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Is acetaminophen really safer than NSAIDs in heart disease?
New research calls into question the assumption that acetaminophen is safer than NSAIDs for patients with known cardiovascular disease (CVD) or CVD risk factors.
The analysis found a significant correlation between the use of acetaminophen and elevated systolic blood pressure.
While acetaminophen may still be safer than NSAIDs from a bleeding risk standpoint, or in patients with known kidney disease, “the gap may not be as large as once thought,” Rahul Gupta, MD, cardiologist with Lehigh Valley Health Network, Allentown, Pa., said in an interview.
“Cautious use is recommended over the long term, especially in patients with pre-existing hypertension or cardiovascular risk factors,” Dr. Gupta said.
The study was presented at the Hypertension Scientific Sessions, San Diego, sponsored by the American Heart Association.
Acetaminophen is one of the most widely used over-the-counter medications, as it is considered a safer medication for long-term use since it lacks the anti-inflammatory effects of NSAIDs, Dr. Gupta explained.
NSAIDs have been known to raise blood pressure, but the effect of acetaminophen in this regard has not been well studied. Observational studies have shown contradictory results in terms of its effect on blood pressure, he noted.
To investigate further, Dr. Gupta and colleagues did a meta-analysis of three studies that compared the effect of acetaminophen (3-4 g/day) versus placebo on systolic and diastolic ambulatory blood pressure in patients with heart disease or hypertension. Together, the studies included 172 adults (mean age, 60 years; 73% male).
They found that patients receiving acetaminophen had significantly higher systolic blood pressure, compared with those receiving placebo (standard mean difference [SMD] = 0.35; 95% confidence interval, 0.08-0.63; P = .01).
Subgroup analysis of the effect on hypertensive patients showed significant change in systolic blood pressure as well (SMD = 0.38; 95% CI, 0.05-0.71; P = .02).
“Interestingly, there was no significant difference in the effect on diastolic blood pressure,” Dr. Gupta commented.
Reached for comment, Timothy S. Anderson, MD, clinical investigator in the Division of General Medicine at Beth Israel Deaconess Medical Center and assistant professor of medicine at the Harvard Medical School, both in Boston, said this is “an interesting and not particularly well-known issue.”
“However, most of the trials look at very high doses of acetaminophen use (for example, six to eight of the 500 mg pills each day) so we don’t really know whether the more common patterns of using one to two acetaminophen pills every once in a while is problematic,” Dr. Anderson told this news organization.
“We also don’t have data showing a direct harm from these medications with regards to strokes or heart attacks or other downstream consequences of high blood pressure. Ideally we would need a head-to-head trial comparing ibuprofen-type medications to acetaminophen-type medications,” Dr. Anderson said.
The study had no specific funding. Dr. Gupta and Dr. Anderson reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
New research calls into question the assumption that acetaminophen is safer than NSAIDs for patients with known cardiovascular disease (CVD) or CVD risk factors.
The analysis found a significant correlation between the use of acetaminophen and elevated systolic blood pressure.
While acetaminophen may still be safer than NSAIDs from a bleeding risk standpoint, or in patients with known kidney disease, “the gap may not be as large as once thought,” Rahul Gupta, MD, cardiologist with Lehigh Valley Health Network, Allentown, Pa., said in an interview.
“Cautious use is recommended over the long term, especially in patients with pre-existing hypertension or cardiovascular risk factors,” Dr. Gupta said.
The study was presented at the Hypertension Scientific Sessions, San Diego, sponsored by the American Heart Association.
Acetaminophen is one of the most widely used over-the-counter medications, as it is considered a safer medication for long-term use since it lacks the anti-inflammatory effects of NSAIDs, Dr. Gupta explained.
NSAIDs have been known to raise blood pressure, but the effect of acetaminophen in this regard has not been well studied. Observational studies have shown contradictory results in terms of its effect on blood pressure, he noted.
To investigate further, Dr. Gupta and colleagues did a meta-analysis of three studies that compared the effect of acetaminophen (3-4 g/day) versus placebo on systolic and diastolic ambulatory blood pressure in patients with heart disease or hypertension. Together, the studies included 172 adults (mean age, 60 years; 73% male).
They found that patients receiving acetaminophen had significantly higher systolic blood pressure, compared with those receiving placebo (standard mean difference [SMD] = 0.35; 95% confidence interval, 0.08-0.63; P = .01).
Subgroup analysis of the effect on hypertensive patients showed significant change in systolic blood pressure as well (SMD = 0.38; 95% CI, 0.05-0.71; P = .02).
“Interestingly, there was no significant difference in the effect on diastolic blood pressure,” Dr. Gupta commented.
Reached for comment, Timothy S. Anderson, MD, clinical investigator in the Division of General Medicine at Beth Israel Deaconess Medical Center and assistant professor of medicine at the Harvard Medical School, both in Boston, said this is “an interesting and not particularly well-known issue.”
“However, most of the trials look at very high doses of acetaminophen use (for example, six to eight of the 500 mg pills each day) so we don’t really know whether the more common patterns of using one to two acetaminophen pills every once in a while is problematic,” Dr. Anderson told this news organization.
“We also don’t have data showing a direct harm from these medications with regards to strokes or heart attacks or other downstream consequences of high blood pressure. Ideally we would need a head-to-head trial comparing ibuprofen-type medications to acetaminophen-type medications,” Dr. Anderson said.
The study had no specific funding. Dr. Gupta and Dr. Anderson reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
New research calls into question the assumption that acetaminophen is safer than NSAIDs for patients with known cardiovascular disease (CVD) or CVD risk factors.
The analysis found a significant correlation between the use of acetaminophen and elevated systolic blood pressure.
While acetaminophen may still be safer than NSAIDs from a bleeding risk standpoint, or in patients with known kidney disease, “the gap may not be as large as once thought,” Rahul Gupta, MD, cardiologist with Lehigh Valley Health Network, Allentown, Pa., said in an interview.
“Cautious use is recommended over the long term, especially in patients with pre-existing hypertension or cardiovascular risk factors,” Dr. Gupta said.
The study was presented at the Hypertension Scientific Sessions, San Diego, sponsored by the American Heart Association.
Acetaminophen is one of the most widely used over-the-counter medications, as it is considered a safer medication for long-term use since it lacks the anti-inflammatory effects of NSAIDs, Dr. Gupta explained.
NSAIDs have been known to raise blood pressure, but the effect of acetaminophen in this regard has not been well studied. Observational studies have shown contradictory results in terms of its effect on blood pressure, he noted.
To investigate further, Dr. Gupta and colleagues did a meta-analysis of three studies that compared the effect of acetaminophen (3-4 g/day) versus placebo on systolic and diastolic ambulatory blood pressure in patients with heart disease or hypertension. Together, the studies included 172 adults (mean age, 60 years; 73% male).
They found that patients receiving acetaminophen had significantly higher systolic blood pressure, compared with those receiving placebo (standard mean difference [SMD] = 0.35; 95% confidence interval, 0.08-0.63; P = .01).
Subgroup analysis of the effect on hypertensive patients showed significant change in systolic blood pressure as well (SMD = 0.38; 95% CI, 0.05-0.71; P = .02).
“Interestingly, there was no significant difference in the effect on diastolic blood pressure,” Dr. Gupta commented.
Reached for comment, Timothy S. Anderson, MD, clinical investigator in the Division of General Medicine at Beth Israel Deaconess Medical Center and assistant professor of medicine at the Harvard Medical School, both in Boston, said this is “an interesting and not particularly well-known issue.”
“However, most of the trials look at very high doses of acetaminophen use (for example, six to eight of the 500 mg pills each day) so we don’t really know whether the more common patterns of using one to two acetaminophen pills every once in a while is problematic,” Dr. Anderson told this news organization.
“We also don’t have data showing a direct harm from these medications with regards to strokes or heart attacks or other downstream consequences of high blood pressure. Ideally we would need a head-to-head trial comparing ibuprofen-type medications to acetaminophen-type medications,” Dr. Anderson said.
The study had no specific funding. Dr. Gupta and Dr. Anderson reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM HYPERTENSION 2022
Detachment predicts worse posttraumatic outcomes
The results highlight the importance of screening for dissociation in patients who have experienced trauma, study investigator Lauren A.M. Lebois, PhD, director of the dissociative disorders and trauma research program at McLean Hospital in Belmont, Mass., told this news organization.
“Clinicians could identify individuals potentially at risk of a chronic, more severe psychiatric course before these people go down that road, and they have the opportunity to connect folks with a phased trauma treatment approach to speed their recovery,” said Dr. Lebois, who is also an assistant professor of psychiatry at Harvard Medical School, Boston.
The study was published in the American Journal of Psychiatry.
Underdiagnosed
Feelings of detachment or derealization are a type of dissociation. Patients with the syndrome report feeling foggy or as if they are in a dream. Dissociative diagnoses are not rare and, in fact, are more prevalent than schizophrenia.
Research supports a powerful relationship between dissociation and traumatic experiences. However, dissociation is among the most stigmatized of psychiatric conditions. Even among clinicians and researchers, beliefs about dissociation are often not based on the scientific literature, said Dr. Lebois.
“For instance, skepticism, misunderstanding, and lack of professional education about dissociation all contribute to striking rates of underdiagnosis and misdiagnoses,” she said.
Dr. Lebois and colleagues used data from the larger Advancing Understanding of Recovery After Trauma (AURORA) study and included 1,464 adults, mean age 35 years, appearing at 22 U.S. emergency departments. Patients experienced a traumatic event such as a motor vehicle crash or physical or sexual assault.
About 2 weeks after the trauma, participants reported symptoms of derealization as measured by a two-item version of the Brief Dissociative Experiences Scale.
Brain imaging data
A subset of 145 patients underwent functional MRI (fMRI), during which they completed an emotion reactivity task (viewing fearful-looking human faces) and a resting-state scan.
In addition to measuring history of childhood maltreatment, researchers assessed posttraumatic stress symptom severity at 2 weeks and again at 3 months using the posttraumatic stress disorder checklist. Also at 3 months, they measured depression and anxiety symptoms, pain, and functional impairment.
About 55% of self-report participants and 50% of MRI participants endorsed some level of persistent derealization at 2 weeks.
After controlling for potential confounders, including sex, age, childhood maltreatment, and current posttraumatic stress symptoms, researchers found persistent derealization was associated with increased ventromedial prefrontal cortex (vmPFC) activity while viewing fearful faces.
The vmPFC helps to regulate emotional and physical reactions. “This region puts the ‘brakes’ on your emotional and physical reactivity – helping you to calm down” after a threatening or stressful experience has passed, said Dr. Lebois.
Researchers also found an association between higher self-reported derealization and decreased resting-state connectivity between the vmPFC and the orbitofrontal cortex and right lobule VIIIa – a region of the cerebellum involved in sensorimotor function.
“This may contribute to perceptual and affective distortions experienced during derealization – for example, feelings that surroundings are fading away, unreal, or strange,” said Dr. Lebois.
More pain, depression, anxiety
Higher levels of self-reported derealization at 2 weeks post trauma predicted higher levels of PTSD, anxiety, and depression as well as more bodily pain and impairment in work, family, and social life at 3 months.
“When we accounted for baseline levels of posttraumatic stress symptoms and trauma history, higher levels of self-reported derealization still predicted higher posttraumatic stress disorder and depression symptoms at 3 months,” said Dr. Lebois.
Additional adjusted analyses showed increased vmPFC activity during the fearful face task predicted 3-month self-reported PTSD symptoms.
Dr. Lebois “highly recommends” clinicians screen for dissociative symptoms, including derealization, in patients with trauma. Self-report screening tools are freely available online.
She noted patients with significant dissociative symptoms often do better with a “phase-oriented” approach to trauma treatment.
“In phase one, they learn emotional regulation skills to help them take more control over when they dissociate. Then they can successfully move on to trauma processing in phase two, which can involve exposure to trauma details.”
Although the field is not yet ready to use brain scans to diagnose dissociative symptoms, the new results “take us one step closer to being able to use objective neuroimaging biomarkers of derealization to augment subjective self-report measures,” said Dr. Lebois.
A limitation of the study was it could not determine a causal relationship, as some derealization may have been present before the traumatic event. The findings may not generalize to other types of dissociation, and the derealization assessment was measured only through a self-report 2 weeks after the trauma.
Another limitation was exclusion of patients with self-inflicted injuries or who were involved in domestic violence. The researchers noted the prevalence of derealization might have been even higher if such individuals were included.
An important investigation
In an accompanying editorial, Lisa M. Shin, PhD, department of psychology, Tufts University, and department of psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, notes having both clinical and neuroimaging variables as well as a large sample size makes the study “an important investigation” into predictors of psychiatric symptoms post-trauma.
Investigating a specific subtype of dissociation – persistent derealization – adds to the “novelty” of the study, she said.
The new findings “are certainly exciting for their potential clinical relevance and contributions to neurocircuitry models of PTSD,” she writes.
Some may argue administering a short, self-report measure of derealization “is far more efficient, cost-effective, and inclusive than conducting a specialized and expensive fMRI scan that is unlikely to be available to everyone,” notes Dr. Shin.
However, she added, a potential benefit of such a scan is identification of specific brain regions as potential targets for intervention. “For example, the results of this and other studies suggest that the vmPFC is a reasonable target for transcranial magnetic stimulation or its variants.”
The new results need to be replicated in a large, independent sample, said Dr. Shin. She added it would be helpful to know if other types of dissociation, and activation in other subregions of the vmPFC, also predict psychiatric outcomes after a trauma.
The study was supported by National Institute of Mental Health grants, the U.S. Army Medical Research and Material Command, One Mind, and the Mayday Fund. Dr. Lebois has received grant support from NIMH, and her spouse receives payments from Vanderbilt University for technology licensed to Acadia Pharmaceuticals. Dr. Shin receives textbook-related royalties from Pearson.
A version of this article first appeared on Medscape.com.
The results highlight the importance of screening for dissociation in patients who have experienced trauma, study investigator Lauren A.M. Lebois, PhD, director of the dissociative disorders and trauma research program at McLean Hospital in Belmont, Mass., told this news organization.
“Clinicians could identify individuals potentially at risk of a chronic, more severe psychiatric course before these people go down that road, and they have the opportunity to connect folks with a phased trauma treatment approach to speed their recovery,” said Dr. Lebois, who is also an assistant professor of psychiatry at Harvard Medical School, Boston.
The study was published in the American Journal of Psychiatry.
Underdiagnosed
Feelings of detachment or derealization are a type of dissociation. Patients with the syndrome report feeling foggy or as if they are in a dream. Dissociative diagnoses are not rare and, in fact, are more prevalent than schizophrenia.
Research supports a powerful relationship between dissociation and traumatic experiences. However, dissociation is among the most stigmatized of psychiatric conditions. Even among clinicians and researchers, beliefs about dissociation are often not based on the scientific literature, said Dr. Lebois.
“For instance, skepticism, misunderstanding, and lack of professional education about dissociation all contribute to striking rates of underdiagnosis and misdiagnoses,” she said.
Dr. Lebois and colleagues used data from the larger Advancing Understanding of Recovery After Trauma (AURORA) study and included 1,464 adults, mean age 35 years, appearing at 22 U.S. emergency departments. Patients experienced a traumatic event such as a motor vehicle crash or physical or sexual assault.
About 2 weeks after the trauma, participants reported symptoms of derealization as measured by a two-item version of the Brief Dissociative Experiences Scale.
Brain imaging data
A subset of 145 patients underwent functional MRI (fMRI), during which they completed an emotion reactivity task (viewing fearful-looking human faces) and a resting-state scan.
In addition to measuring history of childhood maltreatment, researchers assessed posttraumatic stress symptom severity at 2 weeks and again at 3 months using the posttraumatic stress disorder checklist. Also at 3 months, they measured depression and anxiety symptoms, pain, and functional impairment.
About 55% of self-report participants and 50% of MRI participants endorsed some level of persistent derealization at 2 weeks.
After controlling for potential confounders, including sex, age, childhood maltreatment, and current posttraumatic stress symptoms, researchers found persistent derealization was associated with increased ventromedial prefrontal cortex (vmPFC) activity while viewing fearful faces.
The vmPFC helps to regulate emotional and physical reactions. “This region puts the ‘brakes’ on your emotional and physical reactivity – helping you to calm down” after a threatening or stressful experience has passed, said Dr. Lebois.
Researchers also found an association between higher self-reported derealization and decreased resting-state connectivity between the vmPFC and the orbitofrontal cortex and right lobule VIIIa – a region of the cerebellum involved in sensorimotor function.
“This may contribute to perceptual and affective distortions experienced during derealization – for example, feelings that surroundings are fading away, unreal, or strange,” said Dr. Lebois.
More pain, depression, anxiety
Higher levels of self-reported derealization at 2 weeks post trauma predicted higher levels of PTSD, anxiety, and depression as well as more bodily pain and impairment in work, family, and social life at 3 months.
“When we accounted for baseline levels of posttraumatic stress symptoms and trauma history, higher levels of self-reported derealization still predicted higher posttraumatic stress disorder and depression symptoms at 3 months,” said Dr. Lebois.
Additional adjusted analyses showed increased vmPFC activity during the fearful face task predicted 3-month self-reported PTSD symptoms.
Dr. Lebois “highly recommends” clinicians screen for dissociative symptoms, including derealization, in patients with trauma. Self-report screening tools are freely available online.
She noted patients with significant dissociative symptoms often do better with a “phase-oriented” approach to trauma treatment.
“In phase one, they learn emotional regulation skills to help them take more control over when they dissociate. Then they can successfully move on to trauma processing in phase two, which can involve exposure to trauma details.”
Although the field is not yet ready to use brain scans to diagnose dissociative symptoms, the new results “take us one step closer to being able to use objective neuroimaging biomarkers of derealization to augment subjective self-report measures,” said Dr. Lebois.
A limitation of the study was it could not determine a causal relationship, as some derealization may have been present before the traumatic event. The findings may not generalize to other types of dissociation, and the derealization assessment was measured only through a self-report 2 weeks after the trauma.
Another limitation was exclusion of patients with self-inflicted injuries or who were involved in domestic violence. The researchers noted the prevalence of derealization might have been even higher if such individuals were included.
An important investigation
In an accompanying editorial, Lisa M. Shin, PhD, department of psychology, Tufts University, and department of psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, notes having both clinical and neuroimaging variables as well as a large sample size makes the study “an important investigation” into predictors of psychiatric symptoms post-trauma.
Investigating a specific subtype of dissociation – persistent derealization – adds to the “novelty” of the study, she said.
The new findings “are certainly exciting for their potential clinical relevance and contributions to neurocircuitry models of PTSD,” she writes.
Some may argue administering a short, self-report measure of derealization “is far more efficient, cost-effective, and inclusive than conducting a specialized and expensive fMRI scan that is unlikely to be available to everyone,” notes Dr. Shin.
However, she added, a potential benefit of such a scan is identification of specific brain regions as potential targets for intervention. “For example, the results of this and other studies suggest that the vmPFC is a reasonable target for transcranial magnetic stimulation or its variants.”
The new results need to be replicated in a large, independent sample, said Dr. Shin. She added it would be helpful to know if other types of dissociation, and activation in other subregions of the vmPFC, also predict psychiatric outcomes after a trauma.
The study was supported by National Institute of Mental Health grants, the U.S. Army Medical Research and Material Command, One Mind, and the Mayday Fund. Dr. Lebois has received grant support from NIMH, and her spouse receives payments from Vanderbilt University for technology licensed to Acadia Pharmaceuticals. Dr. Shin receives textbook-related royalties from Pearson.
A version of this article first appeared on Medscape.com.
The results highlight the importance of screening for dissociation in patients who have experienced trauma, study investigator Lauren A.M. Lebois, PhD, director of the dissociative disorders and trauma research program at McLean Hospital in Belmont, Mass., told this news organization.
“Clinicians could identify individuals potentially at risk of a chronic, more severe psychiatric course before these people go down that road, and they have the opportunity to connect folks with a phased trauma treatment approach to speed their recovery,” said Dr. Lebois, who is also an assistant professor of psychiatry at Harvard Medical School, Boston.
The study was published in the American Journal of Psychiatry.
Underdiagnosed
Feelings of detachment or derealization are a type of dissociation. Patients with the syndrome report feeling foggy or as if they are in a dream. Dissociative diagnoses are not rare and, in fact, are more prevalent than schizophrenia.
Research supports a powerful relationship between dissociation and traumatic experiences. However, dissociation is among the most stigmatized of psychiatric conditions. Even among clinicians and researchers, beliefs about dissociation are often not based on the scientific literature, said Dr. Lebois.
“For instance, skepticism, misunderstanding, and lack of professional education about dissociation all contribute to striking rates of underdiagnosis and misdiagnoses,” she said.
Dr. Lebois and colleagues used data from the larger Advancing Understanding of Recovery After Trauma (AURORA) study and included 1,464 adults, mean age 35 years, appearing at 22 U.S. emergency departments. Patients experienced a traumatic event such as a motor vehicle crash or physical or sexual assault.
About 2 weeks after the trauma, participants reported symptoms of derealization as measured by a two-item version of the Brief Dissociative Experiences Scale.
Brain imaging data
A subset of 145 patients underwent functional MRI (fMRI), during which they completed an emotion reactivity task (viewing fearful-looking human faces) and a resting-state scan.
In addition to measuring history of childhood maltreatment, researchers assessed posttraumatic stress symptom severity at 2 weeks and again at 3 months using the posttraumatic stress disorder checklist. Also at 3 months, they measured depression and anxiety symptoms, pain, and functional impairment.
About 55% of self-report participants and 50% of MRI participants endorsed some level of persistent derealization at 2 weeks.
After controlling for potential confounders, including sex, age, childhood maltreatment, and current posttraumatic stress symptoms, researchers found persistent derealization was associated with increased ventromedial prefrontal cortex (vmPFC) activity while viewing fearful faces.
The vmPFC helps to regulate emotional and physical reactions. “This region puts the ‘brakes’ on your emotional and physical reactivity – helping you to calm down” after a threatening or stressful experience has passed, said Dr. Lebois.
Researchers also found an association between higher self-reported derealization and decreased resting-state connectivity between the vmPFC and the orbitofrontal cortex and right lobule VIIIa – a region of the cerebellum involved in sensorimotor function.
“This may contribute to perceptual and affective distortions experienced during derealization – for example, feelings that surroundings are fading away, unreal, or strange,” said Dr. Lebois.
More pain, depression, anxiety
Higher levels of self-reported derealization at 2 weeks post trauma predicted higher levels of PTSD, anxiety, and depression as well as more bodily pain and impairment in work, family, and social life at 3 months.
“When we accounted for baseline levels of posttraumatic stress symptoms and trauma history, higher levels of self-reported derealization still predicted higher posttraumatic stress disorder and depression symptoms at 3 months,” said Dr. Lebois.
Additional adjusted analyses showed increased vmPFC activity during the fearful face task predicted 3-month self-reported PTSD symptoms.
Dr. Lebois “highly recommends” clinicians screen for dissociative symptoms, including derealization, in patients with trauma. Self-report screening tools are freely available online.
She noted patients with significant dissociative symptoms often do better with a “phase-oriented” approach to trauma treatment.
“In phase one, they learn emotional regulation skills to help them take more control over when they dissociate. Then they can successfully move on to trauma processing in phase two, which can involve exposure to trauma details.”
Although the field is not yet ready to use brain scans to diagnose dissociative symptoms, the new results “take us one step closer to being able to use objective neuroimaging biomarkers of derealization to augment subjective self-report measures,” said Dr. Lebois.
A limitation of the study was it could not determine a causal relationship, as some derealization may have been present before the traumatic event. The findings may not generalize to other types of dissociation, and the derealization assessment was measured only through a self-report 2 weeks after the trauma.
Another limitation was exclusion of patients with self-inflicted injuries or who were involved in domestic violence. The researchers noted the prevalence of derealization might have been even higher if such individuals were included.
An important investigation
In an accompanying editorial, Lisa M. Shin, PhD, department of psychology, Tufts University, and department of psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, notes having both clinical and neuroimaging variables as well as a large sample size makes the study “an important investigation” into predictors of psychiatric symptoms post-trauma.
Investigating a specific subtype of dissociation – persistent derealization – adds to the “novelty” of the study, she said.
The new findings “are certainly exciting for their potential clinical relevance and contributions to neurocircuitry models of PTSD,” she writes.
Some may argue administering a short, self-report measure of derealization “is far more efficient, cost-effective, and inclusive than conducting a specialized and expensive fMRI scan that is unlikely to be available to everyone,” notes Dr. Shin.
However, she added, a potential benefit of such a scan is identification of specific brain regions as potential targets for intervention. “For example, the results of this and other studies suggest that the vmPFC is a reasonable target for transcranial magnetic stimulation or its variants.”
The new results need to be replicated in a large, independent sample, said Dr. Shin. She added it would be helpful to know if other types of dissociation, and activation in other subregions of the vmPFC, also predict psychiatric outcomes after a trauma.
The study was supported by National Institute of Mental Health grants, the U.S. Army Medical Research and Material Command, One Mind, and the Mayday Fund. Dr. Lebois has received grant support from NIMH, and her spouse receives payments from Vanderbilt University for technology licensed to Acadia Pharmaceuticals. Dr. Shin receives textbook-related royalties from Pearson.
A version of this article first appeared on Medscape.com.
FROM AMERICAN JOURNAL OF PSYCHIATRY
Depression as a terminal illness
Is there a place for palliative care?
In 2020, there were 5,224 suicide deaths registered in England and Wales.1 The Mental Health Foundation, a London-based charitable organization, reports that approximately 70% of such deaths are in patients with depression.2 The number of attempted suicides is much higher – the South West London and St. George’s Mental Health Trust estimates that at least 140,000 people attempt suicide in England and Wales every year.3
In suicidal depression, the psychological pain is often unbearable and feels overwhelmingly incompatible with life. One is no longer living but merely surviving, and eventually the exhaustion will lead to decompensation. This is marked by suicide. The goal is to end the suffering permanently and this is achieved through death.
Depression, like all other physical and mental illnesses, runs a course. This is highly variable between individuals and can be the case even between separate relapse episodes in the same patient. Like many diagnoses, depression is known to lead to death in a significant number of people. Many suicidally depressed patients feel that death will be an inevitable result of the illness.
Suicide is often viewed as a symptom of severe depression, but what if we considered death as part of the disease process itself? Consequently, would it be justifiable to consider depression in these patients as a form of terminal illness, since without treatment, the condition would lead to death? Accordingly, could there be a place for palliative care in a small minority of suicidally depressed patients? Taking such a perspective would mean that instead of placing the focus on the prevention of deaths and prolonging of lifespan, the focus would be on making the patients comfortable as the disease progresses, maintaining their dignity, and promoting autonomy.
Suicidal depression and rights
The rationale for this is that psychiatric patients do not have the capacity to make such decisions in the acute setting, because of the direct effects of the unwell mind on their decision-making processes and cognitive faculties. While this may be true in some cases, there is limited evidence that this applies to all suicidally depressed patients in all cases.
Another argument against allowing suicidally depressed patients to decline treatment is the notion that the episode of depression can be successfully treated, and the patients can return to their normal level of functioning. However, in individuals with a previous history of severe depression, it is possible that they will relapse again at some point. In the same way, a cancer can be treated, and patients could return to their baseline level of functioning, only for the cancer to then return later in life. In both cases, these relapses are emotionally and physically exhausting and painful to get through. The difference is that a cancer patient can decline further treatment and opt for no treatment or for palliative treatment, knowing that the disease will shorten life expectancy. For suicidal depression, this is not an option. Such patients may be sectioned, admitted, and treated against their will. Suicide, which could be considered a natural endpoint of the depressive illness, is unacceptable.
Is it fair to confiscate one’s right to decline treatment, solely because that person suffers from a mental illness, as opposed to a physical one? Numerous studies have demonstrated clear structural, neurological, and neurochemical changes in suicidal depression. This is evidence that such a condition encompasses a clear physical property. Other conditions, such as dementia and chronic pain, have previously been accepted for euthanasia in certain countries. Pain is a subjective experience of nociceptive and neurochemical signaling. In the same way, depression is a subjective experience involving aberrant neurochemical signaling. The difference is that physical pain can often be localized. However, patients with suicidal depression often experience very severe and tangible pain that can be difficult to articulate and for others to understand if they have never experienced it themselves.
Like distinct forms of physical pain, suicidal depression creates a different form of pain, but it is pain, nonetheless. Is it therefore fair for suicidally depressed patients to be given lesser rights than those suffering from physical illnesses in determining their fate?
Suicidal depression and capacity
A patient is assumed to have capacity unless proven otherwise. This is often the reverse when managing psychiatric patients. However, if patients are able to fulfill all criteria required for demonstrating capacity (understanding the information, retaining, weighing up, and communicating the decision), surely they have demonstrated capacity to make their decisions, whether that is to receive or to refuse treatment.
For physical illnesses, adults with capacity are permitted to make decisions that their treating teams may not agree with, but this disagreement alone is generally insufficient to override the decisions. These patients, unlike in suicidal depression, have the right to refuse lifesaving or life-prolonging treatment.
An argument for this is that in terminal physical illnesses, death is a passive process and neither the patient nor the physician are actively causing it. However, in many palliative settings, patients can be given medications and treatment for symptomatic relief, even if these may hasten their death. The principle that makes this permissible is that the primary aim is to improve the symptoms and ensure comfort. The unintended effect includes side effects and hastened death. Similarly, in suicidal depression, one could argue that the patient should be permitted medications that may hasten or lead to death, so long as the primary aim is to improve the symptoms of the unbearable mental pain and suffering.
Let us consider an alternative scenario. What if previously suicidal patients are currently in remission from depression and make advanced directives? In their current healthy state, they assert that if, in the future, they were to relapse, they would not want any form of treatment. Instead, they wish for the disease to run its course, which may end in death through suicide.
In this case, the circumstances in which the statement was made would be entirely valid – the patients at that moment have capacity, are not under coercion, are able to articulate logical thought processes, and their reasoning would not be affected by a concurrent psychiatric pathology. Furthermore, they can demonstrate that suicide is not an impulsive decision and have considered the consequences of suicide on themselves and others. If the patients can demonstrate all the above, what would the ethical grounds be for refusing this advanced directive?
Medical ethics
Below, I consider this debate in the context of four pillars of medical ethics.
Non-maleficence
To determine whether an action is in line with non-maleficence, one must ask whether the proposed treatment will improve or resolve one’s condition. In the case of severe suicidal depression, the treatment may help patients in the short term, but what happens if or when they relapse? The treatment will likely prolong life, but also inadvertently prolong suffering. What if the patients do not wish to go through this again? The treatment regime can be profoundly taxing for the patients, the loved ones, and sometimes even for the treating team. Are we doing more harm by forcing these patients to stay alive against their will?
Beneficence
Beneficence is the moral duty to promote the action that is in the patient’s best interest. But who should determine what the patient’s best interests are if the patient and the doctor disagree? Usually, this decision is made by the treating doctor, who considers the patient’s past and present wishes, beliefs and values, and capacity assessment. Supposing that the law was not a restriction, could one’s psychiatrist ever agree on psychiatric grounds alone that it is indeed in the patient’s best interests to die?
Doctors play a central role in the duty of care. But care does not always mean active treatment. Caring encompasses physical, psychological, and spiritual welfare and includes considering an individual patient’s dignity, personal circumstances, and wishes. In certain circumstances, keeping patients with capacity alive against their wishes could be more harmful than caring.
Autonomy
Autonomy gives the patients ultimate decision-making responsibility for their own lives. It allows patients with capacity to decline treatment that is recommended by their physicians and to make decisions regarding their own death. However, in suicidally depressed patients, this autonomy is confiscated. Severely unwell patients, at high risk of committing suicide, are not permitted the autonomy to make the decision regarding their treatment, suicide, and death.
Justice
A justice-orientated and utilitarian view questions whether spending resources on these patients wastes time, resources, and expertise, and whether resources should instead be spent on patients who do want treatment.
For example, the British National Health Service holds an outstanding debt of £13.4 billion.4 The financial cost of treating mental illness in 2020/2021 was £14.31 billion.5 The NHS estimates that wider costs to national economy, including welfare benefits, housing support, social workers, community support, lost productivity at work, etc., amounts to approximately £77 billion annually.6 Many severely depressed patients are so unwell that their ability to contribute to society, financially, socially, and otherwise, is minimal. If patients with capacity genuinely want to die and society would benefit from a reduction in the pressures on health and social care services, would it not be in both their best interests to allow them to die? This way, resources could be redirected to service users who would appreciate and benefit from them the most.
A consequentialist view focuses on whether the action will benefit the patient overall; the action itself is not so relevant. According to this view, keeping suicidally depressed patients alive against their wishes would be ethical if the patients lack capacity. Keeping them safe and treating them until they are better would overall be in the patients’ best interests. However, if the patients do have capacity and wish to die, forcing them to stay alive and undergo treatment against their wishes would merely prolong their suffering and thus could be considered unethical.
When enough is enough
In suicidal treatment-resistant depression, where the patient has tried multiple treatments over time and carefully considered alternatives, when is it time to stop trying? For physical illness, patients can refuse treatment provided they can demonstrate capacity. In depression, they can refuse treatment only if they can demonstrate that they are not at serious risk to themselves or others. Most societies consider suicide as a serious risk to self and therefore unacceptable. However, if we considered suicide as a natural endpoint of the disease process, should the patient have the right to refuse treatment and allow the disease to progress to death?
The treatment regime can be a lengthy process and the repeated failures to improve can be physically and mentally exhausting and further compound the hopelessness. Treatments often have side effects, which further erode the patient’s physical and mental wellbeing. Is there a time when giving up and withdrawing active treatment is in the patient’s best interests, especially if that is what the patient wants?
Terminal diseases are incurable and likely to hasten one’s death. Severe suicidal treatment-resistant depression conforms to both conditions – it is unresponsive to treatment and has a high likelihood of precipitating premature death through suicide. Most terminal illnesses can be managed with palliative treatment. In the context of severe suicidal depression, euthanasia and assisted suicide could be considered as means of palliative care.
Palliative care involves managing the patient’s symptomatology, dignity, and comfort. Euthanasia and assisted suicide help to address all of these. Like palliative care, euthanasia and assisted suicide aim to improve symptoms of depression by alleviating pain and suffering, even if they may hasten death.
Euthanasia and assisted suicide in severe depression
Euthanasia and assisted suicide are legal in seven countries. Two countries (Belgium and the Netherlands) permit euthanasia for psychiatric illnesses. Passive euthanasia is practiced in most countries, e.g., withholding artificial life support. In suicidal depression, it could be considered that this withholding of treatment may directly lead to death by suicide.
In active euthanasia and assisted suicide, the patient is given a chemical that will directly lead to death. Euthanasia and assisted suicide allow individuals to die with dignity in a controlled and organized manner. It ends the patients’ suffering and allows them to finally find peace. The difficulties that led them to seek euthanasia/assisted suicide indicate a loss of control of the pain and suffering in life, and euthanasia allows them to regain this control and autonomy through death. It allows these individuals to properly say goodbye to their loved ones, and a chance to share their thoughts and feelings.
In contrast, suicide is often covert, clandestine, and planned in secret, and it frequently requires individuals to be dishonest with their closest loved ones. The suicide often comes as a shock to the loved ones and profound grief, questions, anger, pain, sorrow, and guilt follow. These are due to questions that have been left unanswered, thoughts that were never shared, regret that they had not done more to help, and anguish knowing that their loved one died alone, in unbearable mental agony, unable to speak to anyone about this final hurdle.
Euthanasia and assisted suicide provide a path to overcome all these issues. They encourage open conversations between the patients, their loved ones, and the treating team. They promote transparency, mutual support, and help prepare the loved ones for the death. In this way, euthanasia and assisted suicide can benefit both the patient and the loved ones.
A significant proportion of severely suicidally depressed patients will eventually go on to commit or attempt suicide. Thus, giving them the autonomy to choose euthanasia or assisted suicide could be considered a kind, fair, and compassionate course of action, as it respects their wishes, and allows them to escape their suffering and to die with dignity.
Conclusion
Depression has historically never been considered a terminal illness, but there is undeniable evidence that a significant number of deaths every year are directly caused by depression. Should we therefore shift the focus from lifesaving and life-prolonging treatment to ensuring comfort and maintaining dignity by exploring palliative options for extremely suicidally depressed patients with capacity, who are adamant on ending their lives?
Euthanasia and assisted suicide for depression pose a profound paradox when viewed through a deontological lens. According to this, the correct course of action directly corresponds to what the most “moral” action would be. The moral stance would be to help those who are suffering. But what exactly constitutes “help”? Are euthanasia and assisted suicide helping or harming? Likewise, is keeping patients with capacity alive against their wishes helping or harming? Many believe that euthanasia, assisted suicide, and suicide itself are intrinsically and morally wrong. But this poses another clear impasse. Who should be the ones to decide whether an action is moral or not? Should it be the individual? The treating physician? Or society?
Dr. Chang graduated from Imperial College London with an MBBS (medicine and surgery) and a BSc (gastroenterology and hepatology) degree.
References
1. Office for National Statistics. Suicides in England and Wales – Office for National Statistics, 2021.
2. Faulkner, A. Suicide and Deliberate Self Harm: The Fundamental Facts. Mental Health Foundation; 1997.
3. NHS. Suicide Factsheet. Southwest London and St. George’s Mental Health NHS Trust [ebook], 2022.
4. The King’s Fund. Financial debts and loans in the NHS. 2020.
5. NHS England. Mental Health Five Year Forward View Dashboard. 2018.
6. National Mental Health, Policy into Practice. The costs of mental ill health.
Is there a place for palliative care?
Is there a place for palliative care?
In 2020, there were 5,224 suicide deaths registered in England and Wales.1 The Mental Health Foundation, a London-based charitable organization, reports that approximately 70% of such deaths are in patients with depression.2 The number of attempted suicides is much higher – the South West London and St. George’s Mental Health Trust estimates that at least 140,000 people attempt suicide in England and Wales every year.3
In suicidal depression, the psychological pain is often unbearable and feels overwhelmingly incompatible with life. One is no longer living but merely surviving, and eventually the exhaustion will lead to decompensation. This is marked by suicide. The goal is to end the suffering permanently and this is achieved through death.
Depression, like all other physical and mental illnesses, runs a course. This is highly variable between individuals and can be the case even between separate relapse episodes in the same patient. Like many diagnoses, depression is known to lead to death in a significant number of people. Many suicidally depressed patients feel that death will be an inevitable result of the illness.
Suicide is often viewed as a symptom of severe depression, but what if we considered death as part of the disease process itself? Consequently, would it be justifiable to consider depression in these patients as a form of terminal illness, since without treatment, the condition would lead to death? Accordingly, could there be a place for palliative care in a small minority of suicidally depressed patients? Taking such a perspective would mean that instead of placing the focus on the prevention of deaths and prolonging of lifespan, the focus would be on making the patients comfortable as the disease progresses, maintaining their dignity, and promoting autonomy.
Suicidal depression and rights
The rationale for this is that psychiatric patients do not have the capacity to make such decisions in the acute setting, because of the direct effects of the unwell mind on their decision-making processes and cognitive faculties. While this may be true in some cases, there is limited evidence that this applies to all suicidally depressed patients in all cases.
Another argument against allowing suicidally depressed patients to decline treatment is the notion that the episode of depression can be successfully treated, and the patients can return to their normal level of functioning. However, in individuals with a previous history of severe depression, it is possible that they will relapse again at some point. In the same way, a cancer can be treated, and patients could return to their baseline level of functioning, only for the cancer to then return later in life. In both cases, these relapses are emotionally and physically exhausting and painful to get through. The difference is that a cancer patient can decline further treatment and opt for no treatment or for palliative treatment, knowing that the disease will shorten life expectancy. For suicidal depression, this is not an option. Such patients may be sectioned, admitted, and treated against their will. Suicide, which could be considered a natural endpoint of the depressive illness, is unacceptable.
Is it fair to confiscate one’s right to decline treatment, solely because that person suffers from a mental illness, as opposed to a physical one? Numerous studies have demonstrated clear structural, neurological, and neurochemical changes in suicidal depression. This is evidence that such a condition encompasses a clear physical property. Other conditions, such as dementia and chronic pain, have previously been accepted for euthanasia in certain countries. Pain is a subjective experience of nociceptive and neurochemical signaling. In the same way, depression is a subjective experience involving aberrant neurochemical signaling. The difference is that physical pain can often be localized. However, patients with suicidal depression often experience very severe and tangible pain that can be difficult to articulate and for others to understand if they have never experienced it themselves.
Like distinct forms of physical pain, suicidal depression creates a different form of pain, but it is pain, nonetheless. Is it therefore fair for suicidally depressed patients to be given lesser rights than those suffering from physical illnesses in determining their fate?
Suicidal depression and capacity
A patient is assumed to have capacity unless proven otherwise. This is often the reverse when managing psychiatric patients. However, if patients are able to fulfill all criteria required for demonstrating capacity (understanding the information, retaining, weighing up, and communicating the decision), surely they have demonstrated capacity to make their decisions, whether that is to receive or to refuse treatment.
For physical illnesses, adults with capacity are permitted to make decisions that their treating teams may not agree with, but this disagreement alone is generally insufficient to override the decisions. These patients, unlike in suicidal depression, have the right to refuse lifesaving or life-prolonging treatment.
An argument for this is that in terminal physical illnesses, death is a passive process and neither the patient nor the physician are actively causing it. However, in many palliative settings, patients can be given medications and treatment for symptomatic relief, even if these may hasten their death. The principle that makes this permissible is that the primary aim is to improve the symptoms and ensure comfort. The unintended effect includes side effects and hastened death. Similarly, in suicidal depression, one could argue that the patient should be permitted medications that may hasten or lead to death, so long as the primary aim is to improve the symptoms of the unbearable mental pain and suffering.
Let us consider an alternative scenario. What if previously suicidal patients are currently in remission from depression and make advanced directives? In their current healthy state, they assert that if, in the future, they were to relapse, they would not want any form of treatment. Instead, they wish for the disease to run its course, which may end in death through suicide.
In this case, the circumstances in which the statement was made would be entirely valid – the patients at that moment have capacity, are not under coercion, are able to articulate logical thought processes, and their reasoning would not be affected by a concurrent psychiatric pathology. Furthermore, they can demonstrate that suicide is not an impulsive decision and have considered the consequences of suicide on themselves and others. If the patients can demonstrate all the above, what would the ethical grounds be for refusing this advanced directive?
Medical ethics
Below, I consider this debate in the context of four pillars of medical ethics.
Non-maleficence
To determine whether an action is in line with non-maleficence, one must ask whether the proposed treatment will improve or resolve one’s condition. In the case of severe suicidal depression, the treatment may help patients in the short term, but what happens if or when they relapse? The treatment will likely prolong life, but also inadvertently prolong suffering. What if the patients do not wish to go through this again? The treatment regime can be profoundly taxing for the patients, the loved ones, and sometimes even for the treating team. Are we doing more harm by forcing these patients to stay alive against their will?
Beneficence
Beneficence is the moral duty to promote the action that is in the patient’s best interest. But who should determine what the patient’s best interests are if the patient and the doctor disagree? Usually, this decision is made by the treating doctor, who considers the patient’s past and present wishes, beliefs and values, and capacity assessment. Supposing that the law was not a restriction, could one’s psychiatrist ever agree on psychiatric grounds alone that it is indeed in the patient’s best interests to die?
Doctors play a central role in the duty of care. But care does not always mean active treatment. Caring encompasses physical, psychological, and spiritual welfare and includes considering an individual patient’s dignity, personal circumstances, and wishes. In certain circumstances, keeping patients with capacity alive against their wishes could be more harmful than caring.
Autonomy
Autonomy gives the patients ultimate decision-making responsibility for their own lives. It allows patients with capacity to decline treatment that is recommended by their physicians and to make decisions regarding their own death. However, in suicidally depressed patients, this autonomy is confiscated. Severely unwell patients, at high risk of committing suicide, are not permitted the autonomy to make the decision regarding their treatment, suicide, and death.
Justice
A justice-orientated and utilitarian view questions whether spending resources on these patients wastes time, resources, and expertise, and whether resources should instead be spent on patients who do want treatment.
For example, the British National Health Service holds an outstanding debt of £13.4 billion.4 The financial cost of treating mental illness in 2020/2021 was £14.31 billion.5 The NHS estimates that wider costs to national economy, including welfare benefits, housing support, social workers, community support, lost productivity at work, etc., amounts to approximately £77 billion annually.6 Many severely depressed patients are so unwell that their ability to contribute to society, financially, socially, and otherwise, is minimal. If patients with capacity genuinely want to die and society would benefit from a reduction in the pressures on health and social care services, would it not be in both their best interests to allow them to die? This way, resources could be redirected to service users who would appreciate and benefit from them the most.
A consequentialist view focuses on whether the action will benefit the patient overall; the action itself is not so relevant. According to this view, keeping suicidally depressed patients alive against their wishes would be ethical if the patients lack capacity. Keeping them safe and treating them until they are better would overall be in the patients’ best interests. However, if the patients do have capacity and wish to die, forcing them to stay alive and undergo treatment against their wishes would merely prolong their suffering and thus could be considered unethical.
When enough is enough
In suicidal treatment-resistant depression, where the patient has tried multiple treatments over time and carefully considered alternatives, when is it time to stop trying? For physical illness, patients can refuse treatment provided they can demonstrate capacity. In depression, they can refuse treatment only if they can demonstrate that they are not at serious risk to themselves or others. Most societies consider suicide as a serious risk to self and therefore unacceptable. However, if we considered suicide as a natural endpoint of the disease process, should the patient have the right to refuse treatment and allow the disease to progress to death?
The treatment regime can be a lengthy process and the repeated failures to improve can be physically and mentally exhausting and further compound the hopelessness. Treatments often have side effects, which further erode the patient’s physical and mental wellbeing. Is there a time when giving up and withdrawing active treatment is in the patient’s best interests, especially if that is what the patient wants?
Terminal diseases are incurable and likely to hasten one’s death. Severe suicidal treatment-resistant depression conforms to both conditions – it is unresponsive to treatment and has a high likelihood of precipitating premature death through suicide. Most terminal illnesses can be managed with palliative treatment. In the context of severe suicidal depression, euthanasia and assisted suicide could be considered as means of palliative care.
Palliative care involves managing the patient’s symptomatology, dignity, and comfort. Euthanasia and assisted suicide help to address all of these. Like palliative care, euthanasia and assisted suicide aim to improve symptoms of depression by alleviating pain and suffering, even if they may hasten death.
Euthanasia and assisted suicide in severe depression
Euthanasia and assisted suicide are legal in seven countries. Two countries (Belgium and the Netherlands) permit euthanasia for psychiatric illnesses. Passive euthanasia is practiced in most countries, e.g., withholding artificial life support. In suicidal depression, it could be considered that this withholding of treatment may directly lead to death by suicide.
In active euthanasia and assisted suicide, the patient is given a chemical that will directly lead to death. Euthanasia and assisted suicide allow individuals to die with dignity in a controlled and organized manner. It ends the patients’ suffering and allows them to finally find peace. The difficulties that led them to seek euthanasia/assisted suicide indicate a loss of control of the pain and suffering in life, and euthanasia allows them to regain this control and autonomy through death. It allows these individuals to properly say goodbye to their loved ones, and a chance to share their thoughts and feelings.
In contrast, suicide is often covert, clandestine, and planned in secret, and it frequently requires individuals to be dishonest with their closest loved ones. The suicide often comes as a shock to the loved ones and profound grief, questions, anger, pain, sorrow, and guilt follow. These are due to questions that have been left unanswered, thoughts that were never shared, regret that they had not done more to help, and anguish knowing that their loved one died alone, in unbearable mental agony, unable to speak to anyone about this final hurdle.
Euthanasia and assisted suicide provide a path to overcome all these issues. They encourage open conversations between the patients, their loved ones, and the treating team. They promote transparency, mutual support, and help prepare the loved ones for the death. In this way, euthanasia and assisted suicide can benefit both the patient and the loved ones.
A significant proportion of severely suicidally depressed patients will eventually go on to commit or attempt suicide. Thus, giving them the autonomy to choose euthanasia or assisted suicide could be considered a kind, fair, and compassionate course of action, as it respects their wishes, and allows them to escape their suffering and to die with dignity.
Conclusion
Depression has historically never been considered a terminal illness, but there is undeniable evidence that a significant number of deaths every year are directly caused by depression. Should we therefore shift the focus from lifesaving and life-prolonging treatment to ensuring comfort and maintaining dignity by exploring palliative options for extremely suicidally depressed patients with capacity, who are adamant on ending their lives?
Euthanasia and assisted suicide for depression pose a profound paradox when viewed through a deontological lens. According to this, the correct course of action directly corresponds to what the most “moral” action would be. The moral stance would be to help those who are suffering. But what exactly constitutes “help”? Are euthanasia and assisted suicide helping or harming? Likewise, is keeping patients with capacity alive against their wishes helping or harming? Many believe that euthanasia, assisted suicide, and suicide itself are intrinsically and morally wrong. But this poses another clear impasse. Who should be the ones to decide whether an action is moral or not? Should it be the individual? The treating physician? Or society?
Dr. Chang graduated from Imperial College London with an MBBS (medicine and surgery) and a BSc (gastroenterology and hepatology) degree.
References
1. Office for National Statistics. Suicides in England and Wales – Office for National Statistics, 2021.
2. Faulkner, A. Suicide and Deliberate Self Harm: The Fundamental Facts. Mental Health Foundation; 1997.
3. NHS. Suicide Factsheet. Southwest London and St. George’s Mental Health NHS Trust [ebook], 2022.
4. The King’s Fund. Financial debts and loans in the NHS. 2020.
5. NHS England. Mental Health Five Year Forward View Dashboard. 2018.
6. National Mental Health, Policy into Practice. The costs of mental ill health.
In 2020, there were 5,224 suicide deaths registered in England and Wales.1 The Mental Health Foundation, a London-based charitable organization, reports that approximately 70% of such deaths are in patients with depression.2 The number of attempted suicides is much higher – the South West London and St. George’s Mental Health Trust estimates that at least 140,000 people attempt suicide in England and Wales every year.3
In suicidal depression, the psychological pain is often unbearable and feels overwhelmingly incompatible with life. One is no longer living but merely surviving, and eventually the exhaustion will lead to decompensation. This is marked by suicide. The goal is to end the suffering permanently and this is achieved through death.
Depression, like all other physical and mental illnesses, runs a course. This is highly variable between individuals and can be the case even between separate relapse episodes in the same patient. Like many diagnoses, depression is known to lead to death in a significant number of people. Many suicidally depressed patients feel that death will be an inevitable result of the illness.
Suicide is often viewed as a symptom of severe depression, but what if we considered death as part of the disease process itself? Consequently, would it be justifiable to consider depression in these patients as a form of terminal illness, since without treatment, the condition would lead to death? Accordingly, could there be a place for palliative care in a small minority of suicidally depressed patients? Taking such a perspective would mean that instead of placing the focus on the prevention of deaths and prolonging of lifespan, the focus would be on making the patients comfortable as the disease progresses, maintaining their dignity, and promoting autonomy.
Suicidal depression and rights
The rationale for this is that psychiatric patients do not have the capacity to make such decisions in the acute setting, because of the direct effects of the unwell mind on their decision-making processes and cognitive faculties. While this may be true in some cases, there is limited evidence that this applies to all suicidally depressed patients in all cases.
Another argument against allowing suicidally depressed patients to decline treatment is the notion that the episode of depression can be successfully treated, and the patients can return to their normal level of functioning. However, in individuals with a previous history of severe depression, it is possible that they will relapse again at some point. In the same way, a cancer can be treated, and patients could return to their baseline level of functioning, only for the cancer to then return later in life. In both cases, these relapses are emotionally and physically exhausting and painful to get through. The difference is that a cancer patient can decline further treatment and opt for no treatment or for palliative treatment, knowing that the disease will shorten life expectancy. For suicidal depression, this is not an option. Such patients may be sectioned, admitted, and treated against their will. Suicide, which could be considered a natural endpoint of the depressive illness, is unacceptable.
Is it fair to confiscate one’s right to decline treatment, solely because that person suffers from a mental illness, as opposed to a physical one? Numerous studies have demonstrated clear structural, neurological, and neurochemical changes in suicidal depression. This is evidence that such a condition encompasses a clear physical property. Other conditions, such as dementia and chronic pain, have previously been accepted for euthanasia in certain countries. Pain is a subjective experience of nociceptive and neurochemical signaling. In the same way, depression is a subjective experience involving aberrant neurochemical signaling. The difference is that physical pain can often be localized. However, patients with suicidal depression often experience very severe and tangible pain that can be difficult to articulate and for others to understand if they have never experienced it themselves.
Like distinct forms of physical pain, suicidal depression creates a different form of pain, but it is pain, nonetheless. Is it therefore fair for suicidally depressed patients to be given lesser rights than those suffering from physical illnesses in determining their fate?
Suicidal depression and capacity
A patient is assumed to have capacity unless proven otherwise. This is often the reverse when managing psychiatric patients. However, if patients are able to fulfill all criteria required for demonstrating capacity (understanding the information, retaining, weighing up, and communicating the decision), surely they have demonstrated capacity to make their decisions, whether that is to receive or to refuse treatment.
For physical illnesses, adults with capacity are permitted to make decisions that their treating teams may not agree with, but this disagreement alone is generally insufficient to override the decisions. These patients, unlike in suicidal depression, have the right to refuse lifesaving or life-prolonging treatment.
An argument for this is that in terminal physical illnesses, death is a passive process and neither the patient nor the physician are actively causing it. However, in many palliative settings, patients can be given medications and treatment for symptomatic relief, even if these may hasten their death. The principle that makes this permissible is that the primary aim is to improve the symptoms and ensure comfort. The unintended effect includes side effects and hastened death. Similarly, in suicidal depression, one could argue that the patient should be permitted medications that may hasten or lead to death, so long as the primary aim is to improve the symptoms of the unbearable mental pain and suffering.
Let us consider an alternative scenario. What if previously suicidal patients are currently in remission from depression and make advanced directives? In their current healthy state, they assert that if, in the future, they were to relapse, they would not want any form of treatment. Instead, they wish for the disease to run its course, which may end in death through suicide.
In this case, the circumstances in which the statement was made would be entirely valid – the patients at that moment have capacity, are not under coercion, are able to articulate logical thought processes, and their reasoning would not be affected by a concurrent psychiatric pathology. Furthermore, they can demonstrate that suicide is not an impulsive decision and have considered the consequences of suicide on themselves and others. If the patients can demonstrate all the above, what would the ethical grounds be for refusing this advanced directive?
Medical ethics
Below, I consider this debate in the context of four pillars of medical ethics.
Non-maleficence
To determine whether an action is in line with non-maleficence, one must ask whether the proposed treatment will improve or resolve one’s condition. In the case of severe suicidal depression, the treatment may help patients in the short term, but what happens if or when they relapse? The treatment will likely prolong life, but also inadvertently prolong suffering. What if the patients do not wish to go through this again? The treatment regime can be profoundly taxing for the patients, the loved ones, and sometimes even for the treating team. Are we doing more harm by forcing these patients to stay alive against their will?
Beneficence
Beneficence is the moral duty to promote the action that is in the patient’s best interest. But who should determine what the patient’s best interests are if the patient and the doctor disagree? Usually, this decision is made by the treating doctor, who considers the patient’s past and present wishes, beliefs and values, and capacity assessment. Supposing that the law was not a restriction, could one’s psychiatrist ever agree on psychiatric grounds alone that it is indeed in the patient’s best interests to die?
Doctors play a central role in the duty of care. But care does not always mean active treatment. Caring encompasses physical, psychological, and spiritual welfare and includes considering an individual patient’s dignity, personal circumstances, and wishes. In certain circumstances, keeping patients with capacity alive against their wishes could be more harmful than caring.
Autonomy
Autonomy gives the patients ultimate decision-making responsibility for their own lives. It allows patients with capacity to decline treatment that is recommended by their physicians and to make decisions regarding their own death. However, in suicidally depressed patients, this autonomy is confiscated. Severely unwell patients, at high risk of committing suicide, are not permitted the autonomy to make the decision regarding their treatment, suicide, and death.
Justice
A justice-orientated and utilitarian view questions whether spending resources on these patients wastes time, resources, and expertise, and whether resources should instead be spent on patients who do want treatment.
For example, the British National Health Service holds an outstanding debt of £13.4 billion.4 The financial cost of treating mental illness in 2020/2021 was £14.31 billion.5 The NHS estimates that wider costs to national economy, including welfare benefits, housing support, social workers, community support, lost productivity at work, etc., amounts to approximately £77 billion annually.6 Many severely depressed patients are so unwell that their ability to contribute to society, financially, socially, and otherwise, is minimal. If patients with capacity genuinely want to die and society would benefit from a reduction in the pressures on health and social care services, would it not be in both their best interests to allow them to die? This way, resources could be redirected to service users who would appreciate and benefit from them the most.
A consequentialist view focuses on whether the action will benefit the patient overall; the action itself is not so relevant. According to this view, keeping suicidally depressed patients alive against their wishes would be ethical if the patients lack capacity. Keeping them safe and treating them until they are better would overall be in the patients’ best interests. However, if the patients do have capacity and wish to die, forcing them to stay alive and undergo treatment against their wishes would merely prolong their suffering and thus could be considered unethical.
When enough is enough
In suicidal treatment-resistant depression, where the patient has tried multiple treatments over time and carefully considered alternatives, when is it time to stop trying? For physical illness, patients can refuse treatment provided they can demonstrate capacity. In depression, they can refuse treatment only if they can demonstrate that they are not at serious risk to themselves or others. Most societies consider suicide as a serious risk to self and therefore unacceptable. However, if we considered suicide as a natural endpoint of the disease process, should the patient have the right to refuse treatment and allow the disease to progress to death?
The treatment regime can be a lengthy process and the repeated failures to improve can be physically and mentally exhausting and further compound the hopelessness. Treatments often have side effects, which further erode the patient’s physical and mental wellbeing. Is there a time when giving up and withdrawing active treatment is in the patient’s best interests, especially if that is what the patient wants?
Terminal diseases are incurable and likely to hasten one’s death. Severe suicidal treatment-resistant depression conforms to both conditions – it is unresponsive to treatment and has a high likelihood of precipitating premature death through suicide. Most terminal illnesses can be managed with palliative treatment. In the context of severe suicidal depression, euthanasia and assisted suicide could be considered as means of palliative care.
Palliative care involves managing the patient’s symptomatology, dignity, and comfort. Euthanasia and assisted suicide help to address all of these. Like palliative care, euthanasia and assisted suicide aim to improve symptoms of depression by alleviating pain and suffering, even if they may hasten death.
Euthanasia and assisted suicide in severe depression
Euthanasia and assisted suicide are legal in seven countries. Two countries (Belgium and the Netherlands) permit euthanasia for psychiatric illnesses. Passive euthanasia is practiced in most countries, e.g., withholding artificial life support. In suicidal depression, it could be considered that this withholding of treatment may directly lead to death by suicide.
In active euthanasia and assisted suicide, the patient is given a chemical that will directly lead to death. Euthanasia and assisted suicide allow individuals to die with dignity in a controlled and organized manner. It ends the patients’ suffering and allows them to finally find peace. The difficulties that led them to seek euthanasia/assisted suicide indicate a loss of control of the pain and suffering in life, and euthanasia allows them to regain this control and autonomy through death. It allows these individuals to properly say goodbye to their loved ones, and a chance to share their thoughts and feelings.
In contrast, suicide is often covert, clandestine, and planned in secret, and it frequently requires individuals to be dishonest with their closest loved ones. The suicide often comes as a shock to the loved ones and profound grief, questions, anger, pain, sorrow, and guilt follow. These are due to questions that have been left unanswered, thoughts that were never shared, regret that they had not done more to help, and anguish knowing that their loved one died alone, in unbearable mental agony, unable to speak to anyone about this final hurdle.
Euthanasia and assisted suicide provide a path to overcome all these issues. They encourage open conversations between the patients, their loved ones, and the treating team. They promote transparency, mutual support, and help prepare the loved ones for the death. In this way, euthanasia and assisted suicide can benefit both the patient and the loved ones.
A significant proportion of severely suicidally depressed patients will eventually go on to commit or attempt suicide. Thus, giving them the autonomy to choose euthanasia or assisted suicide could be considered a kind, fair, and compassionate course of action, as it respects their wishes, and allows them to escape their suffering and to die with dignity.
Conclusion
Depression has historically never been considered a terminal illness, but there is undeniable evidence that a significant number of deaths every year are directly caused by depression. Should we therefore shift the focus from lifesaving and life-prolonging treatment to ensuring comfort and maintaining dignity by exploring palliative options for extremely suicidally depressed patients with capacity, who are adamant on ending their lives?
Euthanasia and assisted suicide for depression pose a profound paradox when viewed through a deontological lens. According to this, the correct course of action directly corresponds to what the most “moral” action would be. The moral stance would be to help those who are suffering. But what exactly constitutes “help”? Are euthanasia and assisted suicide helping or harming? Likewise, is keeping patients with capacity alive against their wishes helping or harming? Many believe that euthanasia, assisted suicide, and suicide itself are intrinsically and morally wrong. But this poses another clear impasse. Who should be the ones to decide whether an action is moral or not? Should it be the individual? The treating physician? Or society?
Dr. Chang graduated from Imperial College London with an MBBS (medicine and surgery) and a BSc (gastroenterology and hepatology) degree.
References
1. Office for National Statistics. Suicides in England and Wales – Office for National Statistics, 2021.
2. Faulkner, A. Suicide and Deliberate Self Harm: The Fundamental Facts. Mental Health Foundation; 1997.
3. NHS. Suicide Factsheet. Southwest London and St. George’s Mental Health NHS Trust [ebook], 2022.
4. The King’s Fund. Financial debts and loans in the NHS. 2020.
5. NHS England. Mental Health Five Year Forward View Dashboard. 2018.
6. National Mental Health, Policy into Practice. The costs of mental ill health.
New ESC guidelines for cutting CV risk in noncardiac surgery
The European Society of Cardiology guidelines on cardiovascular assessment and management of patients undergoing noncardiac surgery have seen extensive revision since the 2014 version.
They still have the same aim – to prevent surgery-related bleeding complications, perioperative myocardial infarction/injury (PMI), stent thrombosis, acute heart failure, arrhythmias, pulmonary embolism, ischemic stroke, and cardiovascular (CV) death.
Cochairpersons Sigrun Halvorsen, MD, PhD, and Julinda Mehilli, MD, presented highlights from the guidelines at the annual congress of the European Society of Cardiology and the document was simultaneously published online in the European Heart Journal.
The document classifies noncardiac surgery into three levels of 30-day risk of CV death, MI, or stroke. Low (< 1%) risk includes eye or thyroid surgery; intermediate (1%-5%) risk includes knee or hip replacement or renal transplant; and high (> 5%) risk includes aortic aneurysm, lung transplant, or pancreatic or bladder cancer surgery (see more examples below).
It classifies patients as low risk if they are younger than 65 without CV disease or CV risk factors (smoking, hypertension, diabetes, dyslipidemia, family history); intermediate risk if they are 65 or older or have CV risk factors; and high risk if they have CVD.
In an interview, Dr. Halvorsen, professor in cardiology, University of Oslo, zeroed in on three important revisions:
First, recommendations for preoperative ECG and biomarkers are more specific, he noted.
The guidelines advise that before intermediate- or high-risk noncardiac surgery, in patients who have known CVD, CV risk factors (including age 65 or older), or symptoms suggestive of CVD:
- It is recommended to obtain a preoperative 12-lead ECG (class I).
- It is recommended to measure high-sensitivity cardiac troponin T (hs-cTn T) or high-sensitivity cardiac troponin I (hs-cTn I). It is also recommended to measure these biomarkers at 24 hours and 48 hours post surgery (class I).
- It should be considered to measure B-type natriuretic peptide or N-terminal of the prohormone BNP (NT-proBNP).
However, for low-risk patients undergoing low- and intermediate-risk noncardiac surgery, it is not recommended to routinely obtain preoperative ECG, hs-cTn T/I, or BNP/NT-proBNP concentrations (class III).
Troponins have a stronger class I recommendation, compared with the IIA recommendation for BNP, because they are useful for preoperative risk stratification and for diagnosis of PMI, Dr. Halvorsen explained. “Patients receive painkillers after surgery and may have no pain,” she noted, but they may have PMI, which has a bad prognosis.
Second, the guidelines recommend that “all patients should stop smoking 4 weeks before noncardiac surgery [class I],” she noted. Clinicians should also “measure hemoglobin, and if the patient is anemic, treat the anemia.”
Third, the sections on antithrombotic treatment have been significantly revised. “Bridging – stopping an oral antithrombotic drug and switching to a subcutaneous or IV drug – has been common,” Dr. Halvorsen said, “but recently we have new evidence that in most cases that increases the risk of bleeding.”
“We are [now] much more restrictive with respect to bridging” with unfractionated heparin or low-molecular-weight heparin, she said. “We recommend against bridging in patients with low to moderate thrombotic risk,” and bridging should only be considered in patients with mechanical prosthetic heart valves or with very high thrombotic risk.
More preoperative recommendations
In the guideline overview session at the congress, Dr. Halverson highlighted some of the new recommendations for preoperative risk assessment.
If time allows, it is recommended to optimize guideline-recommended treatment of CVD and control of CV risk factors including blood pressure, dyslipidemia, and diabetes, before noncardiac surgery (class I).
Patients commonly have “murmurs, chest pain, dyspnea, and edema that may suggest severe CVD, but may also be caused by noncardiac disease,” she noted. The guidelines state that “for patients with a newly detected murmur and symptoms or signs of CVD, transthoracic echocardiography is recommended before noncardiac surgery (class I).
“Many studies have been performed to try to find out if initiation of specific drugs before surgery could reduce the risk of complications,” Dr. Halvorsen noted. However, few have shown any benefit and “the question of presurgery initiation of beta-blockers has been greatly debated,” she said. “We have again reviewed the literature and concluded ‘Routine initiation of beta-blockers perioperatively is not recommended (class IIIA).’ “
“We adhere to the guidelines on acute and chronic coronary syndrome recommending 6-12 months of dual antiplatelet treatment as a standard before elective surgery,” she said. “However, in case of time-sensitive surgery, the duration of that treatment can be shortened down to a minimum of 1 month after elective PCI and a minimum of 3 months after PCI and ACS.”
Patients with specific types of CVD
Dr. Mehilli, a professor at Landshut-Achdorf (Germany) Hospital, highlighted some new guideline recommendations for patients who have specific types of cardiovascular disease.
Coronary artery disease (CAD). “For chronic coronary syndrome, a cardiac workup is recommended only for patients undergoing intermediate risk or high-risk noncardiac surgery.”
“Stress imaging should be considered before any high risk, noncardiac surgery in asymptomatic patients with poor functional capacity and prior PCI or coronary artery bypass graft (new recommendation, class IIa).”
Mitral valve regurgitation. For patients undergoing scheduled noncardiac surgery, who remain symptomatic despite guideline-directed medical treatment for mitral valve regurgitation (including resynchronization and myocardial revascularization), consider a valve intervention – either transcatheter or surgical – before noncardiac surgery in eligible patients with acceptable procedural risk (new recommendation).
Cardiac implantable electronic devices (CIED). For high-risk patients with CIEDs undergoing noncardiac surgery with high probability of electromagnetic interference, a CIED checkup and necessary reprogramming immediately before the procedure should be considered (new recommendation).
Arrhythmias. “I want only to stress,” Dr. Mehilli said, “in patients with atrial fibrillation with acute or worsening hemodynamic instability undergoing noncardiac surgery, an emergency electrical cardioversion is recommended (class I).”
Peripheral artery disease (PAD) and abdominal aortic aneurysm. For these patients “we do not recommend a routine referral for a cardiac workup. But we recommend it for patients with poor functional capacity or with significant risk factors or symptoms (new recommendations).”
Chronic arterial hypertension. “We have modified the recommendation, recommending avoidance of large perioperative fluctuations in blood pressure, and we do not recommend deferring noncardiac surgery in patients with stage 1 or 2 hypertension,” she said.
Postoperative cardiovascular complications
The most frequent postoperative cardiovascular complication is PMI, Dr. Mehilli noted.
“In the BASEL-PMI registry, the incidence of this complication around intermediate or high-risk noncardiac surgery was up to 15% among patients older than 65 years or with a history of CAD or PAD, which makes this kind of complication really important to prevent, to assess, and to know how to treat.”
“It is recommended to have a high awareness for perioperative cardiovascular complications, combined with surveillance for PMI in patients undergoing intermediate- or high-risk noncardiac surgery” based on serial measurements of high-sensitivity cardiac troponin.
The guidelines define PMI as “an increase in the delta of high-sensitivity troponin more than the upper level of normal,” Dr. Mehilli said. “It’s different from the one used in a rule-in algorithm for non-STEMI acute coronary syndrome.”
Postoperative atrial fibrillation (AFib) is observed in 2%-30% of noncardiac surgery patients in different registries, particularly in patients undergoing intermediate or high-risk noncardiac surgery, she noted.
“We propose an algorithm on how to prevent and treat this complication. I want to highlight that in patients with hemodynamic unstable postoperative AF[ib], an emergency cardioversion is indicated. For the others, a rate control with the target heart rate of less than 110 beats per minute is indicated.”
In patients with postoperative AFib, long-term oral anticoagulation therapy should be considered in all patients at risk for stroke, considering the anticipated net clinical benefit of oral anticoagulation therapy as well as informed patient preference (new recommendations).
Routine use of beta-blockers to prevent postoperative AFib in patients undergoing noncardiac surgery is not recommended.
The document also covers the management of patients with kidney disease, diabetes, cancer, obesity, and COVID-19. In general, elective noncardiac surgery should be postponed after a patient has COVID-19, until he or she recovers completely, and coexisting conditions are optimized.
The guidelines are available from the ESC website in several formats: pocket guidelines, pocket guidelines smartphone app, guidelines slide set, essential messages, and the European Heart Journal article.
Noncardiac surgery risk categories
The guideline includes a table that classifies noncardiac surgeries into three groups, based on the associated 30-day risk of death, MI, or stroke:
- Low (< 1%): breast, dental, eye, thyroid, and minor gynecologic, orthopedic, and urologic surgery.
- Intermediate (1%-5%): carotid surgery, endovascular aortic aneurysm repair, gallbladder surgery, head or neck surgery, hernia repair, peripheral arterial angioplasty, renal transplant, major gynecologic, orthopedic, or neurologic (hip or spine) surgery, or urologic surgery
- High (> 5%): aortic and major vascular surgery (including aortic aneurysm), bladder removal (usually as a result of cancer), limb amputation, lung or liver transplant, pancreatic surgery, or perforated bowel repair.
The guidelines were endorsed by the European Society of Anaesthesiology and Intensive Care. The guideline authors reported numerous disclosures.
A version of this article first appeared on Medscape.com.
The European Society of Cardiology guidelines on cardiovascular assessment and management of patients undergoing noncardiac surgery have seen extensive revision since the 2014 version.
They still have the same aim – to prevent surgery-related bleeding complications, perioperative myocardial infarction/injury (PMI), stent thrombosis, acute heart failure, arrhythmias, pulmonary embolism, ischemic stroke, and cardiovascular (CV) death.
Cochairpersons Sigrun Halvorsen, MD, PhD, and Julinda Mehilli, MD, presented highlights from the guidelines at the annual congress of the European Society of Cardiology and the document was simultaneously published online in the European Heart Journal.
The document classifies noncardiac surgery into three levels of 30-day risk of CV death, MI, or stroke. Low (< 1%) risk includes eye or thyroid surgery; intermediate (1%-5%) risk includes knee or hip replacement or renal transplant; and high (> 5%) risk includes aortic aneurysm, lung transplant, or pancreatic or bladder cancer surgery (see more examples below).
It classifies patients as low risk if they are younger than 65 without CV disease or CV risk factors (smoking, hypertension, diabetes, dyslipidemia, family history); intermediate risk if they are 65 or older or have CV risk factors; and high risk if they have CVD.
In an interview, Dr. Halvorsen, professor in cardiology, University of Oslo, zeroed in on three important revisions:
First, recommendations for preoperative ECG and biomarkers are more specific, he noted.
The guidelines advise that before intermediate- or high-risk noncardiac surgery, in patients who have known CVD, CV risk factors (including age 65 or older), or symptoms suggestive of CVD:
- It is recommended to obtain a preoperative 12-lead ECG (class I).
- It is recommended to measure high-sensitivity cardiac troponin T (hs-cTn T) or high-sensitivity cardiac troponin I (hs-cTn I). It is also recommended to measure these biomarkers at 24 hours and 48 hours post surgery (class I).
- It should be considered to measure B-type natriuretic peptide or N-terminal of the prohormone BNP (NT-proBNP).
However, for low-risk patients undergoing low- and intermediate-risk noncardiac surgery, it is not recommended to routinely obtain preoperative ECG, hs-cTn T/I, or BNP/NT-proBNP concentrations (class III).
Troponins have a stronger class I recommendation, compared with the IIA recommendation for BNP, because they are useful for preoperative risk stratification and for diagnosis of PMI, Dr. Halvorsen explained. “Patients receive painkillers after surgery and may have no pain,” she noted, but they may have PMI, which has a bad prognosis.
Second, the guidelines recommend that “all patients should stop smoking 4 weeks before noncardiac surgery [class I],” she noted. Clinicians should also “measure hemoglobin, and if the patient is anemic, treat the anemia.”
Third, the sections on antithrombotic treatment have been significantly revised. “Bridging – stopping an oral antithrombotic drug and switching to a subcutaneous or IV drug – has been common,” Dr. Halvorsen said, “but recently we have new evidence that in most cases that increases the risk of bleeding.”
“We are [now] much more restrictive with respect to bridging” with unfractionated heparin or low-molecular-weight heparin, she said. “We recommend against bridging in patients with low to moderate thrombotic risk,” and bridging should only be considered in patients with mechanical prosthetic heart valves or with very high thrombotic risk.
More preoperative recommendations
In the guideline overview session at the congress, Dr. Halverson highlighted some of the new recommendations for preoperative risk assessment.
If time allows, it is recommended to optimize guideline-recommended treatment of CVD and control of CV risk factors including blood pressure, dyslipidemia, and diabetes, before noncardiac surgery (class I).
Patients commonly have “murmurs, chest pain, dyspnea, and edema that may suggest severe CVD, but may also be caused by noncardiac disease,” she noted. The guidelines state that “for patients with a newly detected murmur and symptoms or signs of CVD, transthoracic echocardiography is recommended before noncardiac surgery (class I).
“Many studies have been performed to try to find out if initiation of specific drugs before surgery could reduce the risk of complications,” Dr. Halvorsen noted. However, few have shown any benefit and “the question of presurgery initiation of beta-blockers has been greatly debated,” she said. “We have again reviewed the literature and concluded ‘Routine initiation of beta-blockers perioperatively is not recommended (class IIIA).’ “
“We adhere to the guidelines on acute and chronic coronary syndrome recommending 6-12 months of dual antiplatelet treatment as a standard before elective surgery,” she said. “However, in case of time-sensitive surgery, the duration of that treatment can be shortened down to a minimum of 1 month after elective PCI and a minimum of 3 months after PCI and ACS.”
Patients with specific types of CVD
Dr. Mehilli, a professor at Landshut-Achdorf (Germany) Hospital, highlighted some new guideline recommendations for patients who have specific types of cardiovascular disease.
Coronary artery disease (CAD). “For chronic coronary syndrome, a cardiac workup is recommended only for patients undergoing intermediate risk or high-risk noncardiac surgery.”
“Stress imaging should be considered before any high risk, noncardiac surgery in asymptomatic patients with poor functional capacity and prior PCI or coronary artery bypass graft (new recommendation, class IIa).”
Mitral valve regurgitation. For patients undergoing scheduled noncardiac surgery, who remain symptomatic despite guideline-directed medical treatment for mitral valve regurgitation (including resynchronization and myocardial revascularization), consider a valve intervention – either transcatheter or surgical – before noncardiac surgery in eligible patients with acceptable procedural risk (new recommendation).
Cardiac implantable electronic devices (CIED). For high-risk patients with CIEDs undergoing noncardiac surgery with high probability of electromagnetic interference, a CIED checkup and necessary reprogramming immediately before the procedure should be considered (new recommendation).
Arrhythmias. “I want only to stress,” Dr. Mehilli said, “in patients with atrial fibrillation with acute or worsening hemodynamic instability undergoing noncardiac surgery, an emergency electrical cardioversion is recommended (class I).”
Peripheral artery disease (PAD) and abdominal aortic aneurysm. For these patients “we do not recommend a routine referral for a cardiac workup. But we recommend it for patients with poor functional capacity or with significant risk factors or symptoms (new recommendations).”
Chronic arterial hypertension. “We have modified the recommendation, recommending avoidance of large perioperative fluctuations in blood pressure, and we do not recommend deferring noncardiac surgery in patients with stage 1 or 2 hypertension,” she said.
Postoperative cardiovascular complications
The most frequent postoperative cardiovascular complication is PMI, Dr. Mehilli noted.
“In the BASEL-PMI registry, the incidence of this complication around intermediate or high-risk noncardiac surgery was up to 15% among patients older than 65 years or with a history of CAD or PAD, which makes this kind of complication really important to prevent, to assess, and to know how to treat.”
“It is recommended to have a high awareness for perioperative cardiovascular complications, combined with surveillance for PMI in patients undergoing intermediate- or high-risk noncardiac surgery” based on serial measurements of high-sensitivity cardiac troponin.
The guidelines define PMI as “an increase in the delta of high-sensitivity troponin more than the upper level of normal,” Dr. Mehilli said. “It’s different from the one used in a rule-in algorithm for non-STEMI acute coronary syndrome.”
Postoperative atrial fibrillation (AFib) is observed in 2%-30% of noncardiac surgery patients in different registries, particularly in patients undergoing intermediate or high-risk noncardiac surgery, she noted.
“We propose an algorithm on how to prevent and treat this complication. I want to highlight that in patients with hemodynamic unstable postoperative AF[ib], an emergency cardioversion is indicated. For the others, a rate control with the target heart rate of less than 110 beats per minute is indicated.”
In patients with postoperative AFib, long-term oral anticoagulation therapy should be considered in all patients at risk for stroke, considering the anticipated net clinical benefit of oral anticoagulation therapy as well as informed patient preference (new recommendations).
Routine use of beta-blockers to prevent postoperative AFib in patients undergoing noncardiac surgery is not recommended.
The document also covers the management of patients with kidney disease, diabetes, cancer, obesity, and COVID-19. In general, elective noncardiac surgery should be postponed after a patient has COVID-19, until he or she recovers completely, and coexisting conditions are optimized.
The guidelines are available from the ESC website in several formats: pocket guidelines, pocket guidelines smartphone app, guidelines slide set, essential messages, and the European Heart Journal article.
Noncardiac surgery risk categories
The guideline includes a table that classifies noncardiac surgeries into three groups, based on the associated 30-day risk of death, MI, or stroke:
- Low (< 1%): breast, dental, eye, thyroid, and minor gynecologic, orthopedic, and urologic surgery.
- Intermediate (1%-5%): carotid surgery, endovascular aortic aneurysm repair, gallbladder surgery, head or neck surgery, hernia repair, peripheral arterial angioplasty, renal transplant, major gynecologic, orthopedic, or neurologic (hip or spine) surgery, or urologic surgery
- High (> 5%): aortic and major vascular surgery (including aortic aneurysm), bladder removal (usually as a result of cancer), limb amputation, lung or liver transplant, pancreatic surgery, or perforated bowel repair.
The guidelines were endorsed by the European Society of Anaesthesiology and Intensive Care. The guideline authors reported numerous disclosures.
A version of this article first appeared on Medscape.com.
The European Society of Cardiology guidelines on cardiovascular assessment and management of patients undergoing noncardiac surgery have seen extensive revision since the 2014 version.
They still have the same aim – to prevent surgery-related bleeding complications, perioperative myocardial infarction/injury (PMI), stent thrombosis, acute heart failure, arrhythmias, pulmonary embolism, ischemic stroke, and cardiovascular (CV) death.
Cochairpersons Sigrun Halvorsen, MD, PhD, and Julinda Mehilli, MD, presented highlights from the guidelines at the annual congress of the European Society of Cardiology and the document was simultaneously published online in the European Heart Journal.
The document classifies noncardiac surgery into three levels of 30-day risk of CV death, MI, or stroke. Low (< 1%) risk includes eye or thyroid surgery; intermediate (1%-5%) risk includes knee or hip replacement or renal transplant; and high (> 5%) risk includes aortic aneurysm, lung transplant, or pancreatic or bladder cancer surgery (see more examples below).
It classifies patients as low risk if they are younger than 65 without CV disease or CV risk factors (smoking, hypertension, diabetes, dyslipidemia, family history); intermediate risk if they are 65 or older or have CV risk factors; and high risk if they have CVD.
In an interview, Dr. Halvorsen, professor in cardiology, University of Oslo, zeroed in on three important revisions:
First, recommendations for preoperative ECG and biomarkers are more specific, he noted.
The guidelines advise that before intermediate- or high-risk noncardiac surgery, in patients who have known CVD, CV risk factors (including age 65 or older), or symptoms suggestive of CVD:
- It is recommended to obtain a preoperative 12-lead ECG (class I).
- It is recommended to measure high-sensitivity cardiac troponin T (hs-cTn T) or high-sensitivity cardiac troponin I (hs-cTn I). It is also recommended to measure these biomarkers at 24 hours and 48 hours post surgery (class I).
- It should be considered to measure B-type natriuretic peptide or N-terminal of the prohormone BNP (NT-proBNP).
However, for low-risk patients undergoing low- and intermediate-risk noncardiac surgery, it is not recommended to routinely obtain preoperative ECG, hs-cTn T/I, or BNP/NT-proBNP concentrations (class III).
Troponins have a stronger class I recommendation, compared with the IIA recommendation for BNP, because they are useful for preoperative risk stratification and for diagnosis of PMI, Dr. Halvorsen explained. “Patients receive painkillers after surgery and may have no pain,” she noted, but they may have PMI, which has a bad prognosis.
Second, the guidelines recommend that “all patients should stop smoking 4 weeks before noncardiac surgery [class I],” she noted. Clinicians should also “measure hemoglobin, and if the patient is anemic, treat the anemia.”
Third, the sections on antithrombotic treatment have been significantly revised. “Bridging – stopping an oral antithrombotic drug and switching to a subcutaneous or IV drug – has been common,” Dr. Halvorsen said, “but recently we have new evidence that in most cases that increases the risk of bleeding.”
“We are [now] much more restrictive with respect to bridging” with unfractionated heparin or low-molecular-weight heparin, she said. “We recommend against bridging in patients with low to moderate thrombotic risk,” and bridging should only be considered in patients with mechanical prosthetic heart valves or with very high thrombotic risk.
More preoperative recommendations
In the guideline overview session at the congress, Dr. Halverson highlighted some of the new recommendations for preoperative risk assessment.
If time allows, it is recommended to optimize guideline-recommended treatment of CVD and control of CV risk factors including blood pressure, dyslipidemia, and diabetes, before noncardiac surgery (class I).
Patients commonly have “murmurs, chest pain, dyspnea, and edema that may suggest severe CVD, but may also be caused by noncardiac disease,” she noted. The guidelines state that “for patients with a newly detected murmur and symptoms or signs of CVD, transthoracic echocardiography is recommended before noncardiac surgery (class I).
“Many studies have been performed to try to find out if initiation of specific drugs before surgery could reduce the risk of complications,” Dr. Halvorsen noted. However, few have shown any benefit and “the question of presurgery initiation of beta-blockers has been greatly debated,” she said. “We have again reviewed the literature and concluded ‘Routine initiation of beta-blockers perioperatively is not recommended (class IIIA).’ “
“We adhere to the guidelines on acute and chronic coronary syndrome recommending 6-12 months of dual antiplatelet treatment as a standard before elective surgery,” she said. “However, in case of time-sensitive surgery, the duration of that treatment can be shortened down to a minimum of 1 month after elective PCI and a minimum of 3 months after PCI and ACS.”
Patients with specific types of CVD
Dr. Mehilli, a professor at Landshut-Achdorf (Germany) Hospital, highlighted some new guideline recommendations for patients who have specific types of cardiovascular disease.
Coronary artery disease (CAD). “For chronic coronary syndrome, a cardiac workup is recommended only for patients undergoing intermediate risk or high-risk noncardiac surgery.”
“Stress imaging should be considered before any high risk, noncardiac surgery in asymptomatic patients with poor functional capacity and prior PCI or coronary artery bypass graft (new recommendation, class IIa).”
Mitral valve regurgitation. For patients undergoing scheduled noncardiac surgery, who remain symptomatic despite guideline-directed medical treatment for mitral valve regurgitation (including resynchronization and myocardial revascularization), consider a valve intervention – either transcatheter or surgical – before noncardiac surgery in eligible patients with acceptable procedural risk (new recommendation).
Cardiac implantable electronic devices (CIED). For high-risk patients with CIEDs undergoing noncardiac surgery with high probability of electromagnetic interference, a CIED checkup and necessary reprogramming immediately before the procedure should be considered (new recommendation).
Arrhythmias. “I want only to stress,” Dr. Mehilli said, “in patients with atrial fibrillation with acute or worsening hemodynamic instability undergoing noncardiac surgery, an emergency electrical cardioversion is recommended (class I).”
Peripheral artery disease (PAD) and abdominal aortic aneurysm. For these patients “we do not recommend a routine referral for a cardiac workup. But we recommend it for patients with poor functional capacity or with significant risk factors or symptoms (new recommendations).”
Chronic arterial hypertension. “We have modified the recommendation, recommending avoidance of large perioperative fluctuations in blood pressure, and we do not recommend deferring noncardiac surgery in patients with stage 1 or 2 hypertension,” she said.
Postoperative cardiovascular complications
The most frequent postoperative cardiovascular complication is PMI, Dr. Mehilli noted.
“In the BASEL-PMI registry, the incidence of this complication around intermediate or high-risk noncardiac surgery was up to 15% among patients older than 65 years or with a history of CAD or PAD, which makes this kind of complication really important to prevent, to assess, and to know how to treat.”
“It is recommended to have a high awareness for perioperative cardiovascular complications, combined with surveillance for PMI in patients undergoing intermediate- or high-risk noncardiac surgery” based on serial measurements of high-sensitivity cardiac troponin.
The guidelines define PMI as “an increase in the delta of high-sensitivity troponin more than the upper level of normal,” Dr. Mehilli said. “It’s different from the one used in a rule-in algorithm for non-STEMI acute coronary syndrome.”
Postoperative atrial fibrillation (AFib) is observed in 2%-30% of noncardiac surgery patients in different registries, particularly in patients undergoing intermediate or high-risk noncardiac surgery, she noted.
“We propose an algorithm on how to prevent and treat this complication. I want to highlight that in patients with hemodynamic unstable postoperative AF[ib], an emergency cardioversion is indicated. For the others, a rate control with the target heart rate of less than 110 beats per minute is indicated.”
In patients with postoperative AFib, long-term oral anticoagulation therapy should be considered in all patients at risk for stroke, considering the anticipated net clinical benefit of oral anticoagulation therapy as well as informed patient preference (new recommendations).
Routine use of beta-blockers to prevent postoperative AFib in patients undergoing noncardiac surgery is not recommended.
The document also covers the management of patients with kidney disease, diabetes, cancer, obesity, and COVID-19. In general, elective noncardiac surgery should be postponed after a patient has COVID-19, until he or she recovers completely, and coexisting conditions are optimized.
The guidelines are available from the ESC website in several formats: pocket guidelines, pocket guidelines smartphone app, guidelines slide set, essential messages, and the European Heart Journal article.
Noncardiac surgery risk categories
The guideline includes a table that classifies noncardiac surgeries into three groups, based on the associated 30-day risk of death, MI, or stroke:
- Low (< 1%): breast, dental, eye, thyroid, and minor gynecologic, orthopedic, and urologic surgery.
- Intermediate (1%-5%): carotid surgery, endovascular aortic aneurysm repair, gallbladder surgery, head or neck surgery, hernia repair, peripheral arterial angioplasty, renal transplant, major gynecologic, orthopedic, or neurologic (hip or spine) surgery, or urologic surgery
- High (> 5%): aortic and major vascular surgery (including aortic aneurysm), bladder removal (usually as a result of cancer), limb amputation, lung or liver transplant, pancreatic surgery, or perforated bowel repair.
The guidelines were endorsed by the European Society of Anaesthesiology and Intensive Care. The guideline authors reported numerous disclosures.
A version of this article first appeared on Medscape.com.
FROM ESC CONGRESS 2022
An Open-Label Feasibility and Acceptability Pilot of Hypnosis and Mindfulness Meditation for Cancer Pain in Veterans
Purpose
This was an open label trial to determine feasibility and acceptability of 2 complementary and integrative interventions (self-hypnosis [HYP] and mindfulness meditation [MM]) for pain in veterans undergoing treatment for head and neck cancer (HNC) at VA Puget Sound.
Background
HNC is associated with pain prior to and during treatment. HYP and MM have shown promise for procedural, acute, and chronic pain and may be a helpful addition to cancer treatment.
Methods
All veterans initiating treatment during the study window (2018-2020) were offered study treatment in addition to usual care. After providing informed consent and hearing a brief description of the interventions, participants selected either the HYP or MM intervention or a control condition (ie, complete assessments but no intervention). Participants met with a study clinician who introduced the intervention and provided audio recordings and a workbook and instructed them to listen to the recordings as often as they deemed helpful. Participants completed survey assessments at baseline, week 4, and at study completion (8 weeks). Measures included patient-reported satisfaction and perceived treatment helpfulness, frequency of practice, and likeliness of using skills going forward.
Data Analysis
Descriptive statistics were computed for all measures collected. No statistical tests were conducted due to small sample size.
Results
Of the 15 veterans who enrolled, 7 selected HYP, 7 selected MM, none selected the control condition, and 1 withdrew prior to treatment selection. Of the 14 completers, 79% reported that their chosen treatment was helpful and that they practiced at least once a week; 71% reported that they are likely to use these skills going forward. No adverse events were reported.
Conclusions/Implications
Self-guided HYP and MM interventions can be administered feasibly and are highly acceptable to veterans undergoing HNC treatment in a VA setting. HYP or MM interventions are feasible to implement with little demand on resources, and that listening to recordings is acceptable and helpful for veterans with pain related to cancer and cancer treatment. Further research is warranted to formally evaluate the efficacy of these interventions in this population in a well-powered study.
Purpose
This was an open label trial to determine feasibility and acceptability of 2 complementary and integrative interventions (self-hypnosis [HYP] and mindfulness meditation [MM]) for pain in veterans undergoing treatment for head and neck cancer (HNC) at VA Puget Sound.
Background
HNC is associated with pain prior to and during treatment. HYP and MM have shown promise for procedural, acute, and chronic pain and may be a helpful addition to cancer treatment.
Methods
All veterans initiating treatment during the study window (2018-2020) were offered study treatment in addition to usual care. After providing informed consent and hearing a brief description of the interventions, participants selected either the HYP or MM intervention or a control condition (ie, complete assessments but no intervention). Participants met with a study clinician who introduced the intervention and provided audio recordings and a workbook and instructed them to listen to the recordings as often as they deemed helpful. Participants completed survey assessments at baseline, week 4, and at study completion (8 weeks). Measures included patient-reported satisfaction and perceived treatment helpfulness, frequency of practice, and likeliness of using skills going forward.
Data Analysis
Descriptive statistics were computed for all measures collected. No statistical tests were conducted due to small sample size.
Results
Of the 15 veterans who enrolled, 7 selected HYP, 7 selected MM, none selected the control condition, and 1 withdrew prior to treatment selection. Of the 14 completers, 79% reported that their chosen treatment was helpful and that they practiced at least once a week; 71% reported that they are likely to use these skills going forward. No adverse events were reported.
Conclusions/Implications
Self-guided HYP and MM interventions can be administered feasibly and are highly acceptable to veterans undergoing HNC treatment in a VA setting. HYP or MM interventions are feasible to implement with little demand on resources, and that listening to recordings is acceptable and helpful for veterans with pain related to cancer and cancer treatment. Further research is warranted to formally evaluate the efficacy of these interventions in this population in a well-powered study.
Purpose
This was an open label trial to determine feasibility and acceptability of 2 complementary and integrative interventions (self-hypnosis [HYP] and mindfulness meditation [MM]) for pain in veterans undergoing treatment for head and neck cancer (HNC) at VA Puget Sound.
Background
HNC is associated with pain prior to and during treatment. HYP and MM have shown promise for procedural, acute, and chronic pain and may be a helpful addition to cancer treatment.
Methods
All veterans initiating treatment during the study window (2018-2020) were offered study treatment in addition to usual care. After providing informed consent and hearing a brief description of the interventions, participants selected either the HYP or MM intervention or a control condition (ie, complete assessments but no intervention). Participants met with a study clinician who introduced the intervention and provided audio recordings and a workbook and instructed them to listen to the recordings as often as they deemed helpful. Participants completed survey assessments at baseline, week 4, and at study completion (8 weeks). Measures included patient-reported satisfaction and perceived treatment helpfulness, frequency of practice, and likeliness of using skills going forward.
Data Analysis
Descriptive statistics were computed for all measures collected. No statistical tests were conducted due to small sample size.
Results
Of the 15 veterans who enrolled, 7 selected HYP, 7 selected MM, none selected the control condition, and 1 withdrew prior to treatment selection. Of the 14 completers, 79% reported that their chosen treatment was helpful and that they practiced at least once a week; 71% reported that they are likely to use these skills going forward. No adverse events were reported.
Conclusions/Implications
Self-guided HYP and MM interventions can be administered feasibly and are highly acceptable to veterans undergoing HNC treatment in a VA setting. HYP or MM interventions are feasible to implement with little demand on resources, and that listening to recordings is acceptable and helpful for veterans with pain related to cancer and cancer treatment. Further research is warranted to formally evaluate the efficacy of these interventions in this population in a well-powered study.
The Use of Aromatherapy as a Complementary Alternative Medicine in the Management of Cancer-Related Pain
Purpose
To identify the effectiveness of aromatherapy as an adjunct in improving pain and overall sense of well-being among patients with cancer receiving hospice care.
Background
There is limited data available on the use of aromatherapy for pain management among patients with cancer receiving end-of-life care. This project identifies the benefits of aromatherapy in a population where it was not previously evaluated.
Methods
Patients with cancer who were admitted to the hospice unit of a local hospital within a large healthcare system for at least 24 hours and taking opioids for neoplasm related pain at least once a day were included in the study. Patients with allergy to essential oils, and those suffering from allergic rhinitis and common cold, and a history of asthma were excluded. Patients who were unable to consent for study participation were also excluded.
Data Analysis
Retrospective chart analysis and surveys were used to collect the data. Univariate descriptive statistics were used for patient characteristics. A Wilcoxon Signed Rank Test was used to determine opioid use before and after aromatherapy. The t test was used to compare pain scores before and after aromatherapy. A 5-point Likert scale was used to evaluate how soothing the participants found the treatment to be. The Numeric Pain Intensity Scale was used for pain scores.
Results
There was a total of 40 participants, all of whom were male with an average age of 69 years. Pain scores before and after treatment were found to be statistically significant at an average of 5.15/10 vs 3.68/10, respectively. On a scale from 1-5 with 5 being the most soothing, there was an average rating of 3.87 among participants. There was not a statistically significant decline in opioid use from pre-treatment to post-treatment. Higher pain scores before intervention were associated with rating the lotion as more soothing.
Conclusions
The use of aromatherapy as a complement to opioids for cancer-related pain in the end-of-life was associated with an increase sense of well-being, resulted in lower pain scores and seems to have subjective comfort merit.
Implications
This study shows the potential benefits of using aromatherapy in end-of-life care among patients with cancer.
Purpose
To identify the effectiveness of aromatherapy as an adjunct in improving pain and overall sense of well-being among patients with cancer receiving hospice care.
Background
There is limited data available on the use of aromatherapy for pain management among patients with cancer receiving end-of-life care. This project identifies the benefits of aromatherapy in a population where it was not previously evaluated.
Methods
Patients with cancer who were admitted to the hospice unit of a local hospital within a large healthcare system for at least 24 hours and taking opioids for neoplasm related pain at least once a day were included in the study. Patients with allergy to essential oils, and those suffering from allergic rhinitis and common cold, and a history of asthma were excluded. Patients who were unable to consent for study participation were also excluded.
Data Analysis
Retrospective chart analysis and surveys were used to collect the data. Univariate descriptive statistics were used for patient characteristics. A Wilcoxon Signed Rank Test was used to determine opioid use before and after aromatherapy. The t test was used to compare pain scores before and after aromatherapy. A 5-point Likert scale was used to evaluate how soothing the participants found the treatment to be. The Numeric Pain Intensity Scale was used for pain scores.
Results
There was a total of 40 participants, all of whom were male with an average age of 69 years. Pain scores before and after treatment were found to be statistically significant at an average of 5.15/10 vs 3.68/10, respectively. On a scale from 1-5 with 5 being the most soothing, there was an average rating of 3.87 among participants. There was not a statistically significant decline in opioid use from pre-treatment to post-treatment. Higher pain scores before intervention were associated with rating the lotion as more soothing.
Conclusions
The use of aromatherapy as a complement to opioids for cancer-related pain in the end-of-life was associated with an increase sense of well-being, resulted in lower pain scores and seems to have subjective comfort merit.
Implications
This study shows the potential benefits of using aromatherapy in end-of-life care among patients with cancer.
Purpose
To identify the effectiveness of aromatherapy as an adjunct in improving pain and overall sense of well-being among patients with cancer receiving hospice care.
Background
There is limited data available on the use of aromatherapy for pain management among patients with cancer receiving end-of-life care. This project identifies the benefits of aromatherapy in a population where it was not previously evaluated.
Methods
Patients with cancer who were admitted to the hospice unit of a local hospital within a large healthcare system for at least 24 hours and taking opioids for neoplasm related pain at least once a day were included in the study. Patients with allergy to essential oils, and those suffering from allergic rhinitis and common cold, and a history of asthma were excluded. Patients who were unable to consent for study participation were also excluded.
Data Analysis
Retrospective chart analysis and surveys were used to collect the data. Univariate descriptive statistics were used for patient characteristics. A Wilcoxon Signed Rank Test was used to determine opioid use before and after aromatherapy. The t test was used to compare pain scores before and after aromatherapy. A 5-point Likert scale was used to evaluate how soothing the participants found the treatment to be. The Numeric Pain Intensity Scale was used for pain scores.
Results
There was a total of 40 participants, all of whom were male with an average age of 69 years. Pain scores before and after treatment were found to be statistically significant at an average of 5.15/10 vs 3.68/10, respectively. On a scale from 1-5 with 5 being the most soothing, there was an average rating of 3.87 among participants. There was not a statistically significant decline in opioid use from pre-treatment to post-treatment. Higher pain scores before intervention were associated with rating the lotion as more soothing.
Conclusions
The use of aromatherapy as a complement to opioids for cancer-related pain in the end-of-life was associated with an increase sense of well-being, resulted in lower pain scores and seems to have subjective comfort merit.
Implications
This study shows the potential benefits of using aromatherapy in end-of-life care among patients with cancer.
Waldenstrom Macroglobulinemia Presenting With Schnitzler Syndrome
Background
Schnitzler syndrome is a rare, auto-inflammatory syndrome associated with IgM monoclonal gammopathy that manifests as a non-pruritic urticarial rash. Patients may also have intermittent fevers, lymphadenopathy, bone pain, and arthralgias. Given its rarity and nonspecific presentation, its diagnosis requires a high index of clinical suspicion. Herein, we describe a case of a patient with a 2-year history of urticarial rash who then developed fevers, arthralgias, neutrophilia, and weight loss. He was ultimately found to have a diagnosis of Waldenstrom Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL), in the context of Schnitzler Syndrome.
Case Report
A 74-year-old traveling veteran presenting with fatigue, weight loss, arthralgias and rash was found to have anemia and leukocytosis concerning an occult hematologic malignancy. On exam, his rash appeared classically urticarial. He described the rash as nonpruritic and ‘waxing and waning’ for ~18 months. Following the rash, he developed drenching night sweats which progressively worsened over the last 4 months. This was accompanied by fatigue and arthralgias. On review of his labs, he had a normocytic anemia, thrombocytosis and progressive neutrophilia of approximately 20,000 over the last 4 months. Peripheral blood smear was remarkable for atypical lymphocytes. Peripheral blood flow cytometry revealed a small monoclonal CD5-/CD10- B-cell population of uncertain significance. His total serum IgM level was > 1000 mg/dL and serum protein electrophoresis with IFE confirmed a monoclonal IgM gammopathy with M-spike of 0.99 g/dL.
Results
A bone marrow biopsy showed a hypercellular marrow with LPL comprising 50%-60% of the cellularity. It was also notable for grade 1/3 reticulin fibrosis and mild megakaryocytic aty WM/LPL can have a heterogeneous presentation. Urticarial rash, constitutional symptoms, joint pain, and neutrophilia should raise suspicion for Schnitzler syndrome, especially in conjunction with IgM monoclonal gammopathy. This rare syndrome is imperative to consider because it can be treated quickly with high efficacy with IL-1 antagonism. Anakinra is clinically effective for symptom management while awaiting primary treatment for underlying LPL.
Background
Schnitzler syndrome is a rare, auto-inflammatory syndrome associated with IgM monoclonal gammopathy that manifests as a non-pruritic urticarial rash. Patients may also have intermittent fevers, lymphadenopathy, bone pain, and arthralgias. Given its rarity and nonspecific presentation, its diagnosis requires a high index of clinical suspicion. Herein, we describe a case of a patient with a 2-year history of urticarial rash who then developed fevers, arthralgias, neutrophilia, and weight loss. He was ultimately found to have a diagnosis of Waldenstrom Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL), in the context of Schnitzler Syndrome.
Case Report
A 74-year-old traveling veteran presenting with fatigue, weight loss, arthralgias and rash was found to have anemia and leukocytosis concerning an occult hematologic malignancy. On exam, his rash appeared classically urticarial. He described the rash as nonpruritic and ‘waxing and waning’ for ~18 months. Following the rash, he developed drenching night sweats which progressively worsened over the last 4 months. This was accompanied by fatigue and arthralgias. On review of his labs, he had a normocytic anemia, thrombocytosis and progressive neutrophilia of approximately 20,000 over the last 4 months. Peripheral blood smear was remarkable for atypical lymphocytes. Peripheral blood flow cytometry revealed a small monoclonal CD5-/CD10- B-cell population of uncertain significance. His total serum IgM level was > 1000 mg/dL and serum protein electrophoresis with IFE confirmed a monoclonal IgM gammopathy with M-spike of 0.99 g/dL.
Results
A bone marrow biopsy showed a hypercellular marrow with LPL comprising 50%-60% of the cellularity. It was also notable for grade 1/3 reticulin fibrosis and mild megakaryocytic aty WM/LPL can have a heterogeneous presentation. Urticarial rash, constitutional symptoms, joint pain, and neutrophilia should raise suspicion for Schnitzler syndrome, especially in conjunction with IgM monoclonal gammopathy. This rare syndrome is imperative to consider because it can be treated quickly with high efficacy with IL-1 antagonism. Anakinra is clinically effective for symptom management while awaiting primary treatment for underlying LPL.
Background
Schnitzler syndrome is a rare, auto-inflammatory syndrome associated with IgM monoclonal gammopathy that manifests as a non-pruritic urticarial rash. Patients may also have intermittent fevers, lymphadenopathy, bone pain, and arthralgias. Given its rarity and nonspecific presentation, its diagnosis requires a high index of clinical suspicion. Herein, we describe a case of a patient with a 2-year history of urticarial rash who then developed fevers, arthralgias, neutrophilia, and weight loss. He was ultimately found to have a diagnosis of Waldenstrom Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL), in the context of Schnitzler Syndrome.
Case Report
A 74-year-old traveling veteran presenting with fatigue, weight loss, arthralgias and rash was found to have anemia and leukocytosis concerning an occult hematologic malignancy. On exam, his rash appeared classically urticarial. He described the rash as nonpruritic and ‘waxing and waning’ for ~18 months. Following the rash, he developed drenching night sweats which progressively worsened over the last 4 months. This was accompanied by fatigue and arthralgias. On review of his labs, he had a normocytic anemia, thrombocytosis and progressive neutrophilia of approximately 20,000 over the last 4 months. Peripheral blood smear was remarkable for atypical lymphocytes. Peripheral blood flow cytometry revealed a small monoclonal CD5-/CD10- B-cell population of uncertain significance. His total serum IgM level was > 1000 mg/dL and serum protein electrophoresis with IFE confirmed a monoclonal IgM gammopathy with M-spike of 0.99 g/dL.
Results
A bone marrow biopsy showed a hypercellular marrow with LPL comprising 50%-60% of the cellularity. It was also notable for grade 1/3 reticulin fibrosis and mild megakaryocytic aty WM/LPL can have a heterogeneous presentation. Urticarial rash, constitutional symptoms, joint pain, and neutrophilia should raise suspicion for Schnitzler syndrome, especially in conjunction with IgM monoclonal gammopathy. This rare syndrome is imperative to consider because it can be treated quickly with high efficacy with IL-1 antagonism. Anakinra is clinically effective for symptom management while awaiting primary treatment for underlying LPL.
Cannabis for pain linked to slight risk for arrhythmia
Patients who received a first prescription for medicinal cannabis for chronic pain were more likely to have new onset of arrhythmia – bradyarrhythmia, tachyarrhythmia, or a conduction disorder – within 6 months than were similar nonusers, in a new case-control study.
There were no between-group differences in the incidence of heart failure or acute coronary syndrome.
The researchers identified 5,071 patients in a national Danish registry who had filled at least one prescription for medicinal cannabis for chronic pain and matched each patient with five patients of the same sex, age range, and type of chronic pain who did not receive this therapy.
The relative risk for arrhythmia was 83% higher in those who used medicinal cannabis than it was in the other patients, study author Nina Nouhravesh, MD, told this news organization in an email.
However, the absolute risks for arrhythmia were slight – a 0.86% risk (95% confidence interval, 0.61%-1.1%) in medicinal cannabis users versus a 0.47% risk (95% CI, 0.38%-0.56%) in those who did not use medicinal cannabis.
“Since medical cannabis is a relatively new drug for a large market of patients with chronic pain, it is important to investigate and report serious side effects,” said Dr. Nouhravesh, from Gentofte University Hospital, Denmark.
The study results, she said, suggest that “there may be a previously unreported risk of arrhythmias following medical cannabis use.”
“Even though the absolute risk difference is small, both patients and physicians should have as much information as possible when weighing up the pros and cons of any treatment,” Dr. Nouhravesh said, adding that “the findings of this study raise concerns for both legal and illegal [cannabis] use worldwide.”
The results will be presented at the annual European Society of Cardiology (ESC) Congress 2022.
Too soon to tell?
However, Brian Olshansky, MD, who was not involved with this research, cautions that it is important to consider several study limitations before drawing clinical implications.
“Other data and reports have considered the possibility of arrhythmias in relationship to marijuana use, and the data go in both directions,” Dr. Olshansky, a clinical cardiac electrophysiologist and professor emeritus at University of Iowa Hospitals, Iowa City, pointed out in an email.
“Importantly, arrhythmias, by themselves, are not necessarily consequential,” he stressed. “In any case,” he added, the risks in the current study are “extraordinarily small.”
Sinus bradycardia, sinus tachycardia, and premature atrial or ventricular contractions could be totally benign, he said. On the other hand, arrhythmias may indicate the presence of atrial fibrillation, atrial flutter, ventricular tachycardia, and ventricular fibrillation, which are potentially dangerous.
There may be a specific “high risk” group who can develop potentially serious arrhythmias, Dr. Olshansky suggested.
“There is no evidence that any of these patients underwent or required any treatment for their arrhythmia or that stopping or starting the cannabinoids affected the arrhythmia one way or the other,” he said. “In addition, there is no dose/arrhythmia relationship.”
More patients in the medicinal cannabis group than in the nonuser group were also taking opioids (49% vs. 30%), nonsteroidal anti-inflammatory drugs (24% vs. 19%), antiepileptics (35% vs. 23%), or tricyclic antidepressants (11% vs. 4%), he noted.
In summary, according to Dr. Olshansky, “these data pose no obvious health concern and provide no vital knowledge for physicians prescribing cannabis.”
“My concern is that the information will be overblown,” he cautioned. “If the cannabinoid actually has benefit in terms of pain reduction, its use may be mitigated based on the fear of an arrhythmia that may occur – but the risk of an arrhythmia, in any event, is very small and undefined in terms of its seriousness.”
Cancer, musculoskeletal, and neurologic pain
For this analysis, the researchers identified 1.8 million patients in Denmark who were diagnosed with chronic pain between 2018 and 2021.
Of those, around 5,000 patients had claimed at least one prescription of medicinal cannabis (dronabinol 29%, cannabinoids 46%, or cannabidiol 25%).
The patients had a median age of 60 years, and 63% were women.
The cannabis users had been prescribed this therapy for musculoskeletal (35%), cancer (18%), neurological (14%), or other (33%) pain, Dr. Nouhravesh said.
The researchers and Dr. Olshansky have no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Patients who received a first prescription for medicinal cannabis for chronic pain were more likely to have new onset of arrhythmia – bradyarrhythmia, tachyarrhythmia, or a conduction disorder – within 6 months than were similar nonusers, in a new case-control study.
There were no between-group differences in the incidence of heart failure or acute coronary syndrome.
The researchers identified 5,071 patients in a national Danish registry who had filled at least one prescription for medicinal cannabis for chronic pain and matched each patient with five patients of the same sex, age range, and type of chronic pain who did not receive this therapy.
The relative risk for arrhythmia was 83% higher in those who used medicinal cannabis than it was in the other patients, study author Nina Nouhravesh, MD, told this news organization in an email.
However, the absolute risks for arrhythmia were slight – a 0.86% risk (95% confidence interval, 0.61%-1.1%) in medicinal cannabis users versus a 0.47% risk (95% CI, 0.38%-0.56%) in those who did not use medicinal cannabis.
“Since medical cannabis is a relatively new drug for a large market of patients with chronic pain, it is important to investigate and report serious side effects,” said Dr. Nouhravesh, from Gentofte University Hospital, Denmark.
The study results, she said, suggest that “there may be a previously unreported risk of arrhythmias following medical cannabis use.”
“Even though the absolute risk difference is small, both patients and physicians should have as much information as possible when weighing up the pros and cons of any treatment,” Dr. Nouhravesh said, adding that “the findings of this study raise concerns for both legal and illegal [cannabis] use worldwide.”
The results will be presented at the annual European Society of Cardiology (ESC) Congress 2022.
Too soon to tell?
However, Brian Olshansky, MD, who was not involved with this research, cautions that it is important to consider several study limitations before drawing clinical implications.
“Other data and reports have considered the possibility of arrhythmias in relationship to marijuana use, and the data go in both directions,” Dr. Olshansky, a clinical cardiac electrophysiologist and professor emeritus at University of Iowa Hospitals, Iowa City, pointed out in an email.
“Importantly, arrhythmias, by themselves, are not necessarily consequential,” he stressed. “In any case,” he added, the risks in the current study are “extraordinarily small.”
Sinus bradycardia, sinus tachycardia, and premature atrial or ventricular contractions could be totally benign, he said. On the other hand, arrhythmias may indicate the presence of atrial fibrillation, atrial flutter, ventricular tachycardia, and ventricular fibrillation, which are potentially dangerous.
There may be a specific “high risk” group who can develop potentially serious arrhythmias, Dr. Olshansky suggested.
“There is no evidence that any of these patients underwent or required any treatment for their arrhythmia or that stopping or starting the cannabinoids affected the arrhythmia one way or the other,” he said. “In addition, there is no dose/arrhythmia relationship.”
More patients in the medicinal cannabis group than in the nonuser group were also taking opioids (49% vs. 30%), nonsteroidal anti-inflammatory drugs (24% vs. 19%), antiepileptics (35% vs. 23%), or tricyclic antidepressants (11% vs. 4%), he noted.
In summary, according to Dr. Olshansky, “these data pose no obvious health concern and provide no vital knowledge for physicians prescribing cannabis.”
“My concern is that the information will be overblown,” he cautioned. “If the cannabinoid actually has benefit in terms of pain reduction, its use may be mitigated based on the fear of an arrhythmia that may occur – but the risk of an arrhythmia, in any event, is very small and undefined in terms of its seriousness.”
Cancer, musculoskeletal, and neurologic pain
For this analysis, the researchers identified 1.8 million patients in Denmark who were diagnosed with chronic pain between 2018 and 2021.
Of those, around 5,000 patients had claimed at least one prescription of medicinal cannabis (dronabinol 29%, cannabinoids 46%, or cannabidiol 25%).
The patients had a median age of 60 years, and 63% were women.
The cannabis users had been prescribed this therapy for musculoskeletal (35%), cancer (18%), neurological (14%), or other (33%) pain, Dr. Nouhravesh said.
The researchers and Dr. Olshansky have no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Patients who received a first prescription for medicinal cannabis for chronic pain were more likely to have new onset of arrhythmia – bradyarrhythmia, tachyarrhythmia, or a conduction disorder – within 6 months than were similar nonusers, in a new case-control study.
There were no between-group differences in the incidence of heart failure or acute coronary syndrome.
The researchers identified 5,071 patients in a national Danish registry who had filled at least one prescription for medicinal cannabis for chronic pain and matched each patient with five patients of the same sex, age range, and type of chronic pain who did not receive this therapy.
The relative risk for arrhythmia was 83% higher in those who used medicinal cannabis than it was in the other patients, study author Nina Nouhravesh, MD, told this news organization in an email.
However, the absolute risks for arrhythmia were slight – a 0.86% risk (95% confidence interval, 0.61%-1.1%) in medicinal cannabis users versus a 0.47% risk (95% CI, 0.38%-0.56%) in those who did not use medicinal cannabis.
“Since medical cannabis is a relatively new drug for a large market of patients with chronic pain, it is important to investigate and report serious side effects,” said Dr. Nouhravesh, from Gentofte University Hospital, Denmark.
The study results, she said, suggest that “there may be a previously unreported risk of arrhythmias following medical cannabis use.”
“Even though the absolute risk difference is small, both patients and physicians should have as much information as possible when weighing up the pros and cons of any treatment,” Dr. Nouhravesh said, adding that “the findings of this study raise concerns for both legal and illegal [cannabis] use worldwide.”
The results will be presented at the annual European Society of Cardiology (ESC) Congress 2022.
Too soon to tell?
However, Brian Olshansky, MD, who was not involved with this research, cautions that it is important to consider several study limitations before drawing clinical implications.
“Other data and reports have considered the possibility of arrhythmias in relationship to marijuana use, and the data go in both directions,” Dr. Olshansky, a clinical cardiac electrophysiologist and professor emeritus at University of Iowa Hospitals, Iowa City, pointed out in an email.
“Importantly, arrhythmias, by themselves, are not necessarily consequential,” he stressed. “In any case,” he added, the risks in the current study are “extraordinarily small.”
Sinus bradycardia, sinus tachycardia, and premature atrial or ventricular contractions could be totally benign, he said. On the other hand, arrhythmias may indicate the presence of atrial fibrillation, atrial flutter, ventricular tachycardia, and ventricular fibrillation, which are potentially dangerous.
There may be a specific “high risk” group who can develop potentially serious arrhythmias, Dr. Olshansky suggested.
“There is no evidence that any of these patients underwent or required any treatment for their arrhythmia or that stopping or starting the cannabinoids affected the arrhythmia one way or the other,” he said. “In addition, there is no dose/arrhythmia relationship.”
More patients in the medicinal cannabis group than in the nonuser group were also taking opioids (49% vs. 30%), nonsteroidal anti-inflammatory drugs (24% vs. 19%), antiepileptics (35% vs. 23%), or tricyclic antidepressants (11% vs. 4%), he noted.
In summary, according to Dr. Olshansky, “these data pose no obvious health concern and provide no vital knowledge for physicians prescribing cannabis.”
“My concern is that the information will be overblown,” he cautioned. “If the cannabinoid actually has benefit in terms of pain reduction, its use may be mitigated based on the fear of an arrhythmia that may occur – but the risk of an arrhythmia, in any event, is very small and undefined in terms of its seriousness.”
Cancer, musculoskeletal, and neurologic pain
For this analysis, the researchers identified 1.8 million patients in Denmark who were diagnosed with chronic pain between 2018 and 2021.
Of those, around 5,000 patients had claimed at least one prescription of medicinal cannabis (dronabinol 29%, cannabinoids 46%, or cannabidiol 25%).
The patients had a median age of 60 years, and 63% were women.
The cannabis users had been prescribed this therapy for musculoskeletal (35%), cancer (18%), neurological (14%), or other (33%) pain, Dr. Nouhravesh said.
The researchers and Dr. Olshansky have no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
FROM ESC CONGRESS 2022
NSAIDs linked to heart failure risk in diabetes
People with diabetes who take nonsteroidal anti-inflammatory drugs even on a short-term basis may have about a 50% greater risk of developing heart failure, according to results from a national registry study of more than 330,000 patients to be presented at the annual congress of the European Society of Cardiology.
“According to data from this study, even short-term NSAID use – within 28 days – in patients with type 2 diabetes mellitus are associated with an increased risk of first-time heart failure hospitalization,” lead author Anders Holt, MD, said in an interview.
“Further, it seems that patients above 79 years of age or with elevated hemoglobin A1c levels, along with new users of NSAIDs, are particularly susceptible.” He added that no such association was found in patients below age 65 years with normal A1c levels.
Dr. Holt has a dual appointment as a cardiologist at Copenhagen University and Herlev-Gentofte Hospital in Hellerup, Denmark, and the department of epidemiology and biostatistics at the University of Auckland (New Zealand). Jarl Emmanuel Strange, MD, PhD, a fellow at Copenhagen University, is to present the abstract on Aug. 26.
“This is quite an important observation given that, unfortunately, NSAIDs continue to be prescribed rather easily to people with diabetes and these agents do have risk,” said Rodica Busui, MD, PhD, codirector of the JDRF Center of Excellence at the University of Michigan, Ann Arbor, and president-elect for medicine and science of the American Diabetes Association. Dr. Busui is also lead author of an ADA/American College of Cardiology consensus report on heart failure in diabetes.
The study hypothesized that fluid retention “is a known but underappreciated side effect” of NSAID use and that short-term NSAID use could lead to heart failure in patients with type 2 diabetes, which has been linked to subclinical cardiomyopathy and kidney dysfunction.
“According to this study and particularly the subgroups analyses, it seems that incident heart failure associated with short-term NSAID use could be more than ‘just fluid overload,’ ” Dr. Holt said. “Further investigations into the specific mechanisms causing these associations are warranted.”
The study identified 331,189 patients with type 2 diabetes in nationwide Danish registries from 1998 to 2018. Median age was 62 years, and 23,308 (7%) were hospitalized with heart failure during follow-up, Dr. Holt said. Of them, 16% claimed at least one NSAID prescription within 2 years and 3% claimed they had at least three prescriptions.
Study follow-up started 120 days after the first-time type 2 diabetes diagnosis and focused on patients who had no previous diagnosis of heart failure or rheumatologic disease. The investigators reported on patients who had one, two, three or four prescriptions for NSAID within a year of starting follow-up.
The study used a case-crossover design, which, the abstract stated, “uses each individual as his or her own control making it suitable to study the effect of short-term exposure on immediate events while mitigating unmeasured confounding.”
Dr. Holt noted that short-term NSAID use was linked to increased risk of heart failure hospitalization (odds ratio, 1.43; 95% confidence interval, 1.27-1.63). The investigators identified even greater risks in three subgroups: age of at least 80 years (OR, 1.78; 95% CI, 1.39-2.28), elevated A1c levels treated with one or less antidiabetic medication (OR 1.68; 95% CI, 1-2.88), and patients without previous NSAID use (OR, 2.71; 95% CI, 1.78-4.23).
In the cohort, celecoxib and naproxen were rarely used (0.4 and 0.9%, respectively), while 3.3% of patients took diclofenac or 12.2% ibuprofen. The latter two NSAIDs had ORs of 1.48 and 1.46, respectively, for hospitalization for new-onset heart failure using 28-day exposure windows (95% CI for both, 1.1-2 and 1.26-1.69). No increased risk emerged for celecoxib or naproxen.
“High age and A1c levels and being a new user were tied to the strongest associations, along with known use of RASi [renin-angiotensin system inhibitors] and diuretics,” Dr. Holt said. “On the contrary, it seemed safe – from our data – to prescribe short-term NSAIDs for patients below 65 years of age and patients with normal A1c levels.
“Interestingly,” he added, “subclinical structural heart disease among patients with type 2 diabetes could play an important role.”
The findings are noteworthy, Dr. Busui said. “Although there are some limitations with the study design in general when one looks at data extracted from registers, the very large sample size and the fact that the Danish national register captures data in a standardized fashion does make the findings very relevant, especially now that we have confirmed that heart failure is the most prevalent cardiovascular complication in people with diabetes, as we have highlighted in the most recent ADA/ACC consensus on heart failure in diabetes.”
The study received funding from the Danish Heart Foundation and a number of private foundations. Dr. Holt and colleagues have no disclosures. Dr. Busui disclosed relationships with AstraZeneca, Boehringer Ingelheim–Lilly Alliance, Novo Nordisk, Averitas Pharma, Nevro, Regenacy Pharmaceuticals and Roche Diagnostics.
People with diabetes who take nonsteroidal anti-inflammatory drugs even on a short-term basis may have about a 50% greater risk of developing heart failure, according to results from a national registry study of more than 330,000 patients to be presented at the annual congress of the European Society of Cardiology.
“According to data from this study, even short-term NSAID use – within 28 days – in patients with type 2 diabetes mellitus are associated with an increased risk of first-time heart failure hospitalization,” lead author Anders Holt, MD, said in an interview.
“Further, it seems that patients above 79 years of age or with elevated hemoglobin A1c levels, along with new users of NSAIDs, are particularly susceptible.” He added that no such association was found in patients below age 65 years with normal A1c levels.
Dr. Holt has a dual appointment as a cardiologist at Copenhagen University and Herlev-Gentofte Hospital in Hellerup, Denmark, and the department of epidemiology and biostatistics at the University of Auckland (New Zealand). Jarl Emmanuel Strange, MD, PhD, a fellow at Copenhagen University, is to present the abstract on Aug. 26.
“This is quite an important observation given that, unfortunately, NSAIDs continue to be prescribed rather easily to people with diabetes and these agents do have risk,” said Rodica Busui, MD, PhD, codirector of the JDRF Center of Excellence at the University of Michigan, Ann Arbor, and president-elect for medicine and science of the American Diabetes Association. Dr. Busui is also lead author of an ADA/American College of Cardiology consensus report on heart failure in diabetes.
The study hypothesized that fluid retention “is a known but underappreciated side effect” of NSAID use and that short-term NSAID use could lead to heart failure in patients with type 2 diabetes, which has been linked to subclinical cardiomyopathy and kidney dysfunction.
“According to this study and particularly the subgroups analyses, it seems that incident heart failure associated with short-term NSAID use could be more than ‘just fluid overload,’ ” Dr. Holt said. “Further investigations into the specific mechanisms causing these associations are warranted.”
The study identified 331,189 patients with type 2 diabetes in nationwide Danish registries from 1998 to 2018. Median age was 62 years, and 23,308 (7%) were hospitalized with heart failure during follow-up, Dr. Holt said. Of them, 16% claimed at least one NSAID prescription within 2 years and 3% claimed they had at least three prescriptions.
Study follow-up started 120 days after the first-time type 2 diabetes diagnosis and focused on patients who had no previous diagnosis of heart failure or rheumatologic disease. The investigators reported on patients who had one, two, three or four prescriptions for NSAID within a year of starting follow-up.
The study used a case-crossover design, which, the abstract stated, “uses each individual as his or her own control making it suitable to study the effect of short-term exposure on immediate events while mitigating unmeasured confounding.”
Dr. Holt noted that short-term NSAID use was linked to increased risk of heart failure hospitalization (odds ratio, 1.43; 95% confidence interval, 1.27-1.63). The investigators identified even greater risks in three subgroups: age of at least 80 years (OR, 1.78; 95% CI, 1.39-2.28), elevated A1c levels treated with one or less antidiabetic medication (OR 1.68; 95% CI, 1-2.88), and patients without previous NSAID use (OR, 2.71; 95% CI, 1.78-4.23).
In the cohort, celecoxib and naproxen were rarely used (0.4 and 0.9%, respectively), while 3.3% of patients took diclofenac or 12.2% ibuprofen. The latter two NSAIDs had ORs of 1.48 and 1.46, respectively, for hospitalization for new-onset heart failure using 28-day exposure windows (95% CI for both, 1.1-2 and 1.26-1.69). No increased risk emerged for celecoxib or naproxen.
“High age and A1c levels and being a new user were tied to the strongest associations, along with known use of RASi [renin-angiotensin system inhibitors] and diuretics,” Dr. Holt said. “On the contrary, it seemed safe – from our data – to prescribe short-term NSAIDs for patients below 65 years of age and patients with normal A1c levels.
“Interestingly,” he added, “subclinical structural heart disease among patients with type 2 diabetes could play an important role.”
The findings are noteworthy, Dr. Busui said. “Although there are some limitations with the study design in general when one looks at data extracted from registers, the very large sample size and the fact that the Danish national register captures data in a standardized fashion does make the findings very relevant, especially now that we have confirmed that heart failure is the most prevalent cardiovascular complication in people with diabetes, as we have highlighted in the most recent ADA/ACC consensus on heart failure in diabetes.”
The study received funding from the Danish Heart Foundation and a number of private foundations. Dr. Holt and colleagues have no disclosures. Dr. Busui disclosed relationships with AstraZeneca, Boehringer Ingelheim–Lilly Alliance, Novo Nordisk, Averitas Pharma, Nevro, Regenacy Pharmaceuticals and Roche Diagnostics.
People with diabetes who take nonsteroidal anti-inflammatory drugs even on a short-term basis may have about a 50% greater risk of developing heart failure, according to results from a national registry study of more than 330,000 patients to be presented at the annual congress of the European Society of Cardiology.
“According to data from this study, even short-term NSAID use – within 28 days – in patients with type 2 diabetes mellitus are associated with an increased risk of first-time heart failure hospitalization,” lead author Anders Holt, MD, said in an interview.
“Further, it seems that patients above 79 years of age or with elevated hemoglobin A1c levels, along with new users of NSAIDs, are particularly susceptible.” He added that no such association was found in patients below age 65 years with normal A1c levels.
Dr. Holt has a dual appointment as a cardiologist at Copenhagen University and Herlev-Gentofte Hospital in Hellerup, Denmark, and the department of epidemiology and biostatistics at the University of Auckland (New Zealand). Jarl Emmanuel Strange, MD, PhD, a fellow at Copenhagen University, is to present the abstract on Aug. 26.
“This is quite an important observation given that, unfortunately, NSAIDs continue to be prescribed rather easily to people with diabetes and these agents do have risk,” said Rodica Busui, MD, PhD, codirector of the JDRF Center of Excellence at the University of Michigan, Ann Arbor, and president-elect for medicine and science of the American Diabetes Association. Dr. Busui is also lead author of an ADA/American College of Cardiology consensus report on heart failure in diabetes.
The study hypothesized that fluid retention “is a known but underappreciated side effect” of NSAID use and that short-term NSAID use could lead to heart failure in patients with type 2 diabetes, which has been linked to subclinical cardiomyopathy and kidney dysfunction.
“According to this study and particularly the subgroups analyses, it seems that incident heart failure associated with short-term NSAID use could be more than ‘just fluid overload,’ ” Dr. Holt said. “Further investigations into the specific mechanisms causing these associations are warranted.”
The study identified 331,189 patients with type 2 diabetes in nationwide Danish registries from 1998 to 2018. Median age was 62 years, and 23,308 (7%) were hospitalized with heart failure during follow-up, Dr. Holt said. Of them, 16% claimed at least one NSAID prescription within 2 years and 3% claimed they had at least three prescriptions.
Study follow-up started 120 days after the first-time type 2 diabetes diagnosis and focused on patients who had no previous diagnosis of heart failure or rheumatologic disease. The investigators reported on patients who had one, two, three or four prescriptions for NSAID within a year of starting follow-up.
The study used a case-crossover design, which, the abstract stated, “uses each individual as his or her own control making it suitable to study the effect of short-term exposure on immediate events while mitigating unmeasured confounding.”
Dr. Holt noted that short-term NSAID use was linked to increased risk of heart failure hospitalization (odds ratio, 1.43; 95% confidence interval, 1.27-1.63). The investigators identified even greater risks in three subgroups: age of at least 80 years (OR, 1.78; 95% CI, 1.39-2.28), elevated A1c levels treated with one or less antidiabetic medication (OR 1.68; 95% CI, 1-2.88), and patients without previous NSAID use (OR, 2.71; 95% CI, 1.78-4.23).
In the cohort, celecoxib and naproxen were rarely used (0.4 and 0.9%, respectively), while 3.3% of patients took diclofenac or 12.2% ibuprofen. The latter two NSAIDs had ORs of 1.48 and 1.46, respectively, for hospitalization for new-onset heart failure using 28-day exposure windows (95% CI for both, 1.1-2 and 1.26-1.69). No increased risk emerged for celecoxib or naproxen.
“High age and A1c levels and being a new user were tied to the strongest associations, along with known use of RASi [renin-angiotensin system inhibitors] and diuretics,” Dr. Holt said. “On the contrary, it seemed safe – from our data – to prescribe short-term NSAIDs for patients below 65 years of age and patients with normal A1c levels.
“Interestingly,” he added, “subclinical structural heart disease among patients with type 2 diabetes could play an important role.”
The findings are noteworthy, Dr. Busui said. “Although there are some limitations with the study design in general when one looks at data extracted from registers, the very large sample size and the fact that the Danish national register captures data in a standardized fashion does make the findings very relevant, especially now that we have confirmed that heart failure is the most prevalent cardiovascular complication in people with diabetes, as we have highlighted in the most recent ADA/ACC consensus on heart failure in diabetes.”
The study received funding from the Danish Heart Foundation and a number of private foundations. Dr. Holt and colleagues have no disclosures. Dr. Busui disclosed relationships with AstraZeneca, Boehringer Ingelheim–Lilly Alliance, Novo Nordisk, Averitas Pharma, Nevro, Regenacy Pharmaceuticals and Roche Diagnostics.
FROM ESC CONGRESS 2022
FDA clears new neurostimulation system for chronic pain
The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.
“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.
The system also has therapy settings accessed with a mobile device.
Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
Game changer?
The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.
More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.
Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.
“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.
“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.
A version of this article first appeared on Medscape.com.
The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.
“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.
The system also has therapy settings accessed with a mobile device.
Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
Game changer?
The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.
More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.
Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.
“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.
“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.
A version of this article first appeared on Medscape.com.
The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.
“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.
The system also has therapy settings accessed with a mobile device.
Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
Game changer?
The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.
More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.
Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.
“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.
“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.
A version of this article first appeared on Medscape.com.