on predetermined values based on calibration or patient attributes. We evaluate this clinically in two separate tests: an induced change in blood pressure test and tracking of natural blood pressure changes with longer term device use,” Mr. Kahn explained.
Analyzing a device’s performance on individuals who have had natural changes in blood pressure as compared to a calibration value or initial reading “can also help discern if the device is using physiological data from the patient to determine their blood pressure accurately,” he said.
Experts interviewed for this article who remain skeptical about cuffless BP monitoring question whether the numbers that appear during the induced blood pressure change, and with the natural blood pressure changes that may occur over time, accurately reflect a patient’s blood pressure.
“The FDA doesn’t approve these devices; they clear them,” Dr. Shimbo pointed out. “Clearing them means they can be sold to the general public in the U.S. It’s not a strong statement that they’re accurate.”
Moving toward validation, standards
Ultimately, cuffless BP monitors may require more than one validation protocol and standard, depending on their technology, how and where they will be used, and by whom.
And as Dr. Plante and colleagues write, “Importantly, validation should be performed in diverse and special populations, including pregnant women and individuals across a range of heart rates, skin tones, wrist sizes, common arrhythmias, and beta-blocker use.”
Organizations that might be expected to help move validation and standards forward have mostly remained silent. The American Medical Association’s US Blood Pressure Validated Device Listing website includes only cuffed devices, as does the website of the international scientific nonprofit STRIDE BP.
The European Society of Hypertension 2022 consensus statement on cuffless devices concluded that, until there is an internationally accepted accuracy standard and the devices have been tested in healthy people and those with suspected or diagnosed hypertension, “cuffless BP devices should not be used for the evaluation or management of hypertension in clinical practice.”
This month, ESH published recommendations for “specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices” that will be presented at their upcoming annual meeting June 26.
Updated protocols from IEEE “are coming out soon,” according to Dr. Shimbo. The FDA says currently cleared devices won’t need to revalidate according to new standards unless the sponsor makes significant modifications in software algorithms, device hardware, or targeted patient populations.
Device makers take the initiative
In the face of conflicting reports on accuracy and lack of a robust standard, some device makers are publishing their own tests or encouraging validation by potential customers.
For example, institutions that are considering using the Biobeat cuffless blood pressure monitor watch “usually start with small pilots with our devices to do internal validation,” Lior Ben Shettrit, the company’s vice president of business development, said in an interview. “Only after they complete the internal validation are they willing to move forward to full implementation.”
Cardiologist Dean Nachman, MD, is leading validation studies of the Biobeat device at the Hadassah Ein Kerem Medical Center in Jerusalem. For the first validation, the team recruited 1,057 volunteers who did a single blood pressure measurement with the cuffless device and with a cuffed device.
“We found 96.3% agreement in identifying hypertension and an interclass correlation coefficient of 0.99 and 0.97 for systolic and diastolic measurements, respectively,” he said. “Then we took it to the next level and compared the device to ambulatory 24-hour blood pressure monitoring and found comparable measurements.”
The investigators are not done yet. “We need data from thousands of patients, with subgroups, to not have any concerns,” he says. “Right now, we are using the device as a general monitor – as an EKG plus heart rate plus oxygen saturation level monitor – and as a blood pressure monitor for 24-hour blood pressure monitoring.”
The developers of the Aktiia device, which is the one Dr. Topol tested, take a different perspective. “When somebody introduces a new technology that is disrupting something that has been in place for over 100 years, there will always be some grumblings, ruffling of feathers, people saying it’s not ready, it’s not ready, it’s not ready,” Aktiia’s chief medical officer Jay Shah, MD, noted.
“But a lot of those comments are coming from the isolation of an ivory tower,” he said.
Aktiia cofounder and chief technology officer Josep Solà said that “no device is probably as accurate as if you have an invasive catheter,” adding that “we engage patients to look at their blood pressure day by day. … If each individual measurement of each of those patient is slightly less accurate than a cuff, who cares? We have 40 measurements per day on each patient. The accuracy and precision of each of those is good.”
Researchers from the George Institute for Global Health recently compared the Aktiia device to conventional ambulatory monitoring in 41 patients and found that “it did not accurately track night-time BP decline and results suggested it was unable to track medication-induced BP changes.”
“In the context of 24/7 monitoring of hypertensive patients,” Mr. Solà said, “whatever you do, if it’s better than a sham device or a baseline model and you track the blood pressure changes, it’s a hundred times much better than doing nothing.”
Dr. Nachman and Dr. Plante reported no relevant financial relationships. Dr. Shimbo reported that he received funding from NIH and has consulted for Abbott Vascular, Edward Lifesciences, Medtronic, and Tryton Medical.
A version of this article first appeared on Medscape.com.
Medscape’s Editor-in-Chief Eric Topol, MD, referred to continual noninvasive, cuffless, accurate blood pressure devices as “a holy grail in sensor technology.”
He personally tested a cuff-calibrated, over-the-counter device available in Europe that claims to monitor daily blood pressure changes and produce data that can help physicians titrate medications.
Dr. Topol does not believe that it is ready for prime time. Yes, cuffless devices are easy to use, and generate lots of data. But are those data accurate?
Many experts say not yet, even as the market continues to grow and more devices are introduced and highlighted at high-profile consumer events.
Burned before
Limitations of cuffed devices are well known, including errors related to cuff size, patient positioning, patient habits or behaviors (for example, caffeine/nicotine use, acute meal digestion, full bladder, very recent physical activity) and clinicians’ failure to take accurate measurements.
Like many clinicians, Timothy B. Plante, MD, MHS, assistant professor at the University of Vermont Medical Center thrombosis & hemostasis program in Burlington, is very excited about cuffless technology. However, “we’ve been burned by it before,” he said in an interview.
Dr. Plante’s 2016 validation study of an instant blood pressure smartphone app found that its measurements were “highly inaccurate,” with such low sensitivity that more than three-quarters of individuals with hypertensive blood levels would be falsely reassured that their blood pressure was in the normal range.
His team’s 2023 review of the current landscape, which includes more sophisticated devices, concluded that accuracy remains an issue: “Unfortunately, the pace of regulation of these devices has failed to match the speed of innovation and direct availability to patient consumers. There is an urgent need to develop a consensus on standards by which cuffless BP devices can be tested for accuracy.”
Devices, indications differ
Cuffless devices estimate blood pressure indirectly. Most operate based on pulse wave analysis and pulse arrival time (PWA-PAT), explained Ramakrishna Mukkamala, PhD, in a commentary. Dr. Mukkamala is a professor in the departments of bioengineering and anesthesiology and perioperative medicine at the University of Pittsburgh.
PWA involves measuring a peripheral arterial waveform using an optical sensor such as the green lights on the back of a wrist-worn device, or a ‘force sensor’ such as a finger cuff or pressing on a smartphone. Certain features are extracted from the waveform using machine learning and calibrated to blood pressure values.
PAT techniques work together with PWA; they record the ECG and extract features from that signal as well as the arterial waveform for calibration to blood pressure values.
The algorithm used to generate the BP numbers comprises a proprietary baseline model that may include demographics and other patient characteristics. A cuff measurement is often part of the baseline model because most cuffless devices require periodic (typically weekly or monthly) calibration using a cuffed device.
Cuffless devices that require cuff calibration compare the estimate they get to the cuff-calibrated number. In this scenario, the cuffless device may come up with the same blood pressure numbers simply because the baseline model – which is made up of thousands of data points relevant to the patient – has not changed.
This has led some experts to question whether PWA-PAT cuffless device readings actually add anything to the baseline model.
They don’t, according to Microsoft Research in what Dr. Mukkamala and coauthors referred to (in a review published in Hypertension) as “a complex article describing perhaps the most important and highest resource project to date (Aurora Project) on assessing the accuracy of PWA and PWA devices.”
The Microsoft article was written for bioengineers. The review in Hypertension explains the project for clinicians, and concludes that, “Cuffless BP devices based on PWA and PWA-PAT, which are similar to some regulatory-cleared devices, were of no additional value in measuring auscultatory or 24-hour ambulatory cuff BP when compared with a baseline model in which BP was predicted without an actual measurement.”
IEEE and FDA validation
Despite these concerns, several cuffless devices using PWA and PAT have been cleared by the Food and Drug Administration.
Validating cuffless devices is no simple matter. The Institute of Electrical and Electronics Engineers published a validation protocol for cuffless blood pressure devices in 2014 that was amended in 2019 to include a requirement to evaluate performance in different positions and in the presence of motion with varying degrees of noise artifact.
However, Daichi Shimbo, MD, codirector of the Columbia Hypertension Center in New York and vice chair of the American Heart Association Statement on blood pressure monitoring, and colleagues point out limitations, even in the updated standard. These include not requiring evaluation for drift over time; lack of specific dynamic testing protocols for stressors such as exercise or environmental temperatures; and an unsuitable reference standard (oscillometric cuff-based devices) during movement.
Dr. Shimbo said in an interview that, although he is excited about them, “these cuffless devices are not aligned with regulatory bodies. If a device gives someone a wrong blood pressure, they might be diagnosed with hypertension when they don’t have it or might miss the fact that they’re hypertensive because they get a normal blood pressure reading. If there’s no yardstick by which you say these devices are good, what are we really doing – helping, or causing a problem?”
“The specifics of how a device estimates blood pressure can determine what testing is needed to ensure that it is providing accurate performance in the intended conditions of use,” Jeremy Kahn, an FDA press officer, said in an interview. “For example, for cuffless devices that are calibrated initially with a cuff-based blood pressure device, the cuffless device needs to specify the period over which it can provide accurate readings and have testing to demonstrate that it provides accurate results over that period of use.”
The FDA said its testing is different from what the Microsoft Aurora Project used in their study.
“The intent of that testing, as the agency understands it, is to evaluate whether the device is providing useful input based on the current physiology of the patient rather than relying on predetermined values based on calibration or patient attributes. We evaluate this clinically in two separate tests: an induced change in blood pressure test and tracking of natural blood pressure changes with longer term device use,” Mr. Kahn explained.
Analyzing a device’s performance on individuals who have had natural changes in blood pressure as compared to a calibration value or initial reading “can also help discern if the device is using physiological data from the patient to determine their blood pressure accurately,” he said.
Experts interviewed for this article who remain skeptical about cuffless BP monitoring question whether the numbers that appear during the induced blood pressure change, and with the natural blood pressure changes that may occur over time, accurately reflect a patient’s blood pressure.
“The FDA doesn’t approve these devices; they clear them,” Dr. Shimbo pointed out. “Clearing them means they can be sold to the general public in the U.S. It’s not a strong statement that they’re accurate.”
Moving toward validation, standards
Ultimately, cuffless BP monitors may require more than one validation protocol and standard, depending on their technology, how and where they will be used, and by whom.
And as Dr. Plante and colleagues write, “Importantly, validation should be performed in diverse and special populations, including pregnant women and individuals across a range of heart rates, skin tones, wrist sizes, common arrhythmias, and beta-blocker use.”
Organizations that might be expected to help move validation and standards forward have mostly remained silent. The American Medical Association’s US Blood Pressure Validated Device Listing website includes only cuffed devices, as does the website of the international scientific nonprofit STRIDE BP.
The European Society of Hypertension 2022 consensus statement on cuffless devices concluded that, until there is an internationally accepted accuracy standard and the devices have been tested in healthy people and those with suspected or diagnosed hypertension, “cuffless BP devices should not be used for the evaluation or management of hypertension in clinical practice.”
This month, ESH published recommendations for “specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices” that will be presented at their upcoming annual meeting June 26.
Updated protocols from IEEE “are coming out soon,” according to Dr. Shimbo. The FDA says currently cleared devices won’t need to revalidate according to new standards unless the sponsor makes significant modifications in software algorithms, device hardware, or targeted patient populations.
Device makers take the initiative
In the face of conflicting reports on accuracy and lack of a robust standard, some device makers are publishing their own tests or encouraging validation by potential customers.
For example, institutions that are considering using the Biobeat cuffless blood pressure monitor watch “usually start with small pilots with our devices to do internal validation,” Lior Ben Shettrit, the company’s vice president of business development, said in an interview. “Only after they complete the internal validation are they willing to move forward to full implementation.”
Cardiologist Dean Nachman, MD, is leading validation studies of the Biobeat device at the Hadassah Ein Kerem Medical Center in Jerusalem. For the first validation, the team recruited 1,057 volunteers who did a single blood pressure measurement with the cuffless device and with a cuffed device.
“We found 96.3% agreement in identifying hypertension and an interclass correlation coefficient of 0.99 and 0.97 for systolic and diastolic measurements, respectively,” he said. “Then we took it to the next level and compared the device to ambulatory 24-hour blood pressure monitoring and found comparable measurements.”
The investigators are not done yet. “We need data from thousands of patients, with subgroups, to not have any concerns,” he says. “Right now, we are using the device as a general monitor – as an EKG plus heart rate plus oxygen saturation level monitor – and as a blood pressure monitor for 24-hour blood pressure monitoring.”
The developers of the Aktiia device, which is the one Dr. Topol tested, take a different perspective. “When somebody introduces a new technology that is disrupting something that has been in place for over 100 years, there will always be some grumblings, ruffling of feathers, people saying it’s not ready, it’s not ready, it’s not ready,” Aktiia’s chief medical officer Jay Shah, MD, noted.
“But a lot of those comments are coming from the isolation of an ivory tower,” he said.
Aktiia cofounder and chief technology officer Josep Solà said that “no device is probably as accurate as if you have an invasive catheter,” adding that “we engage patients to look at their blood pressure day by day. … If each individual measurement of each of those patient is slightly less accurate than a cuff, who cares? We have 40 measurements per day on each patient. The accuracy and precision of each of those is good.”
Researchers from the George Institute for Global Health recently compared the Aktiia device to conventional ambulatory monitoring in 41 patients and found that “it did not accurately track night-time BP decline and results suggested it was unable to track medication-induced BP changes.”
“In the context of 24/7 monitoring of hypertensive patients,” Mr. Solà said, “whatever you do, if it’s better than a sham device or a baseline model and you track the blood pressure changes, it’s a hundred times much better than doing nothing.”
Dr. Nachman and Dr. Plante reported no relevant financial relationships. Dr. Shimbo reported that he received funding from NIH and has consulted for Abbott Vascular, Edward Lifesciences, Medtronic, and Tryton Medical.
A version of this article first appeared on Medscape.com.
Early hysterectomy linked to higher CVD, stroke risk
TOPLINE:
METHODOLOGY:
- Risk of CVD rapidly increases after menopause, possibly owing to loss of protective effects of female sex hormones and hemorheologic changes.
- Results of previous studies of the association between hysterectomy and CVD were mixed.
- Using national health insurance data, this cohort study included 55,539 South Korean women (median age, 45 years) who underwent a hysterectomy and a propensity-matched group of women.
- The primary outcome was CVD, including myocardial infarction (MI), coronary artery revascularization, and stroke.
TAKEAWAY:
- During follow-up of just under 8 years, the hysterectomy group had an increased risk of CVD compared with the non-hysterectomy group (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.09-1.44; P = .002)
- The incidence of MI and coronary revascularization was comparable between groups, but the risk of stroke was significantly higher among those who had had a hysterectomy (HR, 1.31; 95% CI, 1.12-1.53; P < .001)
- This increase in risk was similar after excluding patients who also underwent adnexal surgery.
IN PRACTICE:
Early hysterectomy was linked to higher CVD risk, especially stroke, but since the CVD incidence wasn’t high, a change in clinical practice may not be needed, said the authors.
STUDY DETAILS:
The study was conducted by Jin-Sung Yuk, MD, PhD, Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea, and colleagues. It was published online June 12 in JAMA Network Open.
LIMITATIONS:
The study was retrospective and observational and used administrative databases that may be prone to inaccurate coding. The findings may not be generalizable outside Korea.
DISCLOSURES:
The study was supported by a National Research Foundation of Korea grant funded by the Korea government. The authors report no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Risk of CVD rapidly increases after menopause, possibly owing to loss of protective effects of female sex hormones and hemorheologic changes.
- Results of previous studies of the association between hysterectomy and CVD were mixed.
- Using national health insurance data, this cohort study included 55,539 South Korean women (median age, 45 years) who underwent a hysterectomy and a propensity-matched group of women.
- The primary outcome was CVD, including myocardial infarction (MI), coronary artery revascularization, and stroke.
TAKEAWAY:
- During follow-up of just under 8 years, the hysterectomy group had an increased risk of CVD compared with the non-hysterectomy group (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.09-1.44; P = .002)
- The incidence of MI and coronary revascularization was comparable between groups, but the risk of stroke was significantly higher among those who had had a hysterectomy (HR, 1.31; 95% CI, 1.12-1.53; P < .001)
- This increase in risk was similar after excluding patients who also underwent adnexal surgery.
IN PRACTICE:
Early hysterectomy was linked to higher CVD risk, especially stroke, but since the CVD incidence wasn’t high, a change in clinical practice may not be needed, said the authors.
STUDY DETAILS:
The study was conducted by Jin-Sung Yuk, MD, PhD, Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea, and colleagues. It was published online June 12 in JAMA Network Open.
LIMITATIONS:
The study was retrospective and observational and used administrative databases that may be prone to inaccurate coding. The findings may not be generalizable outside Korea.
DISCLOSURES:
The study was supported by a National Research Foundation of Korea grant funded by the Korea government. The authors report no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Risk of CVD rapidly increases after menopause, possibly owing to loss of protective effects of female sex hormones and hemorheologic changes.
- Results of previous studies of the association between hysterectomy and CVD were mixed.
- Using national health insurance data, this cohort study included 55,539 South Korean women (median age, 45 years) who underwent a hysterectomy and a propensity-matched group of women.
- The primary outcome was CVD, including myocardial infarction (MI), coronary artery revascularization, and stroke.
TAKEAWAY:
- During follow-up of just under 8 years, the hysterectomy group had an increased risk of CVD compared with the non-hysterectomy group (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.09-1.44; P = .002)
- The incidence of MI and coronary revascularization was comparable between groups, but the risk of stroke was significantly higher among those who had had a hysterectomy (HR, 1.31; 95% CI, 1.12-1.53; P < .001)
- This increase in risk was similar after excluding patients who also underwent adnexal surgery.
IN PRACTICE:
Early hysterectomy was linked to higher CVD risk, especially stroke, but since the CVD incidence wasn’t high, a change in clinical practice may not be needed, said the authors.
STUDY DETAILS:
The study was conducted by Jin-Sung Yuk, MD, PhD, Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea, and colleagues. It was published online June 12 in JAMA Network Open.
LIMITATIONS:
The study was retrospective and observational and used administrative databases that may be prone to inaccurate coding. The findings may not be generalizable outside Korea.
DISCLOSURES:
The study was supported by a National Research Foundation of Korea grant funded by the Korea government. The authors report no conflicts of interest.
A version of this article first appeared on Medscape.com.