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Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
PRECISE-DAPT Score Predicts GI Bleeding Risk Among Post-PCI Patients
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ACG 2024
‘No Hint of Benefit’ in Large Colchicine Trial
WASHINGTON —
The CLEAR SYNERGY (OASIS 9) study, called “the largest trial ever of colchicine in acute MI,” showed no hint of benefit in an adverse event curve for colchicine relative to placebo over 5 years, which suggests that the role of this drug after myocardial infarction (MI) “is uncertain,” Sanjit Jolly, MD, an interventional cardiologist at Hamilton Health Sciences and a professor of medicine at McMaster University in Hamilton, Ontario, Canada, reported at Transcatheter Cardiovascular Therapeutics (TCT) 2024.
For the primary composite outcome — cardiovascular death, MI, stroke, and ischemia-driven revascularization — the event curves in the colchicine and placebo groups remained essentially superimposed over 5 years of follow-up, with only a slight separation after 4 years. The hazard ratio for the primary endpoint showed a 1% difference in favor of colchicine (hazard ratio [HR], 0.99; P = .93).
There were no meaningful differences in any of the individual endpoint components; all 95% CIs straddled the line of unity. Rates of cardiovascular death (3.3% vs 3.2%) and stroke (1.4% vs 1.2%) were numerically higher in the colchicine group than in the placebo group. Rates of MI (2.9% vs 3.1%) and ischemia-driven revascularization (4.6% vs 4.7%) were numerically lower in the colchicine group.
No Difference
No adverse outcomes, including all-cause death (4.6% vs 5.1%), approached significance, with the exception of noncardiovascular death (13.0% vs 1.9%). For this outcome, the 95% CI stopped just short of the line of unity (HR, 0.68; 95% CI, 0.46-0.99).
Rates of adverse events (31.9% vs 31.7%; P = .86), serious adverse events (6.7% vs 7.4%; P = .22), and serious infections (2.5% vs 2.9%; P = .85) were similar in the colchicine and placebo groups, but diarrhea, a known side effect of colchicine, was higher in the colchicine group (10.2% vs 6.6%; P < .001).
Given these results, a panelist questioned the use of the word “uncertain” to describe the findings during the late-breaker session in which these results were presented.
“I think you are selling yourself short,” said J. Dawn Abbott, MD, director of the Interventional Cardiology Fellowship Training Program at the Lifespan Cardiovascular Institute, Brown University in Providence, Rhode Island. Based on the size and conduct of this trial, she called the results “definitive” and suggested that the guidelines should be adjusted.
The OASIS 9 Trial
In OASIS 9, 3528 patients were randomized to colchicine, and 3534 were randomized to placebo. A second randomization in both groups was to spironolactone or placebo; these results will be presented at the upcoming American Heart Association (AHA) 2024 meeting. Both analyses will be published in The New England Journal of Medicine at that time, Jolly reported.
The study involved 104 sites in Australia, Egypt, Europe, Nepal, and North America. Follow-up in both groups exceeded 99%. Most patients had an ST-elevation MI (STEMI), but about 5% of those enrolled had a non-STEMI. Less than 10% of patients had experienced a previous MI.
Less than 5% of patients were discharged on sodium-glucose cotransporter 2 therapy, and more than 95% were discharged on aspirin and a statin. Nearly 80% were discharged on an angiotensin-converting enzyme inhibitor, and most patients received an anticoagulant. More than 95% of patients were implanted with a drug-eluting stent.
At month 3, C-reactive protein levels were significantly lower in the colchicine group than in the placebo group. C-reactive protein is a biomarker for the anti-inflammatory effect that is considered to be colchicine’s primary mechanism of action. An anti-inflammatory effect has been cited as the probable explanation for the positive results shown in the COLCOT and LODOCO2 trials, published in 2019 and 2020, respectively.
In COLCOT, which randomized 4745 patients who experienced an acute MI in the previous 30 days, colchicine was associated with a 23% reduction in a composite major cardiovascular adverse events endpoint relative to placebo (HR, 0.77; P = .02). In LODOCO2, which randomized 5522 patients with chronic coronary disease, colchicine was associated with a 31% reduction in an adverse event composite endpoint (HR, 0.68; P < .0001).
However, two more recent trials — CONVINCE and CHANCE-3 — showed no difference between colchicine and placebo for the endpoint of recurrent stroke at 90 days. CONVINCE, with approximately 3000 patients, was relatively small, whereas CHANCE-3 randomized more than 8000 patients and showed no effect on the risk for stroke (HR, 0.98; 95% CI, 0.83-1.16).
New Data Challenge Guidelines
Of these trials, COLCOT was the most similar to OASIS 9, according to Jolly. Among the differences, OASIS 9 was initiated earlier and was larger than the other trials, so it had more power to address the study question.
Given the absence of benefit, Jolly indicated that OASIS 9 might disrupt both the joint American College of Cardiology and AHA guidelines, which gave colchicine a class 2b recommendation in 2023, and the European Society of Cardiology guidelines, which gave colchicine a 2a recommendation.
“This is a big deal for me,” said Ajay J. Kirtane, director of the Interventional Cardiovascular Care program at Columbia University in New York City. As someone who is now using colchicine routinely, these data have changed his opinion.
The previous data supporting the use of colchicine “were just so-so,” he explained. “Now I have a good rationale” for foregoing the routine use of this therapy.
Jolly said that he had put his own father on colchicine after an acute MI on the basis of the guidelines, but immediately took him off this therapy when the data from OASIS 9 were unblinded.
“The only signal from this trial was an increased risk of diarrhea,” Jolly said. The results, at the very least, suggest that colchicine “is not for everyone” after an acute MI, although he emphasized that these results do not rule out the potential for benefit from anti-inflammatory therapy. Ongoing trials, including one targeting interleukin 6, a cytokine associated with inflammation, remain of interest, he added.
A version of this article first appeared on Medscape.com.
WASHINGTON —
The CLEAR SYNERGY (OASIS 9) study, called “the largest trial ever of colchicine in acute MI,” showed no hint of benefit in an adverse event curve for colchicine relative to placebo over 5 years, which suggests that the role of this drug after myocardial infarction (MI) “is uncertain,” Sanjit Jolly, MD, an interventional cardiologist at Hamilton Health Sciences and a professor of medicine at McMaster University in Hamilton, Ontario, Canada, reported at Transcatheter Cardiovascular Therapeutics (TCT) 2024.
For the primary composite outcome — cardiovascular death, MI, stroke, and ischemia-driven revascularization — the event curves in the colchicine and placebo groups remained essentially superimposed over 5 years of follow-up, with only a slight separation after 4 years. The hazard ratio for the primary endpoint showed a 1% difference in favor of colchicine (hazard ratio [HR], 0.99; P = .93).
There were no meaningful differences in any of the individual endpoint components; all 95% CIs straddled the line of unity. Rates of cardiovascular death (3.3% vs 3.2%) and stroke (1.4% vs 1.2%) were numerically higher in the colchicine group than in the placebo group. Rates of MI (2.9% vs 3.1%) and ischemia-driven revascularization (4.6% vs 4.7%) were numerically lower in the colchicine group.
No Difference
No adverse outcomes, including all-cause death (4.6% vs 5.1%), approached significance, with the exception of noncardiovascular death (13.0% vs 1.9%). For this outcome, the 95% CI stopped just short of the line of unity (HR, 0.68; 95% CI, 0.46-0.99).
Rates of adverse events (31.9% vs 31.7%; P = .86), serious adverse events (6.7% vs 7.4%; P = .22), and serious infections (2.5% vs 2.9%; P = .85) were similar in the colchicine and placebo groups, but diarrhea, a known side effect of colchicine, was higher in the colchicine group (10.2% vs 6.6%; P < .001).
Given these results, a panelist questioned the use of the word “uncertain” to describe the findings during the late-breaker session in which these results were presented.
“I think you are selling yourself short,” said J. Dawn Abbott, MD, director of the Interventional Cardiology Fellowship Training Program at the Lifespan Cardiovascular Institute, Brown University in Providence, Rhode Island. Based on the size and conduct of this trial, she called the results “definitive” and suggested that the guidelines should be adjusted.
The OASIS 9 Trial
In OASIS 9, 3528 patients were randomized to colchicine, and 3534 were randomized to placebo. A second randomization in both groups was to spironolactone or placebo; these results will be presented at the upcoming American Heart Association (AHA) 2024 meeting. Both analyses will be published in The New England Journal of Medicine at that time, Jolly reported.
The study involved 104 sites in Australia, Egypt, Europe, Nepal, and North America. Follow-up in both groups exceeded 99%. Most patients had an ST-elevation MI (STEMI), but about 5% of those enrolled had a non-STEMI. Less than 10% of patients had experienced a previous MI.
Less than 5% of patients were discharged on sodium-glucose cotransporter 2 therapy, and more than 95% were discharged on aspirin and a statin. Nearly 80% were discharged on an angiotensin-converting enzyme inhibitor, and most patients received an anticoagulant. More than 95% of patients were implanted with a drug-eluting stent.
At month 3, C-reactive protein levels were significantly lower in the colchicine group than in the placebo group. C-reactive protein is a biomarker for the anti-inflammatory effect that is considered to be colchicine’s primary mechanism of action. An anti-inflammatory effect has been cited as the probable explanation for the positive results shown in the COLCOT and LODOCO2 trials, published in 2019 and 2020, respectively.
In COLCOT, which randomized 4745 patients who experienced an acute MI in the previous 30 days, colchicine was associated with a 23% reduction in a composite major cardiovascular adverse events endpoint relative to placebo (HR, 0.77; P = .02). In LODOCO2, which randomized 5522 patients with chronic coronary disease, colchicine was associated with a 31% reduction in an adverse event composite endpoint (HR, 0.68; P < .0001).
However, two more recent trials — CONVINCE and CHANCE-3 — showed no difference between colchicine and placebo for the endpoint of recurrent stroke at 90 days. CONVINCE, with approximately 3000 patients, was relatively small, whereas CHANCE-3 randomized more than 8000 patients and showed no effect on the risk for stroke (HR, 0.98; 95% CI, 0.83-1.16).
New Data Challenge Guidelines
Of these trials, COLCOT was the most similar to OASIS 9, according to Jolly. Among the differences, OASIS 9 was initiated earlier and was larger than the other trials, so it had more power to address the study question.
Given the absence of benefit, Jolly indicated that OASIS 9 might disrupt both the joint American College of Cardiology and AHA guidelines, which gave colchicine a class 2b recommendation in 2023, and the European Society of Cardiology guidelines, which gave colchicine a 2a recommendation.
“This is a big deal for me,” said Ajay J. Kirtane, director of the Interventional Cardiovascular Care program at Columbia University in New York City. As someone who is now using colchicine routinely, these data have changed his opinion.
The previous data supporting the use of colchicine “were just so-so,” he explained. “Now I have a good rationale” for foregoing the routine use of this therapy.
Jolly said that he had put his own father on colchicine after an acute MI on the basis of the guidelines, but immediately took him off this therapy when the data from OASIS 9 were unblinded.
“The only signal from this trial was an increased risk of diarrhea,” Jolly said. The results, at the very least, suggest that colchicine “is not for everyone” after an acute MI, although he emphasized that these results do not rule out the potential for benefit from anti-inflammatory therapy. Ongoing trials, including one targeting interleukin 6, a cytokine associated with inflammation, remain of interest, he added.
A version of this article first appeared on Medscape.com.
WASHINGTON —
The CLEAR SYNERGY (OASIS 9) study, called “the largest trial ever of colchicine in acute MI,” showed no hint of benefit in an adverse event curve for colchicine relative to placebo over 5 years, which suggests that the role of this drug after myocardial infarction (MI) “is uncertain,” Sanjit Jolly, MD, an interventional cardiologist at Hamilton Health Sciences and a professor of medicine at McMaster University in Hamilton, Ontario, Canada, reported at Transcatheter Cardiovascular Therapeutics (TCT) 2024.
For the primary composite outcome — cardiovascular death, MI, stroke, and ischemia-driven revascularization — the event curves in the colchicine and placebo groups remained essentially superimposed over 5 years of follow-up, with only a slight separation after 4 years. The hazard ratio for the primary endpoint showed a 1% difference in favor of colchicine (hazard ratio [HR], 0.99; P = .93).
There were no meaningful differences in any of the individual endpoint components; all 95% CIs straddled the line of unity. Rates of cardiovascular death (3.3% vs 3.2%) and stroke (1.4% vs 1.2%) were numerically higher in the colchicine group than in the placebo group. Rates of MI (2.9% vs 3.1%) and ischemia-driven revascularization (4.6% vs 4.7%) were numerically lower in the colchicine group.
No Difference
No adverse outcomes, including all-cause death (4.6% vs 5.1%), approached significance, with the exception of noncardiovascular death (13.0% vs 1.9%). For this outcome, the 95% CI stopped just short of the line of unity (HR, 0.68; 95% CI, 0.46-0.99).
Rates of adverse events (31.9% vs 31.7%; P = .86), serious adverse events (6.7% vs 7.4%; P = .22), and serious infections (2.5% vs 2.9%; P = .85) were similar in the colchicine and placebo groups, but diarrhea, a known side effect of colchicine, was higher in the colchicine group (10.2% vs 6.6%; P < .001).
Given these results, a panelist questioned the use of the word “uncertain” to describe the findings during the late-breaker session in which these results were presented.
“I think you are selling yourself short,” said J. Dawn Abbott, MD, director of the Interventional Cardiology Fellowship Training Program at the Lifespan Cardiovascular Institute, Brown University in Providence, Rhode Island. Based on the size and conduct of this trial, she called the results “definitive” and suggested that the guidelines should be adjusted.
The OASIS 9 Trial
In OASIS 9, 3528 patients were randomized to colchicine, and 3534 were randomized to placebo. A second randomization in both groups was to spironolactone or placebo; these results will be presented at the upcoming American Heart Association (AHA) 2024 meeting. Both analyses will be published in The New England Journal of Medicine at that time, Jolly reported.
The study involved 104 sites in Australia, Egypt, Europe, Nepal, and North America. Follow-up in both groups exceeded 99%. Most patients had an ST-elevation MI (STEMI), but about 5% of those enrolled had a non-STEMI. Less than 10% of patients had experienced a previous MI.
Less than 5% of patients were discharged on sodium-glucose cotransporter 2 therapy, and more than 95% were discharged on aspirin and a statin. Nearly 80% were discharged on an angiotensin-converting enzyme inhibitor, and most patients received an anticoagulant. More than 95% of patients were implanted with a drug-eluting stent.
At month 3, C-reactive protein levels were significantly lower in the colchicine group than in the placebo group. C-reactive protein is a biomarker for the anti-inflammatory effect that is considered to be colchicine’s primary mechanism of action. An anti-inflammatory effect has been cited as the probable explanation for the positive results shown in the COLCOT and LODOCO2 trials, published in 2019 and 2020, respectively.
In COLCOT, which randomized 4745 patients who experienced an acute MI in the previous 30 days, colchicine was associated with a 23% reduction in a composite major cardiovascular adverse events endpoint relative to placebo (HR, 0.77; P = .02). In LODOCO2, which randomized 5522 patients with chronic coronary disease, colchicine was associated with a 31% reduction in an adverse event composite endpoint (HR, 0.68; P < .0001).
However, two more recent trials — CONVINCE and CHANCE-3 — showed no difference between colchicine and placebo for the endpoint of recurrent stroke at 90 days. CONVINCE, with approximately 3000 patients, was relatively small, whereas CHANCE-3 randomized more than 8000 patients and showed no effect on the risk for stroke (HR, 0.98; 95% CI, 0.83-1.16).
New Data Challenge Guidelines
Of these trials, COLCOT was the most similar to OASIS 9, according to Jolly. Among the differences, OASIS 9 was initiated earlier and was larger than the other trials, so it had more power to address the study question.
Given the absence of benefit, Jolly indicated that OASIS 9 might disrupt both the joint American College of Cardiology and AHA guidelines, which gave colchicine a class 2b recommendation in 2023, and the European Society of Cardiology guidelines, which gave colchicine a 2a recommendation.
“This is a big deal for me,” said Ajay J. Kirtane, director of the Interventional Cardiovascular Care program at Columbia University in New York City. As someone who is now using colchicine routinely, these data have changed his opinion.
The previous data supporting the use of colchicine “were just so-so,” he explained. “Now I have a good rationale” for foregoing the routine use of this therapy.
Jolly said that he had put his own father on colchicine after an acute MI on the basis of the guidelines, but immediately took him off this therapy when the data from OASIS 9 were unblinded.
“The only signal from this trial was an increased risk of diarrhea,” Jolly said. The results, at the very least, suggest that colchicine “is not for everyone” after an acute MI, although he emphasized that these results do not rule out the potential for benefit from anti-inflammatory therapy. Ongoing trials, including one targeting interleukin 6, a cytokine associated with inflammation, remain of interest, he added.
A version of this article first appeared on Medscape.com.
FROM TCT 2024
Retire? Not Me! A Physician’s Journey of Reinvention
I’ve tried to retire from medicine. Really. Proofs of my sincerity include a true retirement from performing procedures and the closing of two office practices. I even attended the wonderful retirement party my daughters threw for me.
I had great plans for my newfound leisure time. I purchased about a thousand colored pencils to map my family ancestry. I wore out many magic erasers in my cleaning efforts. I cajoled my husband, Tony, to help me build not one, but three, gardens in our yard. Upon realizing I had no more weeds or closets to conquer, I began a Dante-like descent into a dark abyss. I felt my sadness was justified. After all, I had immensely enjoyed my early medical life.
From Private Practice to Being Employed
I had a joint cardiology practice with the great Jim Whiteside, MD, in South Central Kentucky for 24 years. Our schedule was always bursting at the seams in the heart of tobacco country. We opened the first cath lab in our hospital, inspired the purchase of a new nuclear scanner, and expanded the stress echo lab. After a 6-year odyssey, we successfully championed primary PCI without surgery on site (along with Ephraim McDowell Regional Medical Center in Danville, Kentucky). As our services expanded, we remodeled to accommodate three cardiologists and two nurse practitioners. Simultaneously, we lobbied our city council and mayor to pass smoke-free legislation, a lightning rod topic in a culture still loyal to a burning weed whose worth had paled in comparison to the cost of its carnage. We were “running wide open” and believed that we were doing important work.
But then our forward-thinking, appreciative CEO and friend died suddenly, and the open communication and innovation seemingly vanished. Those events inspired my first “retirement.” After this, I became employed for the first time and was blessed once again with a wonderful partner and colleagues. But despite those blessings, the global practice of medicine had begun to change. Physicians were now seen by some as widgets; their worth measured in productivity. A few years in, I needed part-time work to care for my aging parents. My employer needed more, thus inspiring my second “retirement”.
My Second ‘Retirement’
My parents died within 4 months of each other in 2020. Suddenly, I was untethered from both my professional persona and role as caregiver. It was then that my sadness accelerated toward what seemed like the second circle of Hell, with many more to come.
To many, my sadness made no sense. Our accountant reassured us that we no longer “needed” to work, and I was (and still am) happily married to my high school sweetheart. Our beautiful daughters were healthy and thriving. Although I mouthed appreciation for my blessings in prayer, I could not prevent myself from sinking further.
My always supportive husband was worried. Tony had skipped happily into his retirement from teaching. He had hoped I would do that same. “You cannot sit on that couch and mope for the rest of your life,” he said, exasperated.
I thought about doing just that, until one day I answered a phone call to hear, “Doctor, have you ever been to Montana?” Before I could cut her off, the woman charged into the description of a job opening for a locums cardiologist. I immediately sat up. “No office work?” I questioned.
“No, this is strictly hospital call, rounds, and reading studies.” I didn’t know such jobs existed.
“What is the salary, and what do you cover?” I asked trying to conceal the fact that Tony would have gladly paid her to get me off the couch.
Finding What Suits Me
If I’m honest, since my training days, hospital work is all I have ever wanted. I’ve always felt trapped by the imaginary timer that is part of every office visit. I found running a code less challenging than having to stand and end an office visit that might leave a patient wanting more.
On hospital days, there are no scheduled time slots. I can triage patients according to their needs. My deadlines are self-imposed: To have a morning coffee with Tony. To deliver the best care possible. To educate as much as time will allow. To beat the midnight clock, after which billing is a little more difficult.
I will soon begin my seventh year as an inpatient, acute-care cardiologist. Although I was flattered to be considered for full-time work, I couldn’t do that to Tony (who declined to move from Kentucky). We struck a deal that we’d travel to the same facility, where I work seven to nine jobs a year.
Tony golfs while I work and he jokes that he is a “real go-getter,” explaining that “I take her to work in the morning and then at night, I go get her!”
For those considering this line of work, it’s not for the faint of heart. My workday can stretch to over 16 hours. But I work in the best of hospital settings. On morning rounds, we present every single patient on the service. Our ER is staffed 100% of the time with at least four board-certified emergency medicine trained physicians. Everyone I work with shares a patient-first philosophy.
Because of this, I have quite easily ascended from Dante’s inferno. I am happy again in my professional life.
I know I’ll eventually have to retire for real, and I hope it will be at a time of my choosing and not enforced by the failings of modern medicine. I believe that these past few years will help ease that transition. And when that time comes, I’ll able to look back and know that I was blessed with a long and mostly satisfying career.
Until then, my magic erasers, colored pencils and gardening will have to wait.
Dr. Walton-Shirley is a clinical cardiologist from Nashville, Tennessee. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
I’ve tried to retire from medicine. Really. Proofs of my sincerity include a true retirement from performing procedures and the closing of two office practices. I even attended the wonderful retirement party my daughters threw for me.
I had great plans for my newfound leisure time. I purchased about a thousand colored pencils to map my family ancestry. I wore out many magic erasers in my cleaning efforts. I cajoled my husband, Tony, to help me build not one, but three, gardens in our yard. Upon realizing I had no more weeds or closets to conquer, I began a Dante-like descent into a dark abyss. I felt my sadness was justified. After all, I had immensely enjoyed my early medical life.
From Private Practice to Being Employed
I had a joint cardiology practice with the great Jim Whiteside, MD, in South Central Kentucky for 24 years. Our schedule was always bursting at the seams in the heart of tobacco country. We opened the first cath lab in our hospital, inspired the purchase of a new nuclear scanner, and expanded the stress echo lab. After a 6-year odyssey, we successfully championed primary PCI without surgery on site (along with Ephraim McDowell Regional Medical Center in Danville, Kentucky). As our services expanded, we remodeled to accommodate three cardiologists and two nurse practitioners. Simultaneously, we lobbied our city council and mayor to pass smoke-free legislation, a lightning rod topic in a culture still loyal to a burning weed whose worth had paled in comparison to the cost of its carnage. We were “running wide open” and believed that we were doing important work.
But then our forward-thinking, appreciative CEO and friend died suddenly, and the open communication and innovation seemingly vanished. Those events inspired my first “retirement.” After this, I became employed for the first time and was blessed once again with a wonderful partner and colleagues. But despite those blessings, the global practice of medicine had begun to change. Physicians were now seen by some as widgets; their worth measured in productivity. A few years in, I needed part-time work to care for my aging parents. My employer needed more, thus inspiring my second “retirement”.
My Second ‘Retirement’
My parents died within 4 months of each other in 2020. Suddenly, I was untethered from both my professional persona and role as caregiver. It was then that my sadness accelerated toward what seemed like the second circle of Hell, with many more to come.
To many, my sadness made no sense. Our accountant reassured us that we no longer “needed” to work, and I was (and still am) happily married to my high school sweetheart. Our beautiful daughters were healthy and thriving. Although I mouthed appreciation for my blessings in prayer, I could not prevent myself from sinking further.
My always supportive husband was worried. Tony had skipped happily into his retirement from teaching. He had hoped I would do that same. “You cannot sit on that couch and mope for the rest of your life,” he said, exasperated.
I thought about doing just that, until one day I answered a phone call to hear, “Doctor, have you ever been to Montana?” Before I could cut her off, the woman charged into the description of a job opening for a locums cardiologist. I immediately sat up. “No office work?” I questioned.
“No, this is strictly hospital call, rounds, and reading studies.” I didn’t know such jobs existed.
“What is the salary, and what do you cover?” I asked trying to conceal the fact that Tony would have gladly paid her to get me off the couch.
Finding What Suits Me
If I’m honest, since my training days, hospital work is all I have ever wanted. I’ve always felt trapped by the imaginary timer that is part of every office visit. I found running a code less challenging than having to stand and end an office visit that might leave a patient wanting more.
On hospital days, there are no scheduled time slots. I can triage patients according to their needs. My deadlines are self-imposed: To have a morning coffee with Tony. To deliver the best care possible. To educate as much as time will allow. To beat the midnight clock, after which billing is a little more difficult.
I will soon begin my seventh year as an inpatient, acute-care cardiologist. Although I was flattered to be considered for full-time work, I couldn’t do that to Tony (who declined to move from Kentucky). We struck a deal that we’d travel to the same facility, where I work seven to nine jobs a year.
Tony golfs while I work and he jokes that he is a “real go-getter,” explaining that “I take her to work in the morning and then at night, I go get her!”
For those considering this line of work, it’s not for the faint of heart. My workday can stretch to over 16 hours. But I work in the best of hospital settings. On morning rounds, we present every single patient on the service. Our ER is staffed 100% of the time with at least four board-certified emergency medicine trained physicians. Everyone I work with shares a patient-first philosophy.
Because of this, I have quite easily ascended from Dante’s inferno. I am happy again in my professional life.
I know I’ll eventually have to retire for real, and I hope it will be at a time of my choosing and not enforced by the failings of modern medicine. I believe that these past few years will help ease that transition. And when that time comes, I’ll able to look back and know that I was blessed with a long and mostly satisfying career.
Until then, my magic erasers, colored pencils and gardening will have to wait.
Dr. Walton-Shirley is a clinical cardiologist from Nashville, Tennessee. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
I’ve tried to retire from medicine. Really. Proofs of my sincerity include a true retirement from performing procedures and the closing of two office practices. I even attended the wonderful retirement party my daughters threw for me.
I had great plans for my newfound leisure time. I purchased about a thousand colored pencils to map my family ancestry. I wore out many magic erasers in my cleaning efforts. I cajoled my husband, Tony, to help me build not one, but three, gardens in our yard. Upon realizing I had no more weeds or closets to conquer, I began a Dante-like descent into a dark abyss. I felt my sadness was justified. After all, I had immensely enjoyed my early medical life.
From Private Practice to Being Employed
I had a joint cardiology practice with the great Jim Whiteside, MD, in South Central Kentucky for 24 years. Our schedule was always bursting at the seams in the heart of tobacco country. We opened the first cath lab in our hospital, inspired the purchase of a new nuclear scanner, and expanded the stress echo lab. After a 6-year odyssey, we successfully championed primary PCI without surgery on site (along with Ephraim McDowell Regional Medical Center in Danville, Kentucky). As our services expanded, we remodeled to accommodate three cardiologists and two nurse practitioners. Simultaneously, we lobbied our city council and mayor to pass smoke-free legislation, a lightning rod topic in a culture still loyal to a burning weed whose worth had paled in comparison to the cost of its carnage. We were “running wide open” and believed that we were doing important work.
But then our forward-thinking, appreciative CEO and friend died suddenly, and the open communication and innovation seemingly vanished. Those events inspired my first “retirement.” After this, I became employed for the first time and was blessed once again with a wonderful partner and colleagues. But despite those blessings, the global practice of medicine had begun to change. Physicians were now seen by some as widgets; their worth measured in productivity. A few years in, I needed part-time work to care for my aging parents. My employer needed more, thus inspiring my second “retirement”.
My Second ‘Retirement’
My parents died within 4 months of each other in 2020. Suddenly, I was untethered from both my professional persona and role as caregiver. It was then that my sadness accelerated toward what seemed like the second circle of Hell, with many more to come.
To many, my sadness made no sense. Our accountant reassured us that we no longer “needed” to work, and I was (and still am) happily married to my high school sweetheart. Our beautiful daughters were healthy and thriving. Although I mouthed appreciation for my blessings in prayer, I could not prevent myself from sinking further.
My always supportive husband was worried. Tony had skipped happily into his retirement from teaching. He had hoped I would do that same. “You cannot sit on that couch and mope for the rest of your life,” he said, exasperated.
I thought about doing just that, until one day I answered a phone call to hear, “Doctor, have you ever been to Montana?” Before I could cut her off, the woman charged into the description of a job opening for a locums cardiologist. I immediately sat up. “No office work?” I questioned.
“No, this is strictly hospital call, rounds, and reading studies.” I didn’t know such jobs existed.
“What is the salary, and what do you cover?” I asked trying to conceal the fact that Tony would have gladly paid her to get me off the couch.
Finding What Suits Me
If I’m honest, since my training days, hospital work is all I have ever wanted. I’ve always felt trapped by the imaginary timer that is part of every office visit. I found running a code less challenging than having to stand and end an office visit that might leave a patient wanting more.
On hospital days, there are no scheduled time slots. I can triage patients according to their needs. My deadlines are self-imposed: To have a morning coffee with Tony. To deliver the best care possible. To educate as much as time will allow. To beat the midnight clock, after which billing is a little more difficult.
I will soon begin my seventh year as an inpatient, acute-care cardiologist. Although I was flattered to be considered for full-time work, I couldn’t do that to Tony (who declined to move from Kentucky). We struck a deal that we’d travel to the same facility, where I work seven to nine jobs a year.
Tony golfs while I work and he jokes that he is a “real go-getter,” explaining that “I take her to work in the morning and then at night, I go get her!”
For those considering this line of work, it’s not for the faint of heart. My workday can stretch to over 16 hours. But I work in the best of hospital settings. On morning rounds, we present every single patient on the service. Our ER is staffed 100% of the time with at least four board-certified emergency medicine trained physicians. Everyone I work with shares a patient-first philosophy.
Because of this, I have quite easily ascended from Dante’s inferno. I am happy again in my professional life.
I know I’ll eventually have to retire for real, and I hope it will be at a time of my choosing and not enforced by the failings of modern medicine. I believe that these past few years will help ease that transition. And when that time comes, I’ll able to look back and know that I was blessed with a long and mostly satisfying career.
Until then, my magic erasers, colored pencils and gardening will have to wait.
Dr. Walton-Shirley is a clinical cardiologist from Nashville, Tennessee. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Goodbye CHADSVASc: Sex Complicates Stroke Risk Scoring in AF
The European Society of Cardiology (ESC) caused a stir when they recommended in their latest atrial fibrillation (AF) management guideline that gender no longer be included in the decision to initiate oral anticoagulation therapy.
The move aims to level the playing field between men and women and follows a more nuanced understanding of stroke risk in patients with AF, said experts. It also acknowledges the lack of evidence in people receiving cross-sex hormone therapy.
In any case, the guidelines, developed in collaboration with the European Association for Cardio-Thoracic Surgery and published by the European Heart Journal on August 30, simply follow 2023’s US recommendations, they added.
One Size Does Not Fit All
So, what to the ESC guidelines actually say?
They underline that, if left untreated, the risk for ischemic stroke is increased fivefold in patients with AF, and the “default approach should therefore be to provide oral anticoagulation to all eligible AF patients, except those at low risk for incident stroke or thromboembolism.”
However, the authors note that there is a lack of strong evidence on how to apply the current risk scores to help inform that decision in real-world patients.
Dipak Kotecha, MBChB, PhD, Professor of Cardiology at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, and senior author of the ESC guidelines, said in an interview that “the available scores have a relatively poor ability to accurately predict which patients will have a stroke or thromboembolic event.”
Instead, he said “a much better approach is for healthcare professionals to look at each patient’s individual risk factors, using the risk scores to identify those patients that might not benefit from oral anticoagulant therapy.”
For these guidelines, the authors therefore wanted to “move away from a one-size-fits-all” approach, Kotecha said, and instead ensure that more patients can benefit from the new range of direct oral anticoagulants (DOACs) that are easier to take and with much lower chance of side effects or major bleeding.
To achieve this, they separated their clinical recommendations from any particular risk score, and instead focused on the practicalities of implementation.
Risk Modifier Vs Risk Factor
To explain their decision the authors highlight that “the most popular risk score” is the CHA2DS2–VASc, which gives a point for female sex, alongside factors such as congestive heart failure, hypertension, and diabetes mellitus, and a sliding scale of points for increasing age.
Kotecha pointed out the score was developed before the DOACs were available and may not account for how risk factors have changed in recent decades.
The result is that CHA2DS2–VASc gives the same number of points to an individual with heart failure or prior transient ischemic attack as to a woman aged less than 65 years, “but the magnitude of increased risk is not the same,” Usha Beth Tedrow, MD, Associate Professor of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, said in an interview.
As far back as 2018, it was known that “female sex is a risk modifier, rather than a risk factor for stroke in atrial fibrillation,” noted Jose Joglar, MD, lead author of the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation said in an interview.
A Danish national registry study involving 239,671 AF patients treated between 1997 and 2015, nearly half of whom were women, showed that, at a CHA2DS2–VASc score of 0, the “risk of stroke between men and women is absolutely the same,” he said.
“It is not until after a CHA2DS2–VASc score of 2 that the curves start to separate,” Joglar, Program Director, Clinical Cardiac Electrophysiology Fellowship Program, The University of Texas Southwestern Medical Center, Dallas, continued, “but by then you have already made the decision to anticoagulate.”
More recently, Kotecha and colleagues conducted a population cohort study of the electronic healthcare records of UK primary care patients treated between 2005 and 2020, and identified 78,852 with AF; more than a third were women.
Their analysis, published on September 1, showed that women had a lower adjusted rate of the primary composite outcome of all-cause mortality, ischemic stroke, or arterial thromboembolism, driven by a reduced mortality rate.
“Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation,” Kotecha and colleagues concluded.
Joglar clarified that “women are at increased risk for stroke than men” overall, but by the time that risk “becomes manifest, other risk factors have come into play, and they have already met the criteria for anticoagulation.”
The authors of the latest ESC guideline therefore concluded that the “inclusion of gender complicates clinical practice both for healthcare professionals and patients.” Their solution was to remove the question of gender for decisions over initiating oral anticoagulant therapy in clinical practice altogether.
This includes individuals who identify as transgender or are undergoing sex hormone therapy, as all the experts interviewed by Medscape Medical News agreed that there is currently insufficient evidence to know if that affects stroke risk.
Instead, guidelines state that the drugs are “recommended in those with a CHA2DS2-VA score of 2 or more and should be considered in those with a CHA2DS2-VA score of 1, following a patient-centered and shared care approach.”
“Dropping the gender part of the risk score is not really a substantial change” from previous ESC or other guidelines, as different points were required in the past to recommend anticoagulants for women and men, Kotecha said, adding that “making the approach easier for clinicians may avoid penalizing women as well as nonbinary and transgender patients.”
Anne B. Curtis, MD, SUNY Distinguished Professor, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo in New York, agreed.
Putting aside the question of female sex, she said that there are not a lot of people under the age of 65 years with “absolutely no risk factors,” and so, “if the only reason you would anticoagulate” someone of that age is because they are a woman that “doesn’t make a lot of sense to me.”
The ESC guidelines are “trying to say, ‘look at the other risk factors, and if anything is there, go ahead and anticoagulate,” Curtis said in an interview.
“It’s actually a very thoughtful decision,” Tedrow said, and not “intended to discount risk in women.” Rather, it’s a statement that acknowledges the problem of recommending anticoagulation therapy in women “for whom it is not appropriate.”
Joglar pointed out that that recommendation, although not characterized in the same way, was in fact included in the 2023 US guidelines.
“We wanted to use a more nuanced approach,” he said, and move away from using CHA2DS2–VASc as the prime determinant of whether to start oral anticoagulation and towards a magnitude risk assessment, in which female sex is seen as a risk modifier.
“The Europeans and the Americans are looking at the same data, so we often reach the same conclusions,” Joglar said, although “we sometimes use different wordings.”
Overall, Kotecha expressed the hope that the move “will lead to better implementation of guidelines, at the end of the day.”
“That’s all we can hope for: Patients will be offered a more individualized approach, leading to more appropriate use of treatment in the right patients.”
The newer direct oral anticoagulation is “a much simpler therapy,” he added. “There is very little monitoring, a similar risk of bleeding as aspirin, and yet the ability to largely prevent the high rate of stroke and thromboembolism associated with atrial fibrillation.”
“So, it’s a big ticket item for our communities and public health, particularly as atrial fibrillation is expected to double in prevalence in the next few decades and evidence is building that it can lead to vascular dementia in the long-term.”
No funding was declared. Kotecha declares relationships with Bayer, Protherics Medicines Development, Boston Scientific, Daiichi Sankyo, Boehringer Ingelheim, BMS-Pfizer Alliance, Amomed, MyoKardia. Curtis declared relationships with Janssen Pharmaceuticals, Medtronic, Abbott. Joglar declared no relevant relationships. Tedrow declared no relevant relationships.
A version of this article appeared on Medscape.com.
The European Society of Cardiology (ESC) caused a stir when they recommended in their latest atrial fibrillation (AF) management guideline that gender no longer be included in the decision to initiate oral anticoagulation therapy.
The move aims to level the playing field between men and women and follows a more nuanced understanding of stroke risk in patients with AF, said experts. It also acknowledges the lack of evidence in people receiving cross-sex hormone therapy.
In any case, the guidelines, developed in collaboration with the European Association for Cardio-Thoracic Surgery and published by the European Heart Journal on August 30, simply follow 2023’s US recommendations, they added.
One Size Does Not Fit All
So, what to the ESC guidelines actually say?
They underline that, if left untreated, the risk for ischemic stroke is increased fivefold in patients with AF, and the “default approach should therefore be to provide oral anticoagulation to all eligible AF patients, except those at low risk for incident stroke or thromboembolism.”
However, the authors note that there is a lack of strong evidence on how to apply the current risk scores to help inform that decision in real-world patients.
Dipak Kotecha, MBChB, PhD, Professor of Cardiology at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, and senior author of the ESC guidelines, said in an interview that “the available scores have a relatively poor ability to accurately predict which patients will have a stroke or thromboembolic event.”
Instead, he said “a much better approach is for healthcare professionals to look at each patient’s individual risk factors, using the risk scores to identify those patients that might not benefit from oral anticoagulant therapy.”
For these guidelines, the authors therefore wanted to “move away from a one-size-fits-all” approach, Kotecha said, and instead ensure that more patients can benefit from the new range of direct oral anticoagulants (DOACs) that are easier to take and with much lower chance of side effects or major bleeding.
To achieve this, they separated their clinical recommendations from any particular risk score, and instead focused on the practicalities of implementation.
Risk Modifier Vs Risk Factor
To explain their decision the authors highlight that “the most popular risk score” is the CHA2DS2–VASc, which gives a point for female sex, alongside factors such as congestive heart failure, hypertension, and diabetes mellitus, and a sliding scale of points for increasing age.
Kotecha pointed out the score was developed before the DOACs were available and may not account for how risk factors have changed in recent decades.
The result is that CHA2DS2–VASc gives the same number of points to an individual with heart failure or prior transient ischemic attack as to a woman aged less than 65 years, “but the magnitude of increased risk is not the same,” Usha Beth Tedrow, MD, Associate Professor of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, said in an interview.
As far back as 2018, it was known that “female sex is a risk modifier, rather than a risk factor for stroke in atrial fibrillation,” noted Jose Joglar, MD, lead author of the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation said in an interview.
A Danish national registry study involving 239,671 AF patients treated between 1997 and 2015, nearly half of whom were women, showed that, at a CHA2DS2–VASc score of 0, the “risk of stroke between men and women is absolutely the same,” he said.
“It is not until after a CHA2DS2–VASc score of 2 that the curves start to separate,” Joglar, Program Director, Clinical Cardiac Electrophysiology Fellowship Program, The University of Texas Southwestern Medical Center, Dallas, continued, “but by then you have already made the decision to anticoagulate.”
More recently, Kotecha and colleagues conducted a population cohort study of the electronic healthcare records of UK primary care patients treated between 2005 and 2020, and identified 78,852 with AF; more than a third were women.
Their analysis, published on September 1, showed that women had a lower adjusted rate of the primary composite outcome of all-cause mortality, ischemic stroke, or arterial thromboembolism, driven by a reduced mortality rate.
“Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation,” Kotecha and colleagues concluded.
Joglar clarified that “women are at increased risk for stroke than men” overall, but by the time that risk “becomes manifest, other risk factors have come into play, and they have already met the criteria for anticoagulation.”
The authors of the latest ESC guideline therefore concluded that the “inclusion of gender complicates clinical practice both for healthcare professionals and patients.” Their solution was to remove the question of gender for decisions over initiating oral anticoagulant therapy in clinical practice altogether.
This includes individuals who identify as transgender or are undergoing sex hormone therapy, as all the experts interviewed by Medscape Medical News agreed that there is currently insufficient evidence to know if that affects stroke risk.
Instead, guidelines state that the drugs are “recommended in those with a CHA2DS2-VA score of 2 or more and should be considered in those with a CHA2DS2-VA score of 1, following a patient-centered and shared care approach.”
“Dropping the gender part of the risk score is not really a substantial change” from previous ESC or other guidelines, as different points were required in the past to recommend anticoagulants for women and men, Kotecha said, adding that “making the approach easier for clinicians may avoid penalizing women as well as nonbinary and transgender patients.”
Anne B. Curtis, MD, SUNY Distinguished Professor, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo in New York, agreed.
Putting aside the question of female sex, she said that there are not a lot of people under the age of 65 years with “absolutely no risk factors,” and so, “if the only reason you would anticoagulate” someone of that age is because they are a woman that “doesn’t make a lot of sense to me.”
The ESC guidelines are “trying to say, ‘look at the other risk factors, and if anything is there, go ahead and anticoagulate,” Curtis said in an interview.
“It’s actually a very thoughtful decision,” Tedrow said, and not “intended to discount risk in women.” Rather, it’s a statement that acknowledges the problem of recommending anticoagulation therapy in women “for whom it is not appropriate.”
Joglar pointed out that that recommendation, although not characterized in the same way, was in fact included in the 2023 US guidelines.
“We wanted to use a more nuanced approach,” he said, and move away from using CHA2DS2–VASc as the prime determinant of whether to start oral anticoagulation and towards a magnitude risk assessment, in which female sex is seen as a risk modifier.
“The Europeans and the Americans are looking at the same data, so we often reach the same conclusions,” Joglar said, although “we sometimes use different wordings.”
Overall, Kotecha expressed the hope that the move “will lead to better implementation of guidelines, at the end of the day.”
“That’s all we can hope for: Patients will be offered a more individualized approach, leading to more appropriate use of treatment in the right patients.”
The newer direct oral anticoagulation is “a much simpler therapy,” he added. “There is very little monitoring, a similar risk of bleeding as aspirin, and yet the ability to largely prevent the high rate of stroke and thromboembolism associated with atrial fibrillation.”
“So, it’s a big ticket item for our communities and public health, particularly as atrial fibrillation is expected to double in prevalence in the next few decades and evidence is building that it can lead to vascular dementia in the long-term.”
No funding was declared. Kotecha declares relationships with Bayer, Protherics Medicines Development, Boston Scientific, Daiichi Sankyo, Boehringer Ingelheim, BMS-Pfizer Alliance, Amomed, MyoKardia. Curtis declared relationships with Janssen Pharmaceuticals, Medtronic, Abbott. Joglar declared no relevant relationships. Tedrow declared no relevant relationships.
A version of this article appeared on Medscape.com.
The European Society of Cardiology (ESC) caused a stir when they recommended in their latest atrial fibrillation (AF) management guideline that gender no longer be included in the decision to initiate oral anticoagulation therapy.
The move aims to level the playing field between men and women and follows a more nuanced understanding of stroke risk in patients with AF, said experts. It also acknowledges the lack of evidence in people receiving cross-sex hormone therapy.
In any case, the guidelines, developed in collaboration with the European Association for Cardio-Thoracic Surgery and published by the European Heart Journal on August 30, simply follow 2023’s US recommendations, they added.
One Size Does Not Fit All
So, what to the ESC guidelines actually say?
They underline that, if left untreated, the risk for ischemic stroke is increased fivefold in patients with AF, and the “default approach should therefore be to provide oral anticoagulation to all eligible AF patients, except those at low risk for incident stroke or thromboembolism.”
However, the authors note that there is a lack of strong evidence on how to apply the current risk scores to help inform that decision in real-world patients.
Dipak Kotecha, MBChB, PhD, Professor of Cardiology at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, and senior author of the ESC guidelines, said in an interview that “the available scores have a relatively poor ability to accurately predict which patients will have a stroke or thromboembolic event.”
Instead, he said “a much better approach is for healthcare professionals to look at each patient’s individual risk factors, using the risk scores to identify those patients that might not benefit from oral anticoagulant therapy.”
For these guidelines, the authors therefore wanted to “move away from a one-size-fits-all” approach, Kotecha said, and instead ensure that more patients can benefit from the new range of direct oral anticoagulants (DOACs) that are easier to take and with much lower chance of side effects or major bleeding.
To achieve this, they separated their clinical recommendations from any particular risk score, and instead focused on the practicalities of implementation.
Risk Modifier Vs Risk Factor
To explain their decision the authors highlight that “the most popular risk score” is the CHA2DS2–VASc, which gives a point for female sex, alongside factors such as congestive heart failure, hypertension, and diabetes mellitus, and a sliding scale of points for increasing age.
Kotecha pointed out the score was developed before the DOACs were available and may not account for how risk factors have changed in recent decades.
The result is that CHA2DS2–VASc gives the same number of points to an individual with heart failure or prior transient ischemic attack as to a woman aged less than 65 years, “but the magnitude of increased risk is not the same,” Usha Beth Tedrow, MD, Associate Professor of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, said in an interview.
As far back as 2018, it was known that “female sex is a risk modifier, rather than a risk factor for stroke in atrial fibrillation,” noted Jose Joglar, MD, lead author of the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation said in an interview.
A Danish national registry study involving 239,671 AF patients treated between 1997 and 2015, nearly half of whom were women, showed that, at a CHA2DS2–VASc score of 0, the “risk of stroke between men and women is absolutely the same,” he said.
“It is not until after a CHA2DS2–VASc score of 2 that the curves start to separate,” Joglar, Program Director, Clinical Cardiac Electrophysiology Fellowship Program, The University of Texas Southwestern Medical Center, Dallas, continued, “but by then you have already made the decision to anticoagulate.”
More recently, Kotecha and colleagues conducted a population cohort study of the electronic healthcare records of UK primary care patients treated between 2005 and 2020, and identified 78,852 with AF; more than a third were women.
Their analysis, published on September 1, showed that women had a lower adjusted rate of the primary composite outcome of all-cause mortality, ischemic stroke, or arterial thromboembolism, driven by a reduced mortality rate.
“Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation,” Kotecha and colleagues concluded.
Joglar clarified that “women are at increased risk for stroke than men” overall, but by the time that risk “becomes manifest, other risk factors have come into play, and they have already met the criteria for anticoagulation.”
The authors of the latest ESC guideline therefore concluded that the “inclusion of gender complicates clinical practice both for healthcare professionals and patients.” Their solution was to remove the question of gender for decisions over initiating oral anticoagulant therapy in clinical practice altogether.
This includes individuals who identify as transgender or are undergoing sex hormone therapy, as all the experts interviewed by Medscape Medical News agreed that there is currently insufficient evidence to know if that affects stroke risk.
Instead, guidelines state that the drugs are “recommended in those with a CHA2DS2-VA score of 2 or more and should be considered in those with a CHA2DS2-VA score of 1, following a patient-centered and shared care approach.”
“Dropping the gender part of the risk score is not really a substantial change” from previous ESC or other guidelines, as different points were required in the past to recommend anticoagulants for women and men, Kotecha said, adding that “making the approach easier for clinicians may avoid penalizing women as well as nonbinary and transgender patients.”
Anne B. Curtis, MD, SUNY Distinguished Professor, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo in New York, agreed.
Putting aside the question of female sex, she said that there are not a lot of people under the age of 65 years with “absolutely no risk factors,” and so, “if the only reason you would anticoagulate” someone of that age is because they are a woman that “doesn’t make a lot of sense to me.”
The ESC guidelines are “trying to say, ‘look at the other risk factors, and if anything is there, go ahead and anticoagulate,” Curtis said in an interview.
“It’s actually a very thoughtful decision,” Tedrow said, and not “intended to discount risk in women.” Rather, it’s a statement that acknowledges the problem of recommending anticoagulation therapy in women “for whom it is not appropriate.”
Joglar pointed out that that recommendation, although not characterized in the same way, was in fact included in the 2023 US guidelines.
“We wanted to use a more nuanced approach,” he said, and move away from using CHA2DS2–VASc as the prime determinant of whether to start oral anticoagulation and towards a magnitude risk assessment, in which female sex is seen as a risk modifier.
“The Europeans and the Americans are looking at the same data, so we often reach the same conclusions,” Joglar said, although “we sometimes use different wordings.”
Overall, Kotecha expressed the hope that the move “will lead to better implementation of guidelines, at the end of the day.”
“That’s all we can hope for: Patients will be offered a more individualized approach, leading to more appropriate use of treatment in the right patients.”
The newer direct oral anticoagulation is “a much simpler therapy,” he added. “There is very little monitoring, a similar risk of bleeding as aspirin, and yet the ability to largely prevent the high rate of stroke and thromboembolism associated with atrial fibrillation.”
“So, it’s a big ticket item for our communities and public health, particularly as atrial fibrillation is expected to double in prevalence in the next few decades and evidence is building that it can lead to vascular dementia in the long-term.”
No funding was declared. Kotecha declares relationships with Bayer, Protherics Medicines Development, Boston Scientific, Daiichi Sankyo, Boehringer Ingelheim, BMS-Pfizer Alliance, Amomed, MyoKardia. Curtis declared relationships with Janssen Pharmaceuticals, Medtronic, Abbott. Joglar declared no relevant relationships. Tedrow declared no relevant relationships.
A version of this article appeared on Medscape.com.
SCD: Can Atrial Arrhythmias Predict Strokes?
TOPLINE:
METHODOLOGY:
- A total of 130 adult patients with SCD were included in the DREPACOEUR prospective registry from November 2018 to November 2022.
- The patients underwent a comprehensive cardiac evaluation, including 24-hour electrocardiogram monitoring, echocardiography, and laboratory tests.
- The primary endpoint was the occurrence of atrial arrhythmias, defined by excessive supraventricular ectopic activity or any recent history of atrial fibrillation.
- Patients with a history of stroke or transient ischemic attack were also included in the PCDREP prospective registry for further assessment.
- Written informed consent was collected from all participating patients, and the study was approved by the ethics committee.
TAKEAWAY:
- Atrial arrhythmias were found in 26% of patients with SCD, with a significant association with stroke history (P = .001).
- Age and left atrial volume were independently associated with atrial arrhythmias, with optimal cutoffs of 47 years and 55 mL/m2, respectively.
- Patients with atrial arrhythmias had higher diastolic blood pressure, worse kidney function, and higher NT pro-BNP levels than those without arrhythmias.
- Atrial arrhythmias were associated with an increased risk for stroke unrelated to cerebral vasculopathy or other defined causes (odds ratio, 6.6; P = .009).
“Atrial arrhythmias were found in 26% of patients with sickle cell anemia, with a significant association with stroke history,” wrote the authors of the study. In a commentary published concurrently, Jonathan Uniat, MD, of Children’s Hospital Los Angeles in California, wrote, “Early detection and treatment of atrial arrhythmias may help prevent strokes in this population.”
SOURCE:
The study was led by Thomas d’Humières, Henri Mondor Hospital in Créteil, France. It was published online on November 12 in Blood Advances.
LIMITATIONS:
This study was a pilot prospective study and was underpowered with atrial arrhythmias occurring in only 34 patients. The population was relatively old for sickle cell anemia (45 years), and the study was biased because patients were selected based on clinical criteria indicative of underlying cardiovascular abnormalities. The population was heterogeneous in terms of antiarrhythmic therapy, and overall, at an advanced stage of the disease with frequent organ complications.
DISCLOSURES:
The study was supported by grants from FHU-SENEC. Pablo Bartolucci received grants from Addmedica, the Fabre Foundation, Novartis, and Bluebird in the past 36 months; received consulting fees from Addmedica, Novartis, Roche, GBT, Bluebird, Emmaus, Hemanext, and Agios; received honoraria for lectures from Novartis, Addmedica, and Jazz Pharmaceuticals; and reported being a member of the Novartis steering committee and cofounder of Innovhem. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- A total of 130 adult patients with SCD were included in the DREPACOEUR prospective registry from November 2018 to November 2022.
- The patients underwent a comprehensive cardiac evaluation, including 24-hour electrocardiogram monitoring, echocardiography, and laboratory tests.
- The primary endpoint was the occurrence of atrial arrhythmias, defined by excessive supraventricular ectopic activity or any recent history of atrial fibrillation.
- Patients with a history of stroke or transient ischemic attack were also included in the PCDREP prospective registry for further assessment.
- Written informed consent was collected from all participating patients, and the study was approved by the ethics committee.
TAKEAWAY:
- Atrial arrhythmias were found in 26% of patients with SCD, with a significant association with stroke history (P = .001).
- Age and left atrial volume were independently associated with atrial arrhythmias, with optimal cutoffs of 47 years and 55 mL/m2, respectively.
- Patients with atrial arrhythmias had higher diastolic blood pressure, worse kidney function, and higher NT pro-BNP levels than those without arrhythmias.
- Atrial arrhythmias were associated with an increased risk for stroke unrelated to cerebral vasculopathy or other defined causes (odds ratio, 6.6; P = .009).
“Atrial arrhythmias were found in 26% of patients with sickle cell anemia, with a significant association with stroke history,” wrote the authors of the study. In a commentary published concurrently, Jonathan Uniat, MD, of Children’s Hospital Los Angeles in California, wrote, “Early detection and treatment of atrial arrhythmias may help prevent strokes in this population.”
SOURCE:
The study was led by Thomas d’Humières, Henri Mondor Hospital in Créteil, France. It was published online on November 12 in Blood Advances.
LIMITATIONS:
This study was a pilot prospective study and was underpowered with atrial arrhythmias occurring in only 34 patients. The population was relatively old for sickle cell anemia (45 years), and the study was biased because patients were selected based on clinical criteria indicative of underlying cardiovascular abnormalities. The population was heterogeneous in terms of antiarrhythmic therapy, and overall, at an advanced stage of the disease with frequent organ complications.
DISCLOSURES:
The study was supported by grants from FHU-SENEC. Pablo Bartolucci received grants from Addmedica, the Fabre Foundation, Novartis, and Bluebird in the past 36 months; received consulting fees from Addmedica, Novartis, Roche, GBT, Bluebird, Emmaus, Hemanext, and Agios; received honoraria for lectures from Novartis, Addmedica, and Jazz Pharmaceuticals; and reported being a member of the Novartis steering committee and cofounder of Innovhem. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- A total of 130 adult patients with SCD were included in the DREPACOEUR prospective registry from November 2018 to November 2022.
- The patients underwent a comprehensive cardiac evaluation, including 24-hour electrocardiogram monitoring, echocardiography, and laboratory tests.
- The primary endpoint was the occurrence of atrial arrhythmias, defined by excessive supraventricular ectopic activity or any recent history of atrial fibrillation.
- Patients with a history of stroke or transient ischemic attack were also included in the PCDREP prospective registry for further assessment.
- Written informed consent was collected from all participating patients, and the study was approved by the ethics committee.
TAKEAWAY:
- Atrial arrhythmias were found in 26% of patients with SCD, with a significant association with stroke history (P = .001).
- Age and left atrial volume were independently associated with atrial arrhythmias, with optimal cutoffs of 47 years and 55 mL/m2, respectively.
- Patients with atrial arrhythmias had higher diastolic blood pressure, worse kidney function, and higher NT pro-BNP levels than those without arrhythmias.
- Atrial arrhythmias were associated with an increased risk for stroke unrelated to cerebral vasculopathy or other defined causes (odds ratio, 6.6; P = .009).
“Atrial arrhythmias were found in 26% of patients with sickle cell anemia, with a significant association with stroke history,” wrote the authors of the study. In a commentary published concurrently, Jonathan Uniat, MD, of Children’s Hospital Los Angeles in California, wrote, “Early detection and treatment of atrial arrhythmias may help prevent strokes in this population.”
SOURCE:
The study was led by Thomas d’Humières, Henri Mondor Hospital in Créteil, France. It was published online on November 12 in Blood Advances.
LIMITATIONS:
This study was a pilot prospective study and was underpowered with atrial arrhythmias occurring in only 34 patients. The population was relatively old for sickle cell anemia (45 years), and the study was biased because patients were selected based on clinical criteria indicative of underlying cardiovascular abnormalities. The population was heterogeneous in terms of antiarrhythmic therapy, and overall, at an advanced stage of the disease with frequent organ complications.
DISCLOSURES:
The study was supported by grants from FHU-SENEC. Pablo Bartolucci received grants from Addmedica, the Fabre Foundation, Novartis, and Bluebird in the past 36 months; received consulting fees from Addmedica, Novartis, Roche, GBT, Bluebird, Emmaus, Hemanext, and Agios; received honoraria for lectures from Novartis, Addmedica, and Jazz Pharmaceuticals; and reported being a member of the Novartis steering committee and cofounder of Innovhem. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Study Finds No Significant Effect of Low-Dose Oral Minoxidil on BP
TOPLINE:
but is associated with a slight increase in heart rate and a 5% incidence of hypotensive symptoms.
METHODOLOGY:
- Researchers conducted a systematic review and meta-analysis of 16 studies, which involved 2387 patients with alopecia (60.7% women) who received minoxidil, a vasodilator originally developed as an antihypertensive, at doses of 5 mg or less per day.
- Outcomes included changes in mean arterial pressure, systolic BP, diastolic BP, and heart rate.
- Mean differences were calculated between pretreatment and posttreatment values.
TAKEAWAY:
- Hypotensive symptoms were reported in 5% patients, with no significant hypotensive episodes. About 1.8% patients experienced lightheadedness or syncope, 1.2% experienced dizziness, 0.9% had tachycardia, and 0.8% had palpitations.
- LDOM did not significantly alter systolic BP (mean difference, –0.13; 95% CI, –2.67 to 2.41), diastolic BP (mean difference, –1.25; 95% CI, –3.21 to 0.71), and mean arterial pressure (mean difference, –1.92; 95% CI, –4.00 to 0.17).
- LDOM led to a significant increase in heart rate (mean difference, 2.67 beats/min; 95% CI, 0.34-5.01), a difference the authors wrote would “likely not be clinically significant for most patients.”
- Hypertrichosis was the most common side effect (59.6%) and reason for stopping treatment (accounting for nearly 35% of discontinuations).
IN PRACTICE:
“LDOM appears to be a safe treatment for alopecia with no significant impact on blood pressure,” the authors wrote, noting that the study “addresses gaps in clinical knowledge involving LDOM.” Based on their results, they recommended that BP and heart rate “do not need to be closely monitored in patients without prior cardiovascular risk history.”
SOURCE:
The study was led by Matthew Chen, BS, Stony Brook Dermatology in New York. It was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The studies included had small sample sizes and retrospective designs, which may limit the reliability of the findings. Additional limitations include the absence of control groups, a potential recall bias in adverse effect reporting, and variability in dosing regimens and BP monitoring.
DISCLOSURES:
The authors reported no external funding or conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
but is associated with a slight increase in heart rate and a 5% incidence of hypotensive symptoms.
METHODOLOGY:
- Researchers conducted a systematic review and meta-analysis of 16 studies, which involved 2387 patients with alopecia (60.7% women) who received minoxidil, a vasodilator originally developed as an antihypertensive, at doses of 5 mg or less per day.
- Outcomes included changes in mean arterial pressure, systolic BP, diastolic BP, and heart rate.
- Mean differences were calculated between pretreatment and posttreatment values.
TAKEAWAY:
- Hypotensive symptoms were reported in 5% patients, with no significant hypotensive episodes. About 1.8% patients experienced lightheadedness or syncope, 1.2% experienced dizziness, 0.9% had tachycardia, and 0.8% had palpitations.
- LDOM did not significantly alter systolic BP (mean difference, –0.13; 95% CI, –2.67 to 2.41), diastolic BP (mean difference, –1.25; 95% CI, –3.21 to 0.71), and mean arterial pressure (mean difference, –1.92; 95% CI, –4.00 to 0.17).
- LDOM led to a significant increase in heart rate (mean difference, 2.67 beats/min; 95% CI, 0.34-5.01), a difference the authors wrote would “likely not be clinically significant for most patients.”
- Hypertrichosis was the most common side effect (59.6%) and reason for stopping treatment (accounting for nearly 35% of discontinuations).
IN PRACTICE:
“LDOM appears to be a safe treatment for alopecia with no significant impact on blood pressure,” the authors wrote, noting that the study “addresses gaps in clinical knowledge involving LDOM.” Based on their results, they recommended that BP and heart rate “do not need to be closely monitored in patients without prior cardiovascular risk history.”
SOURCE:
The study was led by Matthew Chen, BS, Stony Brook Dermatology in New York. It was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The studies included had small sample sizes and retrospective designs, which may limit the reliability of the findings. Additional limitations include the absence of control groups, a potential recall bias in adverse effect reporting, and variability in dosing regimens and BP monitoring.
DISCLOSURES:
The authors reported no external funding or conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
but is associated with a slight increase in heart rate and a 5% incidence of hypotensive symptoms.
METHODOLOGY:
- Researchers conducted a systematic review and meta-analysis of 16 studies, which involved 2387 patients with alopecia (60.7% women) who received minoxidil, a vasodilator originally developed as an antihypertensive, at doses of 5 mg or less per day.
- Outcomes included changes in mean arterial pressure, systolic BP, diastolic BP, and heart rate.
- Mean differences were calculated between pretreatment and posttreatment values.
TAKEAWAY:
- Hypotensive symptoms were reported in 5% patients, with no significant hypotensive episodes. About 1.8% patients experienced lightheadedness or syncope, 1.2% experienced dizziness, 0.9% had tachycardia, and 0.8% had palpitations.
- LDOM did not significantly alter systolic BP (mean difference, –0.13; 95% CI, –2.67 to 2.41), diastolic BP (mean difference, –1.25; 95% CI, –3.21 to 0.71), and mean arterial pressure (mean difference, –1.92; 95% CI, –4.00 to 0.17).
- LDOM led to a significant increase in heart rate (mean difference, 2.67 beats/min; 95% CI, 0.34-5.01), a difference the authors wrote would “likely not be clinically significant for most patients.”
- Hypertrichosis was the most common side effect (59.6%) and reason for stopping treatment (accounting for nearly 35% of discontinuations).
IN PRACTICE:
“LDOM appears to be a safe treatment for alopecia with no significant impact on blood pressure,” the authors wrote, noting that the study “addresses gaps in clinical knowledge involving LDOM.” Based on their results, they recommended that BP and heart rate “do not need to be closely monitored in patients without prior cardiovascular risk history.”
SOURCE:
The study was led by Matthew Chen, BS, Stony Brook Dermatology in New York. It was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The studies included had small sample sizes and retrospective designs, which may limit the reliability of the findings. Additional limitations include the absence of control groups, a potential recall bias in adverse effect reporting, and variability in dosing regimens and BP monitoring.
DISCLOSURES:
The authors reported no external funding or conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Heat Waves Pose Significant Health Risks for Dually Eligible Older Individuals
TOPLINE:
Heat waves are associated with an increase in heat-related emergency department visits, hospitalizations, and deaths among dually eligible individuals older than 65 years.
METHODOLOGY:
- The researchers conducted a retrospective time-series study using national Medicare and Medicaid data from 2016 to 2019 to assess the link between heat waves during warm months and adverse health events.
- A total of 5,448,499 dually eligible individuals (66% women; 20% aged ≥ 85 years) were included from 28,404 zip code areas across 50 states and Washington, DC.
- Heat waves were defined as three or more consecutive days of extreme heat with a maximum temperature of at least 90 °F and within the 97th percentile of daily maximum temperatures for each zip code.
- Primary outcomes were daily counts of heat-related emergency department visits and hospitalizations.
- Secondary outcomes were all-cause and heat-specific emergency department visits, all-cause and heat-specific hospitalizations, deaths, and long-term nursing facility placements within 3 months after a heat wave.
TAKEAWAY:
- Heat waves were associated with a 10% increase in heat-related emergency department visits (incidence rate ratio [IRR], 1.10; 95% CI, 1.08-1.12) and a 7% increase in heat-related hospitalizations (IRR, 1.07; 95% CI, 1.04-1.09).
- Mortality rates were 4% higher during heat wave days than during non–heat wave days (IRR, 1.04; 95% CI, 1.01-1.07).
- No significant difference was found in rates of long-term nursing facility placements or heat-related emergency department visits for nursing facility residents.
- All racial and ethnic groups showed higher incidence rates of heat-related emergency department visits during heat waves, especially among beneficiaries identified as Asian (IRR, 1.21; 95% CI, 1.12-1.29). Rates were higher among individuals residing in the Northwest, Ohio Valley, and the West.
IN PRACTICE:
“In healthcare settings, clinicians should incorporate routine heat wave risk assessments into clinical practice, especially in regions more susceptible to extreme heat, for all dual-eligible beneficiaries and other at-risk patients,” wrote Jose F. Figueroa, MD, MPH, of the Harvard T.H. Chan School of Public Health in Boston, in an invited commentary. “Beyond offering preventive advice, clinicians can adjust medications that may increase their patients’ susceptibility during heat waves, or they can refer patients to social workers and social service organizations to ensure that they are protected at home.”
SOURCE:
This study was led by Hyunjee Kim, PhD, of the Center for Health Systems Effectiveness at Oregon Health & Science University, Portland. It was published online in JAMA Health Forum.
LIMITATIONS:
This study relied on a claims database to identify adverse events, which may have led to omissions in coding, particularly for heat-related conditions if the diagnostic codes for heat-related symptoms had not been adopted. This study did not adjust for variations in air quality or green space, which could have confounded the association of interest. Indoor heat exposures or adaptive behaviors, such as air conditioning use, were not considered. The analysis could not compare the association of heat waves with adverse events between those with dual eligibility and those without dual eligibility.
DISCLOSURES:
This study was supported by the National Institute on Aging. One author reported receiving grants from the National Institutes of Health outside the submitted work. No other disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Heat waves are associated with an increase in heat-related emergency department visits, hospitalizations, and deaths among dually eligible individuals older than 65 years.
METHODOLOGY:
- The researchers conducted a retrospective time-series study using national Medicare and Medicaid data from 2016 to 2019 to assess the link between heat waves during warm months and adverse health events.
- A total of 5,448,499 dually eligible individuals (66% women; 20% aged ≥ 85 years) were included from 28,404 zip code areas across 50 states and Washington, DC.
- Heat waves were defined as three or more consecutive days of extreme heat with a maximum temperature of at least 90 °F and within the 97th percentile of daily maximum temperatures for each zip code.
- Primary outcomes were daily counts of heat-related emergency department visits and hospitalizations.
- Secondary outcomes were all-cause and heat-specific emergency department visits, all-cause and heat-specific hospitalizations, deaths, and long-term nursing facility placements within 3 months after a heat wave.
TAKEAWAY:
- Heat waves were associated with a 10% increase in heat-related emergency department visits (incidence rate ratio [IRR], 1.10; 95% CI, 1.08-1.12) and a 7% increase in heat-related hospitalizations (IRR, 1.07; 95% CI, 1.04-1.09).
- Mortality rates were 4% higher during heat wave days than during non–heat wave days (IRR, 1.04; 95% CI, 1.01-1.07).
- No significant difference was found in rates of long-term nursing facility placements or heat-related emergency department visits for nursing facility residents.
- All racial and ethnic groups showed higher incidence rates of heat-related emergency department visits during heat waves, especially among beneficiaries identified as Asian (IRR, 1.21; 95% CI, 1.12-1.29). Rates were higher among individuals residing in the Northwest, Ohio Valley, and the West.
IN PRACTICE:
“In healthcare settings, clinicians should incorporate routine heat wave risk assessments into clinical practice, especially in regions more susceptible to extreme heat, for all dual-eligible beneficiaries and other at-risk patients,” wrote Jose F. Figueroa, MD, MPH, of the Harvard T.H. Chan School of Public Health in Boston, in an invited commentary. “Beyond offering preventive advice, clinicians can adjust medications that may increase their patients’ susceptibility during heat waves, or they can refer patients to social workers and social service organizations to ensure that they are protected at home.”
SOURCE:
This study was led by Hyunjee Kim, PhD, of the Center for Health Systems Effectiveness at Oregon Health & Science University, Portland. It was published online in JAMA Health Forum.
LIMITATIONS:
This study relied on a claims database to identify adverse events, which may have led to omissions in coding, particularly for heat-related conditions if the diagnostic codes for heat-related symptoms had not been adopted. This study did not adjust for variations in air quality or green space, which could have confounded the association of interest. Indoor heat exposures or adaptive behaviors, such as air conditioning use, were not considered. The analysis could not compare the association of heat waves with adverse events between those with dual eligibility and those without dual eligibility.
DISCLOSURES:
This study was supported by the National Institute on Aging. One author reported receiving grants from the National Institutes of Health outside the submitted work. No other disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Heat waves are associated with an increase in heat-related emergency department visits, hospitalizations, and deaths among dually eligible individuals older than 65 years.
METHODOLOGY:
- The researchers conducted a retrospective time-series study using national Medicare and Medicaid data from 2016 to 2019 to assess the link between heat waves during warm months and adverse health events.
- A total of 5,448,499 dually eligible individuals (66% women; 20% aged ≥ 85 years) were included from 28,404 zip code areas across 50 states and Washington, DC.
- Heat waves were defined as three or more consecutive days of extreme heat with a maximum temperature of at least 90 °F and within the 97th percentile of daily maximum temperatures for each zip code.
- Primary outcomes were daily counts of heat-related emergency department visits and hospitalizations.
- Secondary outcomes were all-cause and heat-specific emergency department visits, all-cause and heat-specific hospitalizations, deaths, and long-term nursing facility placements within 3 months after a heat wave.
TAKEAWAY:
- Heat waves were associated with a 10% increase in heat-related emergency department visits (incidence rate ratio [IRR], 1.10; 95% CI, 1.08-1.12) and a 7% increase in heat-related hospitalizations (IRR, 1.07; 95% CI, 1.04-1.09).
- Mortality rates were 4% higher during heat wave days than during non–heat wave days (IRR, 1.04; 95% CI, 1.01-1.07).
- No significant difference was found in rates of long-term nursing facility placements or heat-related emergency department visits for nursing facility residents.
- All racial and ethnic groups showed higher incidence rates of heat-related emergency department visits during heat waves, especially among beneficiaries identified as Asian (IRR, 1.21; 95% CI, 1.12-1.29). Rates were higher among individuals residing in the Northwest, Ohio Valley, and the West.
IN PRACTICE:
“In healthcare settings, clinicians should incorporate routine heat wave risk assessments into clinical practice, especially in regions more susceptible to extreme heat, for all dual-eligible beneficiaries and other at-risk patients,” wrote Jose F. Figueroa, MD, MPH, of the Harvard T.H. Chan School of Public Health in Boston, in an invited commentary. “Beyond offering preventive advice, clinicians can adjust medications that may increase their patients’ susceptibility during heat waves, or they can refer patients to social workers and social service organizations to ensure that they are protected at home.”
SOURCE:
This study was led by Hyunjee Kim, PhD, of the Center for Health Systems Effectiveness at Oregon Health & Science University, Portland. It was published online in JAMA Health Forum.
LIMITATIONS:
This study relied on a claims database to identify adverse events, which may have led to omissions in coding, particularly for heat-related conditions if the diagnostic codes for heat-related symptoms had not been adopted. This study did not adjust for variations in air quality or green space, which could have confounded the association of interest. Indoor heat exposures or adaptive behaviors, such as air conditioning use, were not considered. The analysis could not compare the association of heat waves with adverse events between those with dual eligibility and those without dual eligibility.
DISCLOSURES:
This study was supported by the National Institute on Aging. One author reported receiving grants from the National Institutes of Health outside the submitted work. No other disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Study Finds No Increased MACE Risk for JAK Inhibitors in Patients With Atopic Dermatitis
, suggested the results of a large, US-based, retrospective cohort study.
This holds true even in individuals aged 50 years or older, whose age puts them at increased cardiovascular (CV) risk, said Amina El Ayadi, PhD, of the University of Texas Medical Branch at Galveston. He presented the findings at the recent European Academy of Dermatology and Venereology (EADV) 2024 Congress.
Specifically, the analysis looked at treatment with the oral JAK1 inhibitors upadacitinib (Rinvoq) and abrocitinib (Cibinqo), both approved for treating AD in the United States, and found that the relative risk for MACE, such as acute myocardial infarction, cardiac arrest, stroke, or acute deep vein thrombosis, was ≤ 1.0 compared with those not treated with a JAKi.
Similarly, the relative risk for other CV safety endpoints, such as having an abnormal ECG or pericardial effusion, was also around 1.0. There was a slight increase in the relative risk for arrhythmias, peripheral edema, angina pectoris, or heart failure, but no value went > 1.6 and CIs spanned 1.0, indicating the results lack statistical significance.
Reassurance for Dermatologists?
“This suggests that oral administration of these drugs to the patient with atopic dermatitis does not increase the risk of major adverse cardiac events, and dermatologists, based on our data, can safely consider JAK inhibitors for treating moderate to severe dermatitis, even in patients with high risk for these diseases,” El Ayadi said during a late-breaking news session at the meeting.
Yolanda Gilaberte Calzada, MD, PhD, head of the Dermatology Department at Miguel Servet University Hospital in Zaragoza, Spain, who was one of the chairs for the session, said that this was “very good news for us.”
Gilaberte Calzada, president of the Spanish Academy of Dermatology and Venereology, asked if there were any data on the duration of treatment with the two JAKis included in the analysis. El Ayadi said that this was something that would be looked at in future data analyses.
Gilaberte Calzada also observed that because the CIs were wide, with more time, “we will have more defined data.”
Analyses Overview
For the two analyses — one in the overall population of patients with AD and the other in those aged 50 years or older — electronic medical record (EMR) data from the TriNetX Research Network were used. This is a global, federated health research network that contains EMRs for more than 275 million patients from over 120 healthcare organizations, El Ayadi explained.
To perform the analyses, the research team queried the TriNetX database to find all patients diagnosed with AD via the International Classification of Diseases, Tenth Revision code L20. They then determined if patients had been treated with JAKi or not, and specifically, with upadacitinib or abrocitinib. Those who had not received any JAKi treatment were the control population.
For the first analysis, no age-specific filter was applied. The investigators identified 1674 people with AD who had been treated with the JAKis and around 1.2 million who had not. Propensity score matching, based on age at diagnosis, biologic sex, and CV comorbidities, was performed to give a total of 1674 patients who had and 1674 who had not been treated with these medications.
In the second analysis, only those aged 50 years or older were considered; 875 patients who had received JAKi treatment were identified and around 250,000 who had not. Propensity score matching based on the same variables gave two groups of 875 people who had or had not taken a JAKi.
Queried over the age cutoff used, El Ayadi noted, “We did an analysis looking at patients 65 and older. However, we came up with lower patient numbers. … We do have this data, and we did not see any significant risk.”
The study was independently supported. El Ayadi and Gilaberte Calzada reported no conflicts of interest in relation to the presented findings.
A version of this article first appeared on Medscape.com.
, suggested the results of a large, US-based, retrospective cohort study.
This holds true even in individuals aged 50 years or older, whose age puts them at increased cardiovascular (CV) risk, said Amina El Ayadi, PhD, of the University of Texas Medical Branch at Galveston. He presented the findings at the recent European Academy of Dermatology and Venereology (EADV) 2024 Congress.
Specifically, the analysis looked at treatment with the oral JAK1 inhibitors upadacitinib (Rinvoq) and abrocitinib (Cibinqo), both approved for treating AD in the United States, and found that the relative risk for MACE, such as acute myocardial infarction, cardiac arrest, stroke, or acute deep vein thrombosis, was ≤ 1.0 compared with those not treated with a JAKi.
Similarly, the relative risk for other CV safety endpoints, such as having an abnormal ECG or pericardial effusion, was also around 1.0. There was a slight increase in the relative risk for arrhythmias, peripheral edema, angina pectoris, or heart failure, but no value went > 1.6 and CIs spanned 1.0, indicating the results lack statistical significance.
Reassurance for Dermatologists?
“This suggests that oral administration of these drugs to the patient with atopic dermatitis does not increase the risk of major adverse cardiac events, and dermatologists, based on our data, can safely consider JAK inhibitors for treating moderate to severe dermatitis, even in patients with high risk for these diseases,” El Ayadi said during a late-breaking news session at the meeting.
Yolanda Gilaberte Calzada, MD, PhD, head of the Dermatology Department at Miguel Servet University Hospital in Zaragoza, Spain, who was one of the chairs for the session, said that this was “very good news for us.”
Gilaberte Calzada, president of the Spanish Academy of Dermatology and Venereology, asked if there were any data on the duration of treatment with the two JAKis included in the analysis. El Ayadi said that this was something that would be looked at in future data analyses.
Gilaberte Calzada also observed that because the CIs were wide, with more time, “we will have more defined data.”
Analyses Overview
For the two analyses — one in the overall population of patients with AD and the other in those aged 50 years or older — electronic medical record (EMR) data from the TriNetX Research Network were used. This is a global, federated health research network that contains EMRs for more than 275 million patients from over 120 healthcare organizations, El Ayadi explained.
To perform the analyses, the research team queried the TriNetX database to find all patients diagnosed with AD via the International Classification of Diseases, Tenth Revision code L20. They then determined if patients had been treated with JAKi or not, and specifically, with upadacitinib or abrocitinib. Those who had not received any JAKi treatment were the control population.
For the first analysis, no age-specific filter was applied. The investigators identified 1674 people with AD who had been treated with the JAKis and around 1.2 million who had not. Propensity score matching, based on age at diagnosis, biologic sex, and CV comorbidities, was performed to give a total of 1674 patients who had and 1674 who had not been treated with these medications.
In the second analysis, only those aged 50 years or older were considered; 875 patients who had received JAKi treatment were identified and around 250,000 who had not. Propensity score matching based on the same variables gave two groups of 875 people who had or had not taken a JAKi.
Queried over the age cutoff used, El Ayadi noted, “We did an analysis looking at patients 65 and older. However, we came up with lower patient numbers. … We do have this data, and we did not see any significant risk.”
The study was independently supported. El Ayadi and Gilaberte Calzada reported no conflicts of interest in relation to the presented findings.
A version of this article first appeared on Medscape.com.
, suggested the results of a large, US-based, retrospective cohort study.
This holds true even in individuals aged 50 years or older, whose age puts them at increased cardiovascular (CV) risk, said Amina El Ayadi, PhD, of the University of Texas Medical Branch at Galveston. He presented the findings at the recent European Academy of Dermatology and Venereology (EADV) 2024 Congress.
Specifically, the analysis looked at treatment with the oral JAK1 inhibitors upadacitinib (Rinvoq) and abrocitinib (Cibinqo), both approved for treating AD in the United States, and found that the relative risk for MACE, such as acute myocardial infarction, cardiac arrest, stroke, or acute deep vein thrombosis, was ≤ 1.0 compared with those not treated with a JAKi.
Similarly, the relative risk for other CV safety endpoints, such as having an abnormal ECG or pericardial effusion, was also around 1.0. There was a slight increase in the relative risk for arrhythmias, peripheral edema, angina pectoris, or heart failure, but no value went > 1.6 and CIs spanned 1.0, indicating the results lack statistical significance.
Reassurance for Dermatologists?
“This suggests that oral administration of these drugs to the patient with atopic dermatitis does not increase the risk of major adverse cardiac events, and dermatologists, based on our data, can safely consider JAK inhibitors for treating moderate to severe dermatitis, even in patients with high risk for these diseases,” El Ayadi said during a late-breaking news session at the meeting.
Yolanda Gilaberte Calzada, MD, PhD, head of the Dermatology Department at Miguel Servet University Hospital in Zaragoza, Spain, who was one of the chairs for the session, said that this was “very good news for us.”
Gilaberte Calzada, president of the Spanish Academy of Dermatology and Venereology, asked if there were any data on the duration of treatment with the two JAKis included in the analysis. El Ayadi said that this was something that would be looked at in future data analyses.
Gilaberte Calzada also observed that because the CIs were wide, with more time, “we will have more defined data.”
Analyses Overview
For the two analyses — one in the overall population of patients with AD and the other in those aged 50 years or older — electronic medical record (EMR) data from the TriNetX Research Network were used. This is a global, federated health research network that contains EMRs for more than 275 million patients from over 120 healthcare organizations, El Ayadi explained.
To perform the analyses, the research team queried the TriNetX database to find all patients diagnosed with AD via the International Classification of Diseases, Tenth Revision code L20. They then determined if patients had been treated with JAKi or not, and specifically, with upadacitinib or abrocitinib. Those who had not received any JAKi treatment were the control population.
For the first analysis, no age-specific filter was applied. The investigators identified 1674 people with AD who had been treated with the JAKis and around 1.2 million who had not. Propensity score matching, based on age at diagnosis, biologic sex, and CV comorbidities, was performed to give a total of 1674 patients who had and 1674 who had not been treated with these medications.
In the second analysis, only those aged 50 years or older were considered; 875 patients who had received JAKi treatment were identified and around 250,000 who had not. Propensity score matching based on the same variables gave two groups of 875 people who had or had not taken a JAKi.
Queried over the age cutoff used, El Ayadi noted, “We did an analysis looking at patients 65 and older. However, we came up with lower patient numbers. … We do have this data, and we did not see any significant risk.”
The study was independently supported. El Ayadi and Gilaberte Calzada reported no conflicts of interest in relation to the presented findings.
A version of this article first appeared on Medscape.com.
FROM EADV 2024
Rituximab Not Inferior to Cyclophosphamide in Pediatric Vasculitis
TOPLINE:
and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.
METHODOLOGY:
- Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
- A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
- The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
- The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.
TAKEAWAY:
- At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
- Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
- Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
- The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).
IN PRACTICE:
“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.
SOURCE:
This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.
LIMITATIONS:
Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.
DISCLOSURES:
This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.
METHODOLOGY:
- Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
- A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
- The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
- The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.
TAKEAWAY:
- At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
- Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
- Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
- The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).
IN PRACTICE:
“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.
SOURCE:
This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.
LIMITATIONS:
Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.
DISCLOSURES:
This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.
METHODOLOGY:
- Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
- A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
- The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
- The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.
TAKEAWAY:
- At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
- Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
- Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
- The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).
IN PRACTICE:
“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.
SOURCE:
This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.
LIMITATIONS:
Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.
DISCLOSURES:
This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.