Bringing you the latest news, research and reviews, exclusive interviews, podcasts, quizzes, and more.

Theme
medstat_surgery
mdsurg
Main menu
MD Surgery Main Menu
Explore menu
MD Surgery Explore Menu
Proclivity ID
18860001
Unpublish
Specialty Focus
Pain
Colon and Rectal
General Surgery
Plastic Surgery
Cardiothoracic
Negative Keywords Excluded Elements
header[@id='header']
div[contains(@class, 'header__large-screen')]
div[contains(@class, 'read-next-article')]
div[contains(@class, 'nav-primary')]
nav[contains(@class, 'nav-primary')]
section[contains(@class, 'footer-nav-section-wrapper')]
footer[@id='footer']
div[contains(@class, 'main-prefix')]
section[contains(@class, 'nav-hidden')]
div[contains(@class, 'ce-card-content')]
nav[contains(@class, 'nav-ce-stack')]
Altmetric
Click for Credit Button Label
Click For Credit
DSM Affiliated
Display in offset block
Enable Disqus
Display Author and Disclosure Link
Publication Type
News
Slot System
Featured Buckets
Disable Sticky Ads
Disable Ad Block Mitigation
Featured Buckets Admin
Show Ads on this Publication's Homepage
Consolidated Pub
Show Article Page Numbers on TOC
Use larger logo size
On
publication_blueconic_enabled
Off
Show More Destinations Menu
Disable Adhesion on Publication
Off
Restore Menu Label on Mobile Navigation
Disable Facebook Pixel from Publication
Exclude this publication from publication selection on articles and quiz
Gating Strategy
First Peek Free
Challenge Center
Disable Inline Native ads

Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes

Article Type
Changed
Tue, 09/24/2024 - 13:12

 

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.

 

Thyme Care
Dr. Samyukta Mullangi

“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.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



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.

Publications
Topics
Sections

 

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.

 

Thyme Care
Dr. Samyukta Mullangi

“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.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



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.

 

Thyme Care
Dr. Samyukta Mullangi

“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.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



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.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Tue, 09/17/2024 - 19:11
Un-Gate On Date
Tue, 09/17/2024 - 19:11
Use ProPublica
CFC Schedule Remove Status
Tue, 09/17/2024 - 19:11
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Tue, 09/17/2024 - 19:11

Transplantation palliative care: The time is ripe

Article Type
Changed
Wed, 01/02/2019 - 09:44

 

Over 10 years ago, a challenge was made in a surgical publication for increased collaboration between the fields of transplantation and palliative care.1

Since that time not much progress has been made bringing these fields together in a consistent way that would mutually benefit patients and the specialties. However, other progress has been made, particularly in the field of palliative care, which could brighten the prospects and broaden the opportunities to accomplish collaboration between palliative care and transplantation.

Growth of palliative services

During the past decade there has been a robust proliferation of hospital-based palliative care programs in the United States. In all, 67% of U.S. hospitals with 50 or more beds report palliative care teams, up from 63% in 2011 and 53% in 2008.

Dr. Daniel Azoulay
In addition, the number of hospice and palliative medicine fellowship programs and certified physicians, including surgeons, has increased across the country. There are approximately 120 training fellowships in hospice and palliative medicine and more than 7,000 physicians certified in hospice and palliative medicine through the American Board of Medical Specialties and American Osteopathic Association.

Only a decade ago, critical care and palliative care were generally considered mutually exclusive. Evidence is trickling in to suggest that this is no longer the case. Although palliative care was not an integral part of critical care at that time, patients, families, and even practitioners began to demand these services. Cook and Rocker have eloquently advocated the rightful place of palliative care in the ICU.2

Studies in recent years have shown that the integration of palliative care into critical care decreases in length of ICU and hospital stay, decreases costs, enhances patient/family satisfaction, and promotes a more rapid consensus about goals of care, without increasing mortality. The ICU experience to date could be considered a reassuring precedent for transplantation palliative care.

Integration of palliative care with transplantation

Early palliative care intervention has been shown to improve symptom burden and depression scores in end-stage liver disease patients awaiting transplant. In addition, early palliative care consultation in conjunction with cancer treatment has been associated with increased survival in non–small-cell lung cancer patients. It has been demonstrated that early integration of palliative care in the surgical ICU alongside disease-directed curative care can be accomplished without change in mortality, while improving end-of-life practice in liver transplant patients.3

Dr. Geoffrey P. Dunn
Transplantation palliative care is a species of surgical palliative care, which is defined as the treatment of suffering and the promotion of quality of life for seriously or terminally ill patients under surgical care. Despite the dearth of information about palliative care for patients under the care of transplant surgeons, clearly there are few specialties with so many patients need of palliative care support. There is no “Stage I” disease in the world of transplantation. Any patient awaiting transplantation, any patient’s family considering organ donation from a critically ill loved one, and any transplant patient with chronic organ rejection or other significant morbidity is appropriate for palliative care consultation. Palliative care support addresses two needs critically important for successful transplantation outcomes: improved medical compliance that comes with diligent symptom control and psychosocial support.

What palliative care can do for transplant patients

What does palliative care mean for the person (and family) awaiting transplantation? For the cirrhotic patient with cachexia, ascites, and encephalopathy, it means access to the services of a team trained in the management of these symptoms. Palliative care teams can also provide psychosocial and spiritual support for patients and families who are intimidated by the complex navigation of the health care system and the existential threat that end-stage organ failure presents to them. Skilled palliative care and services can be the difference between failing and extended life with a higher quality of life for these very sick patients

Resuscitation of a patient, whether through restoration of organ function or interdicting the progression of disease, begins with resuscitation of hope. Nothing achieves this more quickly than amelioration of burdensome symptoms for the patient and family.

The barriers for transplant surgeons and teams referring and incorporating palliative care services in their practices are multiple and profound. The unique dilemma facing the transplant team is to balance the treatment of the failing organ, the treatment of the patient (and family and friends), and the best use of the graft, a precious gift of society.

Palliative surgery has been defined as any invasive procedure in which the main intention is to mitigate physical symptoms in patients with noncurable disease without causing premature death. The very success of transplantation over the past 3 decades has obscured our memory of transplantation as a type of palliative surgery. It is a well-known axiom of reconstructive surgery that the reconstructed site should be compared to what was there, not to “normal.” Even in the current era of improved immunosuppression and posttransplant support services, one could hardly describe even a successful transplant patient’s experience as “normal.” These patients’ lives may be extended and/or enhanced but they need palliative care before, during, and after transplantation. The growing availability of trained palliative care clinicians and teams, the increased familiarity of palliative and end-of-life care to surgical residents and fellows, and quality metrics measuring palliative care outcomes will provide reassurance and guidance to address reservations about the convergence of the two seemingly opposite realities.
 

 

 

A modest proposal

We propose that palliative care be presented to the entire spectrum of transplantation care: on the ward, in the ICU, and after transplantation. More specific “triggers” for palliative care for referral of transplant patients should be identified. Wentlandt et al.4 have described a promising model for an ambulatory clinic, which provides early, integrated palliative care to patients awaiting and receiving organ transplantation. In addition, we propose an application for grant funding for a conference and eventual formation of a work group of transplant surgeons and team members, palliative care clinicians, and patient/families who have experienced one of the aspects of the transplant spectrum. We await the subspecialty certification in hospice and palliative medicine of a transplant surgeon. Outside of transplantation, every other surgical specialty in the United States has diplomates certified in hospice and palliative medicine. We await the benefits that will accrue from research about the merging of these fields.

1. Molmenti EP, Dunn GP: Transplantation and palliative care: The convergence of two seemingly opposite realities. Surg Clin North Am. 2005;85:373-82.

2. Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014;370:2506-14.

3. Lamba S, Murphy P, McVicker S, Smith JH, and Mosenthal AC. Changing end-of-life care practice for liver transplant patients: structured palliative care intervention in the surgical intensive care unit. J Pain Symptom Manage. 2012; 44(4):508-19.

4. Wentlandt, K., Dall’Osto, A., Freeman, N., Le, L. W., Kaya, E., Ross, H., Singer, L. G., Abbey, S., Clarke, H. and Zimmermann, C. (2016), The Transplant Palliative Care Clinic: An early palliative care model for patients in a transplant program. Clin Transplant. 2016 Nov 4; doi: 10.1111/ctr.12838.

Dr. Azoulay is a transplantation specialist of Assistance Publique – Hôpitaux de Paris, and the University of Paris. Dr. Dunn is medical director of the Palliative Care Consultation Service at the University of Pittsburgh Medical Center Hamot, and vice-chair of the ACS Committee on Surgical Palliative Care.

Publications
Topics
Sections

 

Over 10 years ago, a challenge was made in a surgical publication for increased collaboration between the fields of transplantation and palliative care.1

Since that time not much progress has been made bringing these fields together in a consistent way that would mutually benefit patients and the specialties. However, other progress has been made, particularly in the field of palliative care, which could brighten the prospects and broaden the opportunities to accomplish collaboration between palliative care and transplantation.

Growth of palliative services

During the past decade there has been a robust proliferation of hospital-based palliative care programs in the United States. In all, 67% of U.S. hospitals with 50 or more beds report palliative care teams, up from 63% in 2011 and 53% in 2008.

Dr. Daniel Azoulay
In addition, the number of hospice and palliative medicine fellowship programs and certified physicians, including surgeons, has increased across the country. There are approximately 120 training fellowships in hospice and palliative medicine and more than 7,000 physicians certified in hospice and palliative medicine through the American Board of Medical Specialties and American Osteopathic Association.

Only a decade ago, critical care and palliative care were generally considered mutually exclusive. Evidence is trickling in to suggest that this is no longer the case. Although palliative care was not an integral part of critical care at that time, patients, families, and even practitioners began to demand these services. Cook and Rocker have eloquently advocated the rightful place of palliative care in the ICU.2

Studies in recent years have shown that the integration of palliative care into critical care decreases in length of ICU and hospital stay, decreases costs, enhances patient/family satisfaction, and promotes a more rapid consensus about goals of care, without increasing mortality. The ICU experience to date could be considered a reassuring precedent for transplantation palliative care.

Integration of palliative care with transplantation

Early palliative care intervention has been shown to improve symptom burden and depression scores in end-stage liver disease patients awaiting transplant. In addition, early palliative care consultation in conjunction with cancer treatment has been associated with increased survival in non–small-cell lung cancer patients. It has been demonstrated that early integration of palliative care in the surgical ICU alongside disease-directed curative care can be accomplished without change in mortality, while improving end-of-life practice in liver transplant patients.3

Dr. Geoffrey P. Dunn
Transplantation palliative care is a species of surgical palliative care, which is defined as the treatment of suffering and the promotion of quality of life for seriously or terminally ill patients under surgical care. Despite the dearth of information about palliative care for patients under the care of transplant surgeons, clearly there are few specialties with so many patients need of palliative care support. There is no “Stage I” disease in the world of transplantation. Any patient awaiting transplantation, any patient’s family considering organ donation from a critically ill loved one, and any transplant patient with chronic organ rejection or other significant morbidity is appropriate for palliative care consultation. Palliative care support addresses two needs critically important for successful transplantation outcomes: improved medical compliance that comes with diligent symptom control and psychosocial support.

What palliative care can do for transplant patients

What does palliative care mean for the person (and family) awaiting transplantation? For the cirrhotic patient with cachexia, ascites, and encephalopathy, it means access to the services of a team trained in the management of these symptoms. Palliative care teams can also provide psychosocial and spiritual support for patients and families who are intimidated by the complex navigation of the health care system and the existential threat that end-stage organ failure presents to them. Skilled palliative care and services can be the difference between failing and extended life with a higher quality of life for these very sick patients

Resuscitation of a patient, whether through restoration of organ function or interdicting the progression of disease, begins with resuscitation of hope. Nothing achieves this more quickly than amelioration of burdensome symptoms for the patient and family.

The barriers for transplant surgeons and teams referring and incorporating palliative care services in their practices are multiple and profound. The unique dilemma facing the transplant team is to balance the treatment of the failing organ, the treatment of the patient (and family and friends), and the best use of the graft, a precious gift of society.

Palliative surgery has been defined as any invasive procedure in which the main intention is to mitigate physical symptoms in patients with noncurable disease without causing premature death. The very success of transplantation over the past 3 decades has obscured our memory of transplantation as a type of palliative surgery. It is a well-known axiom of reconstructive surgery that the reconstructed site should be compared to what was there, not to “normal.” Even in the current era of improved immunosuppression and posttransplant support services, one could hardly describe even a successful transplant patient’s experience as “normal.” These patients’ lives may be extended and/or enhanced but they need palliative care before, during, and after transplantation. The growing availability of trained palliative care clinicians and teams, the increased familiarity of palliative and end-of-life care to surgical residents and fellows, and quality metrics measuring palliative care outcomes will provide reassurance and guidance to address reservations about the convergence of the two seemingly opposite realities.
 

 

 

A modest proposal

We propose that palliative care be presented to the entire spectrum of transplantation care: on the ward, in the ICU, and after transplantation. More specific “triggers” for palliative care for referral of transplant patients should be identified. Wentlandt et al.4 have described a promising model for an ambulatory clinic, which provides early, integrated palliative care to patients awaiting and receiving organ transplantation. In addition, we propose an application for grant funding for a conference and eventual formation of a work group of transplant surgeons and team members, palliative care clinicians, and patient/families who have experienced one of the aspects of the transplant spectrum. We await the subspecialty certification in hospice and palliative medicine of a transplant surgeon. Outside of transplantation, every other surgical specialty in the United States has diplomates certified in hospice and palliative medicine. We await the benefits that will accrue from research about the merging of these fields.

1. Molmenti EP, Dunn GP: Transplantation and palliative care: The convergence of two seemingly opposite realities. Surg Clin North Am. 2005;85:373-82.

2. Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014;370:2506-14.

3. Lamba S, Murphy P, McVicker S, Smith JH, and Mosenthal AC. Changing end-of-life care practice for liver transplant patients: structured palliative care intervention in the surgical intensive care unit. J Pain Symptom Manage. 2012; 44(4):508-19.

4. Wentlandt, K., Dall’Osto, A., Freeman, N., Le, L. W., Kaya, E., Ross, H., Singer, L. G., Abbey, S., Clarke, H. and Zimmermann, C. (2016), The Transplant Palliative Care Clinic: An early palliative care model for patients in a transplant program. Clin Transplant. 2016 Nov 4; doi: 10.1111/ctr.12838.

Dr. Azoulay is a transplantation specialist of Assistance Publique – Hôpitaux de Paris, and the University of Paris. Dr. Dunn is medical director of the Palliative Care Consultation Service at the University of Pittsburgh Medical Center Hamot, and vice-chair of the ACS Committee on Surgical Palliative Care.

 

Over 10 years ago, a challenge was made in a surgical publication for increased collaboration between the fields of transplantation and palliative care.1

Since that time not much progress has been made bringing these fields together in a consistent way that would mutually benefit patients and the specialties. However, other progress has been made, particularly in the field of palliative care, which could brighten the prospects and broaden the opportunities to accomplish collaboration between palliative care and transplantation.

Growth of palliative services

During the past decade there has been a robust proliferation of hospital-based palliative care programs in the United States. In all, 67% of U.S. hospitals with 50 or more beds report palliative care teams, up from 63% in 2011 and 53% in 2008.

Dr. Daniel Azoulay
In addition, the number of hospice and palliative medicine fellowship programs and certified physicians, including surgeons, has increased across the country. There are approximately 120 training fellowships in hospice and palliative medicine and more than 7,000 physicians certified in hospice and palliative medicine through the American Board of Medical Specialties and American Osteopathic Association.

Only a decade ago, critical care and palliative care were generally considered mutually exclusive. Evidence is trickling in to suggest that this is no longer the case. Although palliative care was not an integral part of critical care at that time, patients, families, and even practitioners began to demand these services. Cook and Rocker have eloquently advocated the rightful place of palliative care in the ICU.2

Studies in recent years have shown that the integration of palliative care into critical care decreases in length of ICU and hospital stay, decreases costs, enhances patient/family satisfaction, and promotes a more rapid consensus about goals of care, without increasing mortality. The ICU experience to date could be considered a reassuring precedent for transplantation palliative care.

Integration of palliative care with transplantation

Early palliative care intervention has been shown to improve symptom burden and depression scores in end-stage liver disease patients awaiting transplant. In addition, early palliative care consultation in conjunction with cancer treatment has been associated with increased survival in non–small-cell lung cancer patients. It has been demonstrated that early integration of palliative care in the surgical ICU alongside disease-directed curative care can be accomplished without change in mortality, while improving end-of-life practice in liver transplant patients.3

Dr. Geoffrey P. Dunn
Transplantation palliative care is a species of surgical palliative care, which is defined as the treatment of suffering and the promotion of quality of life for seriously or terminally ill patients under surgical care. Despite the dearth of information about palliative care for patients under the care of transplant surgeons, clearly there are few specialties with so many patients need of palliative care support. There is no “Stage I” disease in the world of transplantation. Any patient awaiting transplantation, any patient’s family considering organ donation from a critically ill loved one, and any transplant patient with chronic organ rejection or other significant morbidity is appropriate for palliative care consultation. Palliative care support addresses two needs critically important for successful transplantation outcomes: improved medical compliance that comes with diligent symptom control and psychosocial support.

What palliative care can do for transplant patients

What does palliative care mean for the person (and family) awaiting transplantation? For the cirrhotic patient with cachexia, ascites, and encephalopathy, it means access to the services of a team trained in the management of these symptoms. Palliative care teams can also provide psychosocial and spiritual support for patients and families who are intimidated by the complex navigation of the health care system and the existential threat that end-stage organ failure presents to them. Skilled palliative care and services can be the difference between failing and extended life with a higher quality of life for these very sick patients

Resuscitation of a patient, whether through restoration of organ function or interdicting the progression of disease, begins with resuscitation of hope. Nothing achieves this more quickly than amelioration of burdensome symptoms for the patient and family.

The barriers for transplant surgeons and teams referring and incorporating palliative care services in their practices are multiple and profound. The unique dilemma facing the transplant team is to balance the treatment of the failing organ, the treatment of the patient (and family and friends), and the best use of the graft, a precious gift of society.

Palliative surgery has been defined as any invasive procedure in which the main intention is to mitigate physical symptoms in patients with noncurable disease without causing premature death. The very success of transplantation over the past 3 decades has obscured our memory of transplantation as a type of palliative surgery. It is a well-known axiom of reconstructive surgery that the reconstructed site should be compared to what was there, not to “normal.” Even in the current era of improved immunosuppression and posttransplant support services, one could hardly describe even a successful transplant patient’s experience as “normal.” These patients’ lives may be extended and/or enhanced but they need palliative care before, during, and after transplantation. The growing availability of trained palliative care clinicians and teams, the increased familiarity of palliative and end-of-life care to surgical residents and fellows, and quality metrics measuring palliative care outcomes will provide reassurance and guidance to address reservations about the convergence of the two seemingly opposite realities.
 

 

 

A modest proposal

We propose that palliative care be presented to the entire spectrum of transplantation care: on the ward, in the ICU, and after transplantation. More specific “triggers” for palliative care for referral of transplant patients should be identified. Wentlandt et al.4 have described a promising model for an ambulatory clinic, which provides early, integrated palliative care to patients awaiting and receiving organ transplantation. In addition, we propose an application for grant funding for a conference and eventual formation of a work group of transplant surgeons and team members, palliative care clinicians, and patient/families who have experienced one of the aspects of the transplant spectrum. We await the subspecialty certification in hospice and palliative medicine of a transplant surgeon. Outside of transplantation, every other surgical specialty in the United States has diplomates certified in hospice and palliative medicine. We await the benefits that will accrue from research about the merging of these fields.

1. Molmenti EP, Dunn GP: Transplantation and palliative care: The convergence of two seemingly opposite realities. Surg Clin North Am. 2005;85:373-82.

2. Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014;370:2506-14.

3. Lamba S, Murphy P, McVicker S, Smith JH, and Mosenthal AC. Changing end-of-life care practice for liver transplant patients: structured palliative care intervention in the surgical intensive care unit. J Pain Symptom Manage. 2012; 44(4):508-19.

4. Wentlandt, K., Dall’Osto, A., Freeman, N., Le, L. W., Kaya, E., Ross, H., Singer, L. G., Abbey, S., Clarke, H. and Zimmermann, C. (2016), The Transplant Palliative Care Clinic: An early palliative care model for patients in a transplant program. Clin Transplant. 2016 Nov 4; doi: 10.1111/ctr.12838.

Dr. Azoulay is a transplantation specialist of Assistance Publique – Hôpitaux de Paris, and the University of Paris. Dr. Dunn is medical director of the Palliative Care Consultation Service at the University of Pittsburgh Medical Center Hamot, and vice-chair of the ACS Committee on Surgical Palliative Care.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Alternative CME

It’s Not Too Late for Influenza Vaccination: Q&A With CDC’s Dr. Lisa Grohskopf

Article Type
Changed
Wed, 11/27/2024 - 02:23

This news organization recently spoke with the Centers for Disease Control and Prevention’s (CDC) Lisa Grohskopf, MD, MPH, Influenza Division, National Center for Immunization and Respiratory Diseases, about what providers need to know regarding recommendations for influenza vaccination in the United States.

Text has been edited for length. 

 

Are there any updates to this season’s influenza vaccine or vaccine recommendations?

Yes, we have updates to both the vaccine and the vaccine recommendations this year. Typically we have some changes each year, and this year there are two main changes in the recommendations. One relates to the composition of the vaccine for this season, and the other is a new recommendation for adult solid organ transplant recipients. 

We typically have changes in the vaccine composition each season. For most seasons, one or more parts of the vaccine will change, but this year is a little different in that all of the vaccines available in the US for the 2024-2025 season are going to be three-virus, or trivalent, vaccines. They are going to be formulated to protect against three viruses: an influenza A(H1N1) virus, an influenza A(H3N2) virus, and an influenza B/Victoria lineage virus. 

The reason for this change is that since the 2013-2014 season through the 2023-2024 season, we had quadrivalent vaccines that were available in the US that contained four viruses. Those vaccines contained a second influenza B virus from the Yamagata lineage (B viruses come from two main lineages).

The reason for the change to trivalent vaccines this season is that influenza B/Yamagata viruses have not been detected in global surveillance since March 2020, and so their inclusion is no longer warranted. So this season, all of the vaccines available in the US are going to be trivalent.

In addition to that change, we have an update in the influenza A(H3N2) component of the vaccine compared with last season.

The second change concerning adult solid organ transplant recipients is that Advisory Committee on Immunization Practices (ACIP) now recommends that solid organ transplant recipients aged 18-64 years can receive as acceptable options either the high-dose inactivated vaccine or the adjuvanted inactivated vaccine without a preference over other age appropriate, inactivated, or recombinant vaccines.

Those vaccines are both formulated with features intended to make them more immunogenic — ie, promote a stronger immune response — and there are data for immunogenicity that suggest they could be more immunogenic in that population.

 

Who needs an influenza vaccine this season?

That recommendation is the same as it’s been for a number of years, which is that everybody aged 6 months or older is recommended to get a flu vaccine, with some rare exceptions, mainly concerning contraindications to vaccination. 

Contraindications are detailed in the ACIP flu statement each year, and they’re relatively uncommon conditions overall, so most people are recommended, if they’re in that age group 6 months and up, to get an annual flu vaccine.

Are there groups for whom influenza vaccination is especially important?

Yes. While influenza vaccination is recommended for everybody in that age group 6 months and up — and in truth, we can never really predict who’s going to get severely ill — some people are more likely to be at risk of having serious illness or hospitalization. Those people include adults aged 65 years or older; young children; people with certain chronic health conditions such as heart disease, lung disease, and diabetes; and people from some racial and ethnic groups.

 

Are there any specific influenza vaccination recommendations for these groups or others? 

Not for most people. In general, we have a number of different influenza vaccines each season; this year we have a total of nine brands. In general, there’s no preferential recommendation for one vaccine or type of vaccine for specific groups of people, with one exception: For people aged 65 years or older, there’s a preferential recommendation for three specific vaccines — the high-dose inactivated vaccine, Fluzone High-Dose; the recombinant vaccine, Flublok; and the adjuvanted inactivated vaccine, FLUAD. 

Among those three, there’s no preference for any one of them over the other two; they’re all preferred vaccines for this age group, if available. If none of those three vaccines are available at the time that somebody aged 65 or older is there to get vaccinated, people in this age group should get any other age-appropriate influenza vaccine that is available.

 

When should people get vaccinated if they haven’t already?

CDC and ACIP recommend vaccination for most people, ideally by the end of October. But for those who missed the end of October, it is absolutely not too late. Providers should continue to encourage vaccination and people should get their vaccines as long as flu viruses are circulating. 

The timing of the onset and the peak and the end of the flu season vary a bit from year to year. We often start to see generally activity begin to increase in the US in the fall, which is the reason for the end of October recommendation; however, flu activity doesn’t tend to peak in the US until after October. We’re talking December, January, or later, so getting vaccinated after October can still provide important protection during the peak of the season.

There does seem to be a tendency for people to think, OK, I haven’t gotten the vaccine yet, and there probably isn’t a lot of reason to do it now. But really, it’s definitely not too late, and that’s something we like to encourage people to think about, particularly as we move into December and January — it’s not too late if you missed October. 

Influenza vaccination is also available in so many places. You don’t necessarily have to go to a healthcare provider’s office; there are many retail chains which offer influenza vaccines.

 

Is influenza spreading right now? Are activity levels increasing?

Overall influenza activity currently is low nationally, although there’s starting to be some slight increases in the pediatric age groups and, of course, we do anticipate that it will increase in the coming weeks and months.

When we get vaccinated, the protection isn’t instantaneous. The immune system needs a bit of time to react to the vaccine and to develop antibodies. That can take about 2 weeks. Even with that, now is still absolutely not too late to get a vaccine. Neither is December, for that matter. As long as the flu viruses are circulating where you are, it is still worth getting vaccinated.

 

What was influenza vaccination coverage like last season?

It’s a little bit early to tell for the current season, but one of the things that we do know is that since the COVID-19 pandemic, coverage has dropped compared with before the COVID-19 pandemic. Before COVID-19, influenza vaccination coverage had been slowly increasing in most groups, but it has decreased since then, and those downturns in coverage haven’t recovered to prepandemic levels. For example, during 2023-2024, about half of children and adults received a flu vaccine. 

What can providers do to encourage influenza vaccination in their patients?

We know that a healthcare provider’s strong recommendation for flu vaccination is a really major factor in whether or not patients get a flu vaccine, and is more effective in increasing acceptance of vaccination than just about any other factor. 

There’s a method from CDC called SHARE, which is a helpful way to help make a strong recommendation and provide information to help patients make an informed decision about whether or not they want to be vaccinated.

To implement SHARE, it’s an acronym with five parts. S is for Share the reasons why the flu vaccine is right for that patient. H is for Highlight positive experiences with flu vaccination, either personal or in practice. A is for Address patient concerns and questions about the flu vaccine, including things such as side effects, safety, and effectiveness. R is Remind patients that vaccination protects them and their loved ones from serious illness and related complications. E is Explain the potential complications and consequences of getting influenza, including serious health effects, time lost from family, work, and school, and potential financial costs.

Additional resources are accessible on CDC’s influenza resources page, including brochures, posters, and fact sheets that can help providers in encouraging and reminding people to get vaccinated.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

This news organization recently spoke with the Centers for Disease Control and Prevention’s (CDC) Lisa Grohskopf, MD, MPH, Influenza Division, National Center for Immunization and Respiratory Diseases, about what providers need to know regarding recommendations for influenza vaccination in the United States.

Text has been edited for length. 

 

Are there any updates to this season’s influenza vaccine or vaccine recommendations?

Yes, we have updates to both the vaccine and the vaccine recommendations this year. Typically we have some changes each year, and this year there are two main changes in the recommendations. One relates to the composition of the vaccine for this season, and the other is a new recommendation for adult solid organ transplant recipients. 

We typically have changes in the vaccine composition each season. For most seasons, one or more parts of the vaccine will change, but this year is a little different in that all of the vaccines available in the US for the 2024-2025 season are going to be three-virus, or trivalent, vaccines. They are going to be formulated to protect against three viruses: an influenza A(H1N1) virus, an influenza A(H3N2) virus, and an influenza B/Victoria lineage virus. 

The reason for this change is that since the 2013-2014 season through the 2023-2024 season, we had quadrivalent vaccines that were available in the US that contained four viruses. Those vaccines contained a second influenza B virus from the Yamagata lineage (B viruses come from two main lineages).

The reason for the change to trivalent vaccines this season is that influenza B/Yamagata viruses have not been detected in global surveillance since March 2020, and so their inclusion is no longer warranted. So this season, all of the vaccines available in the US are going to be trivalent.

In addition to that change, we have an update in the influenza A(H3N2) component of the vaccine compared with last season.

The second change concerning adult solid organ transplant recipients is that Advisory Committee on Immunization Practices (ACIP) now recommends that solid organ transplant recipients aged 18-64 years can receive as acceptable options either the high-dose inactivated vaccine or the adjuvanted inactivated vaccine without a preference over other age appropriate, inactivated, or recombinant vaccines.

Those vaccines are both formulated with features intended to make them more immunogenic — ie, promote a stronger immune response — and there are data for immunogenicity that suggest they could be more immunogenic in that population.

 

Who needs an influenza vaccine this season?

That recommendation is the same as it’s been for a number of years, which is that everybody aged 6 months or older is recommended to get a flu vaccine, with some rare exceptions, mainly concerning contraindications to vaccination. 

Contraindications are detailed in the ACIP flu statement each year, and they’re relatively uncommon conditions overall, so most people are recommended, if they’re in that age group 6 months and up, to get an annual flu vaccine.

Are there groups for whom influenza vaccination is especially important?

Yes. While influenza vaccination is recommended for everybody in that age group 6 months and up — and in truth, we can never really predict who’s going to get severely ill — some people are more likely to be at risk of having serious illness or hospitalization. Those people include adults aged 65 years or older; young children; people with certain chronic health conditions such as heart disease, lung disease, and diabetes; and people from some racial and ethnic groups.

 

Are there any specific influenza vaccination recommendations for these groups or others? 

Not for most people. In general, we have a number of different influenza vaccines each season; this year we have a total of nine brands. In general, there’s no preferential recommendation for one vaccine or type of vaccine for specific groups of people, with one exception: For people aged 65 years or older, there’s a preferential recommendation for three specific vaccines — the high-dose inactivated vaccine, Fluzone High-Dose; the recombinant vaccine, Flublok; and the adjuvanted inactivated vaccine, FLUAD. 

Among those three, there’s no preference for any one of them over the other two; they’re all preferred vaccines for this age group, if available. If none of those three vaccines are available at the time that somebody aged 65 or older is there to get vaccinated, people in this age group should get any other age-appropriate influenza vaccine that is available.

 

When should people get vaccinated if they haven’t already?

CDC and ACIP recommend vaccination for most people, ideally by the end of October. But for those who missed the end of October, it is absolutely not too late. Providers should continue to encourage vaccination and people should get their vaccines as long as flu viruses are circulating. 

The timing of the onset and the peak and the end of the flu season vary a bit from year to year. We often start to see generally activity begin to increase in the US in the fall, which is the reason for the end of October recommendation; however, flu activity doesn’t tend to peak in the US until after October. We’re talking December, January, or later, so getting vaccinated after October can still provide important protection during the peak of the season.

There does seem to be a tendency for people to think, OK, I haven’t gotten the vaccine yet, and there probably isn’t a lot of reason to do it now. But really, it’s definitely not too late, and that’s something we like to encourage people to think about, particularly as we move into December and January — it’s not too late if you missed October. 

Influenza vaccination is also available in so many places. You don’t necessarily have to go to a healthcare provider’s office; there are many retail chains which offer influenza vaccines.

 

Is influenza spreading right now? Are activity levels increasing?

Overall influenza activity currently is low nationally, although there’s starting to be some slight increases in the pediatric age groups and, of course, we do anticipate that it will increase in the coming weeks and months.

When we get vaccinated, the protection isn’t instantaneous. The immune system needs a bit of time to react to the vaccine and to develop antibodies. That can take about 2 weeks. Even with that, now is still absolutely not too late to get a vaccine. Neither is December, for that matter. As long as the flu viruses are circulating where you are, it is still worth getting vaccinated.

 

What was influenza vaccination coverage like last season?

It’s a little bit early to tell for the current season, but one of the things that we do know is that since the COVID-19 pandemic, coverage has dropped compared with before the COVID-19 pandemic. Before COVID-19, influenza vaccination coverage had been slowly increasing in most groups, but it has decreased since then, and those downturns in coverage haven’t recovered to prepandemic levels. For example, during 2023-2024, about half of children and adults received a flu vaccine. 

What can providers do to encourage influenza vaccination in their patients?

We know that a healthcare provider’s strong recommendation for flu vaccination is a really major factor in whether or not patients get a flu vaccine, and is more effective in increasing acceptance of vaccination than just about any other factor. 

There’s a method from CDC called SHARE, which is a helpful way to help make a strong recommendation and provide information to help patients make an informed decision about whether or not they want to be vaccinated.

To implement SHARE, it’s an acronym with five parts. S is for Share the reasons why the flu vaccine is right for that patient. H is for Highlight positive experiences with flu vaccination, either personal or in practice. A is for Address patient concerns and questions about the flu vaccine, including things such as side effects, safety, and effectiveness. R is Remind patients that vaccination protects them and their loved ones from serious illness and related complications. E is Explain the potential complications and consequences of getting influenza, including serious health effects, time lost from family, work, and school, and potential financial costs.

Additional resources are accessible on CDC’s influenza resources page, including brochures, posters, and fact sheets that can help providers in encouraging and reminding people to get vaccinated.

A version of this article appeared on Medscape.com.

This news organization recently spoke with the Centers for Disease Control and Prevention’s (CDC) Lisa Grohskopf, MD, MPH, Influenza Division, National Center for Immunization and Respiratory Diseases, about what providers need to know regarding recommendations for influenza vaccination in the United States.

Text has been edited for length. 

 

Are there any updates to this season’s influenza vaccine or vaccine recommendations?

Yes, we have updates to both the vaccine and the vaccine recommendations this year. Typically we have some changes each year, and this year there are two main changes in the recommendations. One relates to the composition of the vaccine for this season, and the other is a new recommendation for adult solid organ transplant recipients. 

We typically have changes in the vaccine composition each season. For most seasons, one or more parts of the vaccine will change, but this year is a little different in that all of the vaccines available in the US for the 2024-2025 season are going to be three-virus, or trivalent, vaccines. They are going to be formulated to protect against three viruses: an influenza A(H1N1) virus, an influenza A(H3N2) virus, and an influenza B/Victoria lineage virus. 

The reason for this change is that since the 2013-2014 season through the 2023-2024 season, we had quadrivalent vaccines that were available in the US that contained four viruses. Those vaccines contained a second influenza B virus from the Yamagata lineage (B viruses come from two main lineages).

The reason for the change to trivalent vaccines this season is that influenza B/Yamagata viruses have not been detected in global surveillance since March 2020, and so their inclusion is no longer warranted. So this season, all of the vaccines available in the US are going to be trivalent.

In addition to that change, we have an update in the influenza A(H3N2) component of the vaccine compared with last season.

The second change concerning adult solid organ transplant recipients is that Advisory Committee on Immunization Practices (ACIP) now recommends that solid organ transplant recipients aged 18-64 years can receive as acceptable options either the high-dose inactivated vaccine or the adjuvanted inactivated vaccine without a preference over other age appropriate, inactivated, or recombinant vaccines.

Those vaccines are both formulated with features intended to make them more immunogenic — ie, promote a stronger immune response — and there are data for immunogenicity that suggest they could be more immunogenic in that population.

 

Who needs an influenza vaccine this season?

That recommendation is the same as it’s been for a number of years, which is that everybody aged 6 months or older is recommended to get a flu vaccine, with some rare exceptions, mainly concerning contraindications to vaccination. 

Contraindications are detailed in the ACIP flu statement each year, and they’re relatively uncommon conditions overall, so most people are recommended, if they’re in that age group 6 months and up, to get an annual flu vaccine.

Are there groups for whom influenza vaccination is especially important?

Yes. While influenza vaccination is recommended for everybody in that age group 6 months and up — and in truth, we can never really predict who’s going to get severely ill — some people are more likely to be at risk of having serious illness or hospitalization. Those people include adults aged 65 years or older; young children; people with certain chronic health conditions such as heart disease, lung disease, and diabetes; and people from some racial and ethnic groups.

 

Are there any specific influenza vaccination recommendations for these groups or others? 

Not for most people. In general, we have a number of different influenza vaccines each season; this year we have a total of nine brands. In general, there’s no preferential recommendation for one vaccine or type of vaccine for specific groups of people, with one exception: For people aged 65 years or older, there’s a preferential recommendation for three specific vaccines — the high-dose inactivated vaccine, Fluzone High-Dose; the recombinant vaccine, Flublok; and the adjuvanted inactivated vaccine, FLUAD. 

Among those three, there’s no preference for any one of them over the other two; they’re all preferred vaccines for this age group, if available. If none of those three vaccines are available at the time that somebody aged 65 or older is there to get vaccinated, people in this age group should get any other age-appropriate influenza vaccine that is available.

 

When should people get vaccinated if they haven’t already?

CDC and ACIP recommend vaccination for most people, ideally by the end of October. But for those who missed the end of October, it is absolutely not too late. Providers should continue to encourage vaccination and people should get their vaccines as long as flu viruses are circulating. 

The timing of the onset and the peak and the end of the flu season vary a bit from year to year. We often start to see generally activity begin to increase in the US in the fall, which is the reason for the end of October recommendation; however, flu activity doesn’t tend to peak in the US until after October. We’re talking December, January, or later, so getting vaccinated after October can still provide important protection during the peak of the season.

There does seem to be a tendency for people to think, OK, I haven’t gotten the vaccine yet, and there probably isn’t a lot of reason to do it now. But really, it’s definitely not too late, and that’s something we like to encourage people to think about, particularly as we move into December and January — it’s not too late if you missed October. 

Influenza vaccination is also available in so many places. You don’t necessarily have to go to a healthcare provider’s office; there are many retail chains which offer influenza vaccines.

 

Is influenza spreading right now? Are activity levels increasing?

Overall influenza activity currently is low nationally, although there’s starting to be some slight increases in the pediatric age groups and, of course, we do anticipate that it will increase in the coming weeks and months.

When we get vaccinated, the protection isn’t instantaneous. The immune system needs a bit of time to react to the vaccine and to develop antibodies. That can take about 2 weeks. Even with that, now is still absolutely not too late to get a vaccine. Neither is December, for that matter. As long as the flu viruses are circulating where you are, it is still worth getting vaccinated.

 

What was influenza vaccination coverage like last season?

It’s a little bit early to tell for the current season, but one of the things that we do know is that since the COVID-19 pandemic, coverage has dropped compared with before the COVID-19 pandemic. Before COVID-19, influenza vaccination coverage had been slowly increasing in most groups, but it has decreased since then, and those downturns in coverage haven’t recovered to prepandemic levels. For example, during 2023-2024, about half of children and adults received a flu vaccine. 

What can providers do to encourage influenza vaccination in their patients?

We know that a healthcare provider’s strong recommendation for flu vaccination is a really major factor in whether or not patients get a flu vaccine, and is more effective in increasing acceptance of vaccination than just about any other factor. 

There’s a method from CDC called SHARE, which is a helpful way to help make a strong recommendation and provide information to help patients make an informed decision about whether or not they want to be vaccinated.

To implement SHARE, it’s an acronym with five parts. S is for Share the reasons why the flu vaccine is right for that patient. H is for Highlight positive experiences with flu vaccination, either personal or in practice. A is for Address patient concerns and questions about the flu vaccine, including things such as side effects, safety, and effectiveness. R is Remind patients that vaccination protects them and their loved ones from serious illness and related complications. E is Explain the potential complications and consequences of getting influenza, including serious health effects, time lost from family, work, and school, and potential financial costs.

Additional resources are accessible on CDC’s influenza resources page, including brochures, posters, and fact sheets that can help providers in encouraging and reminding people to get vaccinated.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Mon, 11/25/2024 - 13:09
Un-Gate On Date
Mon, 11/25/2024 - 13:09
Use ProPublica
CFC Schedule Remove Status
Mon, 11/25/2024 - 13:09
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Mon, 11/25/2024 - 13:09

Which Breast Cancer Patients Can Skip Postop Radiotherapy?

Article Type
Changed
Wed, 11/27/2024 - 01:37

TOPLINE: 

The Profile for the Omission of Local Adjuvant Radiation (POLAR) biomarker, a 16-gene molecular signature, can help predict locoregional recurrence in patients with ER-positive early breast cancer following breast-conserving surgery as well as which patients will benefit most from adjuvant radiotherapy. Overall, patients with a high POLAR score derived a significant benefit from adjuvant radiotherapy, while those with a low score did not and might consider forgoing radiotherapy.

METHODOLOGY:

  • Radiation therapy after breast-conserving surgery has been shown to reduce the risk for locoregional recurrence and is a standard approach to manage early breast cancer. However, certain patients with low locoregional recurrence risks may not necessarily benefit from adjuvant radiation, but there has not been a commercially available molecular test to help identify which patients that might be.
  • In the current analysis, researchers assessed whether the POLAR biomarker test could reliably predict locoregional recurrence as well as identify patients who would not benefit from radiotherapy.
  • The meta-analysis used data from three randomized trials — Scottish Conservation Trial, SweBCG91-RT, and Princess Margaret RT trial — to validate the POLAR biomarker test in patients with low-risk, HR-positive, HER2-negative, node-negative breast cancer.
  • The analysis included 623 patients (ages 50-76), of whom 429 (69%) had high POLAR scores and 194 (31%) had low POLAR scores.
  • The primary endpoint was the time to locoregional recurrence, and secondary endpoints included evaluating POLAR as a prognostic factor for locoregional recurrence in patients without radiotherapy and effect of radiotherapy in patients with low and high POLAR scores.

TAKEAWAY:

  • Patients with high POLAR scores demonstrated a significant benefit from radiotherapy. The 10-year locoregional recurrence rate was 7% with radiotherapy vs 20% without radiotherapy (hazard ratio [HR], 0.37; P < .001).
  • Patients with low POLAR scores, however, did not experience a significant benefit from radiotherapy. In this group, the 10-year locoregional recurrence rates were similar with and without radiotherapy (7% vs 5%, respectively; HR, 0.92; P = .832), indicating that radiotherapy could potentially be omitted for these patients.
  • Among patients who did not receive radiotherapy (n = 309), higher POLAR scores predicted a greater risk for recurrence, suggesting the genomic signature has prognostic value. There is no evidence, however, that POLAR predicts radiotherapy benefit or predicts patients’ risk for distant metastases or mortality.

IN PRACTICE:

“This meta-analysis from three randomized controlled trials clearly demonstrates the clinical potential for POLAR to be used in smaller estrogen receptor positive node negative breast cancer patients to identify those women who do not appear to benefit from the use of post-operative adjuvant radiotherapy,” the authors wrote. “ This classifier is an important step towards molecularly-stratified targeting of the use of radiotherapy.”

SOURCE:

The study, led by Per Karlsson, MD, PhD, University of Gothenburg, Sweden, was published online in the Journal of the National Cancer Institute.

LIMITATIONS:

One cohort (SweBCG) had limited use of adjuvant systemic therapy, which could affect generalizability. Additionally, low numbers of patients with low POLAR scores in two trials could affect the observed benefit of radiotherapy.

DISCLOSURES:

This study was supported by the Breast Cancer Institute Fund (Edinburgh and Lothians Health Foundation), Canadian Institutes of Health Research, Exact Sciences Corporation, PFS Genomics, Swedish Cancer Society, and Swedish Research Council. One author reported being an employee and owning stock or stock options or patents with Exact Sciences. Several authors reported having various ties with various sources including Exact Sciences.

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.

Publications
Topics
Sections

TOPLINE: 

The Profile for the Omission of Local Adjuvant Radiation (POLAR) biomarker, a 16-gene molecular signature, can help predict locoregional recurrence in patients with ER-positive early breast cancer following breast-conserving surgery as well as which patients will benefit most from adjuvant radiotherapy. Overall, patients with a high POLAR score derived a significant benefit from adjuvant radiotherapy, while those with a low score did not and might consider forgoing radiotherapy.

METHODOLOGY:

  • Radiation therapy after breast-conserving surgery has been shown to reduce the risk for locoregional recurrence and is a standard approach to manage early breast cancer. However, certain patients with low locoregional recurrence risks may not necessarily benefit from adjuvant radiation, but there has not been a commercially available molecular test to help identify which patients that might be.
  • In the current analysis, researchers assessed whether the POLAR biomarker test could reliably predict locoregional recurrence as well as identify patients who would not benefit from radiotherapy.
  • The meta-analysis used data from three randomized trials — Scottish Conservation Trial, SweBCG91-RT, and Princess Margaret RT trial — to validate the POLAR biomarker test in patients with low-risk, HR-positive, HER2-negative, node-negative breast cancer.
  • The analysis included 623 patients (ages 50-76), of whom 429 (69%) had high POLAR scores and 194 (31%) had low POLAR scores.
  • The primary endpoint was the time to locoregional recurrence, and secondary endpoints included evaluating POLAR as a prognostic factor for locoregional recurrence in patients without radiotherapy and effect of radiotherapy in patients with low and high POLAR scores.

TAKEAWAY:

  • Patients with high POLAR scores demonstrated a significant benefit from radiotherapy. The 10-year locoregional recurrence rate was 7% with radiotherapy vs 20% without radiotherapy (hazard ratio [HR], 0.37; P < .001).
  • Patients with low POLAR scores, however, did not experience a significant benefit from radiotherapy. In this group, the 10-year locoregional recurrence rates were similar with and without radiotherapy (7% vs 5%, respectively; HR, 0.92; P = .832), indicating that radiotherapy could potentially be omitted for these patients.
  • Among patients who did not receive radiotherapy (n = 309), higher POLAR scores predicted a greater risk for recurrence, suggesting the genomic signature has prognostic value. There is no evidence, however, that POLAR predicts radiotherapy benefit or predicts patients’ risk for distant metastases or mortality.

IN PRACTICE:

“This meta-analysis from three randomized controlled trials clearly demonstrates the clinical potential for POLAR to be used in smaller estrogen receptor positive node negative breast cancer patients to identify those women who do not appear to benefit from the use of post-operative adjuvant radiotherapy,” the authors wrote. “ This classifier is an important step towards molecularly-stratified targeting of the use of radiotherapy.”

SOURCE:

The study, led by Per Karlsson, MD, PhD, University of Gothenburg, Sweden, was published online in the Journal of the National Cancer Institute.

LIMITATIONS:

One cohort (SweBCG) had limited use of adjuvant systemic therapy, which could affect generalizability. Additionally, low numbers of patients with low POLAR scores in two trials could affect the observed benefit of radiotherapy.

DISCLOSURES:

This study was supported by the Breast Cancer Institute Fund (Edinburgh and Lothians Health Foundation), Canadian Institutes of Health Research, Exact Sciences Corporation, PFS Genomics, Swedish Cancer Society, and Swedish Research Council. One author reported being an employee and owning stock or stock options or patents with Exact Sciences. Several authors reported having various ties with various sources including Exact Sciences.

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: 

The Profile for the Omission of Local Adjuvant Radiation (POLAR) biomarker, a 16-gene molecular signature, can help predict locoregional recurrence in patients with ER-positive early breast cancer following breast-conserving surgery as well as which patients will benefit most from adjuvant radiotherapy. Overall, patients with a high POLAR score derived a significant benefit from adjuvant radiotherapy, while those with a low score did not and might consider forgoing radiotherapy.

METHODOLOGY:

  • Radiation therapy after breast-conserving surgery has been shown to reduce the risk for locoregional recurrence and is a standard approach to manage early breast cancer. However, certain patients with low locoregional recurrence risks may not necessarily benefit from adjuvant radiation, but there has not been a commercially available molecular test to help identify which patients that might be.
  • In the current analysis, researchers assessed whether the POLAR biomarker test could reliably predict locoregional recurrence as well as identify patients who would not benefit from radiotherapy.
  • The meta-analysis used data from three randomized trials — Scottish Conservation Trial, SweBCG91-RT, and Princess Margaret RT trial — to validate the POLAR biomarker test in patients with low-risk, HR-positive, HER2-negative, node-negative breast cancer.
  • The analysis included 623 patients (ages 50-76), of whom 429 (69%) had high POLAR scores and 194 (31%) had low POLAR scores.
  • The primary endpoint was the time to locoregional recurrence, and secondary endpoints included evaluating POLAR as a prognostic factor for locoregional recurrence in patients without radiotherapy and effect of radiotherapy in patients with low and high POLAR scores.

TAKEAWAY:

  • Patients with high POLAR scores demonstrated a significant benefit from radiotherapy. The 10-year locoregional recurrence rate was 7% with radiotherapy vs 20% without radiotherapy (hazard ratio [HR], 0.37; P < .001).
  • Patients with low POLAR scores, however, did not experience a significant benefit from radiotherapy. In this group, the 10-year locoregional recurrence rates were similar with and without radiotherapy (7% vs 5%, respectively; HR, 0.92; P = .832), indicating that radiotherapy could potentially be omitted for these patients.
  • Among patients who did not receive radiotherapy (n = 309), higher POLAR scores predicted a greater risk for recurrence, suggesting the genomic signature has prognostic value. There is no evidence, however, that POLAR predicts radiotherapy benefit or predicts patients’ risk for distant metastases or mortality.

IN PRACTICE:

“This meta-analysis from three randomized controlled trials clearly demonstrates the clinical potential for POLAR to be used in smaller estrogen receptor positive node negative breast cancer patients to identify those women who do not appear to benefit from the use of post-operative adjuvant radiotherapy,” the authors wrote. “ This classifier is an important step towards molecularly-stratified targeting of the use of radiotherapy.”

SOURCE:

The study, led by Per Karlsson, MD, PhD, University of Gothenburg, Sweden, was published online in the Journal of the National Cancer Institute.

LIMITATIONS:

One cohort (SweBCG) had limited use of adjuvant systemic therapy, which could affect generalizability. Additionally, low numbers of patients with low POLAR scores in two trials could affect the observed benefit of radiotherapy.

DISCLOSURES:

This study was supported by the Breast Cancer Institute Fund (Edinburgh and Lothians Health Foundation), Canadian Institutes of Health Research, Exact Sciences Corporation, PFS Genomics, Swedish Cancer Society, and Swedish Research Council. One author reported being an employee and owning stock or stock options or patents with Exact Sciences. Several authors reported having various ties with various sources including Exact Sciences.

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.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Fri, 11/22/2024 - 12:18
Un-Gate On Date
Fri, 11/22/2024 - 12:18
Use ProPublica
CFC Schedule Remove Status
Fri, 11/22/2024 - 12:18
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Fri, 11/22/2024 - 12:18

To Hold or Not to Hold GLP-1s Before Surgery

Article Type
Changed
Wed, 11/27/2024 - 03:25

This transcript has been edited for clarity. 

Recently, there have been two somewhat conflicting recommendations about how to deal with our patients who are on incretin hormone therapy before undergoing elective surgical procedures. 

First, the FDA [Food and Drug Administration] has updated the package inserts for all of these incretins, meaning the glucagon-like peptide-1 (GLP-1) receptor agonists and the dual glucose-dependent insulinotropic (GIP)/GLP-1 receptor agonist tirzepatide, with a warning about pulmonary aspiration during general anesthesia or deep sedation. They instruct patients to let healthcare providers know of any planned surgeries or procedures. This has come about because of postmarketing experience in which patients who are on GLP-1 receptor agonists have had residual gastric contents found despite reported adherence to preoperative fasting recommendations.

The problem with this is that the FDA says they don’t really actually know what to tell us to do or not to do because we don’t have knowledge as to how to truly mitigate the risk for pulmonary aspiration during general anesthesia or deep sedation. They don’t know if modifying preoperative fasting recommendations should be changed or if temporary discontinuation of the drugs could reduce this problem. They really don’t know what to tell us to do except to tell us that this is a problem we should discuss with our patients. 

At about the same time, a society guideline— and this was from a number of different societies, including the American Society of Anesthesiologists — stated that most patients should continue taking their GLP-1 receptor agonist before elective surgery.

This struck me as somewhat discordant from what the FDA said, although the FDA also says they don’t know quite what to tell us to do. This clinical guideline goes into a bit more detail, and what they think might be a good idea is that patients who are at the highest risk for GI side effects should follow a liquid diet for 24 hours before the procedure.

They basically look at who is at highest risk, and they say the following: Patients in the escalation phase of their incretin therapy — that is, early in treatment when the dose is increasing — are most likely to have delays in gastric emptying because that effect is lessened over time. They say that the elective surgery should be deferred until the escalation phase has passed and the GI symptoms have dissipated.

They’re very clear that patients who have significant GI symptoms, including nausea, vomiting, abdominal pain, constipation, and shortness of breath, should wait until their symptoms have dissipated. 

They think this is something that would be good no matter what dose of drug these patients are on. They do say that you tend to see more issues with gastric emptying in patients at the highest dose of a GLP-1 receptor agonist. They also mention other medical conditions that may slow gastric emptying, such as Parkinson’s disease, which may further modify the perioperative management plan. 

Their proposed solutions that sort of correspond with my proposed solutions include assessing the patient. Obviously, if a patient is going up on the dose of these drugs or having many GI side effects, that’s someone who you probably don’t want to send for elective surgery if you don’t have to. However, if you need to — and possibly in everybody — you might want to withhold the drug for 10-14 days preoperatively to make sure they don’t have significant GI side effects as they’re preparing for their procedure.

One of the things the anesthesiology group was worried about was that glucose levels would go up and patients would have hyperglycemia going into surgery. I’m not so worried about holding a dose or two of one of these agents. I don’t see much hyperglycemia occurring. If it does, you can treat it in other ways. 

If it’s somebody where you think they’re having symptoms but they want to have the procedure anyway, you can put them on a liquid diet for 24 hours or so, so that there’s less of a risk for retained gastric contents, at least solid gastric contents. Anesthesiologists can help with this as well because in many cases, they can do a point-of-care gastric ultrasound to check for retained food or fluid. 

I know this is sort of vague because I don’t have clear recommendations, but I do think it’s important to talk with your patients to assess whether they’re having signs or symptoms of gastroparesis. I think it’s not unreasonable to hold the incretin hormone therapy for one or two doses before a procedure if you have that opportunity, and be sure that the anesthesiologist and surgery team are aware of the fact that the patient has been on one of these agents so that they’re a little more aware of the risk for aspiration.

Anne L. Peters, Professor, Department of Clinical Medicine, Keck School of Medicine; Director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles, California, has disclosed the following relevant financial relationships: Serve(d) on the advisory board for Abbott Diabetes Care; Becton Dickinson; Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company; Lexicon Pharmaceuticals, Inc.; Livongo; Medscape; Merck & Co., Inc.; Novo Nordisk; Omada Health; OptumHealth; sanofi; Zafgen Received research support from: Dexcom; MannKind Corporation; Astra Zeneca. Serve(d) as a member of a speakers bureau for: Novo Nordisk.

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

Publications
Topics
Sections

This transcript has been edited for clarity. 

Recently, there have been two somewhat conflicting recommendations about how to deal with our patients who are on incretin hormone therapy before undergoing elective surgical procedures. 

First, the FDA [Food and Drug Administration] has updated the package inserts for all of these incretins, meaning the glucagon-like peptide-1 (GLP-1) receptor agonists and the dual glucose-dependent insulinotropic (GIP)/GLP-1 receptor agonist tirzepatide, with a warning about pulmonary aspiration during general anesthesia or deep sedation. They instruct patients to let healthcare providers know of any planned surgeries or procedures. This has come about because of postmarketing experience in which patients who are on GLP-1 receptor agonists have had residual gastric contents found despite reported adherence to preoperative fasting recommendations.

The problem with this is that the FDA says they don’t really actually know what to tell us to do or not to do because we don’t have knowledge as to how to truly mitigate the risk for pulmonary aspiration during general anesthesia or deep sedation. They don’t know if modifying preoperative fasting recommendations should be changed or if temporary discontinuation of the drugs could reduce this problem. They really don’t know what to tell us to do except to tell us that this is a problem we should discuss with our patients. 

At about the same time, a society guideline— and this was from a number of different societies, including the American Society of Anesthesiologists — stated that most patients should continue taking their GLP-1 receptor agonist before elective surgery.

This struck me as somewhat discordant from what the FDA said, although the FDA also says they don’t know quite what to tell us to do. This clinical guideline goes into a bit more detail, and what they think might be a good idea is that patients who are at the highest risk for GI side effects should follow a liquid diet for 24 hours before the procedure.

They basically look at who is at highest risk, and they say the following: Patients in the escalation phase of their incretin therapy — that is, early in treatment when the dose is increasing — are most likely to have delays in gastric emptying because that effect is lessened over time. They say that the elective surgery should be deferred until the escalation phase has passed and the GI symptoms have dissipated.

They’re very clear that patients who have significant GI symptoms, including nausea, vomiting, abdominal pain, constipation, and shortness of breath, should wait until their symptoms have dissipated. 

They think this is something that would be good no matter what dose of drug these patients are on. They do say that you tend to see more issues with gastric emptying in patients at the highest dose of a GLP-1 receptor agonist. They also mention other medical conditions that may slow gastric emptying, such as Parkinson’s disease, which may further modify the perioperative management plan. 

Their proposed solutions that sort of correspond with my proposed solutions include assessing the patient. Obviously, if a patient is going up on the dose of these drugs or having many GI side effects, that’s someone who you probably don’t want to send for elective surgery if you don’t have to. However, if you need to — and possibly in everybody — you might want to withhold the drug for 10-14 days preoperatively to make sure they don’t have significant GI side effects as they’re preparing for their procedure.

One of the things the anesthesiology group was worried about was that glucose levels would go up and patients would have hyperglycemia going into surgery. I’m not so worried about holding a dose or two of one of these agents. I don’t see much hyperglycemia occurring. If it does, you can treat it in other ways. 

If it’s somebody where you think they’re having symptoms but they want to have the procedure anyway, you can put them on a liquid diet for 24 hours or so, so that there’s less of a risk for retained gastric contents, at least solid gastric contents. Anesthesiologists can help with this as well because in many cases, they can do a point-of-care gastric ultrasound to check for retained food or fluid. 

I know this is sort of vague because I don’t have clear recommendations, but I do think it’s important to talk with your patients to assess whether they’re having signs or symptoms of gastroparesis. I think it’s not unreasonable to hold the incretin hormone therapy for one or two doses before a procedure if you have that opportunity, and be sure that the anesthesiologist and surgery team are aware of the fact that the patient has been on one of these agents so that they’re a little more aware of the risk for aspiration.

Anne L. Peters, Professor, Department of Clinical Medicine, Keck School of Medicine; Director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles, California, has disclosed the following relevant financial relationships: Serve(d) on the advisory board for Abbott Diabetes Care; Becton Dickinson; Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company; Lexicon Pharmaceuticals, Inc.; Livongo; Medscape; Merck & Co., Inc.; Novo Nordisk; Omada Health; OptumHealth; sanofi; Zafgen Received research support from: Dexcom; MannKind Corporation; Astra Zeneca. Serve(d) as a member of a speakers bureau for: Novo Nordisk.

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

This transcript has been edited for clarity. 

Recently, there have been two somewhat conflicting recommendations about how to deal with our patients who are on incretin hormone therapy before undergoing elective surgical procedures. 

First, the FDA [Food and Drug Administration] has updated the package inserts for all of these incretins, meaning the glucagon-like peptide-1 (GLP-1) receptor agonists and the dual glucose-dependent insulinotropic (GIP)/GLP-1 receptor agonist tirzepatide, with a warning about pulmonary aspiration during general anesthesia or deep sedation. They instruct patients to let healthcare providers know of any planned surgeries or procedures. This has come about because of postmarketing experience in which patients who are on GLP-1 receptor agonists have had residual gastric contents found despite reported adherence to preoperative fasting recommendations.

The problem with this is that the FDA says they don’t really actually know what to tell us to do or not to do because we don’t have knowledge as to how to truly mitigate the risk for pulmonary aspiration during general anesthesia or deep sedation. They don’t know if modifying preoperative fasting recommendations should be changed or if temporary discontinuation of the drugs could reduce this problem. They really don’t know what to tell us to do except to tell us that this is a problem we should discuss with our patients. 

At about the same time, a society guideline— and this was from a number of different societies, including the American Society of Anesthesiologists — stated that most patients should continue taking their GLP-1 receptor agonist before elective surgery.

This struck me as somewhat discordant from what the FDA said, although the FDA also says they don’t know quite what to tell us to do. This clinical guideline goes into a bit more detail, and what they think might be a good idea is that patients who are at the highest risk for GI side effects should follow a liquid diet for 24 hours before the procedure.

They basically look at who is at highest risk, and they say the following: Patients in the escalation phase of their incretin therapy — that is, early in treatment when the dose is increasing — are most likely to have delays in gastric emptying because that effect is lessened over time. They say that the elective surgery should be deferred until the escalation phase has passed and the GI symptoms have dissipated.

They’re very clear that patients who have significant GI symptoms, including nausea, vomiting, abdominal pain, constipation, and shortness of breath, should wait until their symptoms have dissipated. 

They think this is something that would be good no matter what dose of drug these patients are on. They do say that you tend to see more issues with gastric emptying in patients at the highest dose of a GLP-1 receptor agonist. They also mention other medical conditions that may slow gastric emptying, such as Parkinson’s disease, which may further modify the perioperative management plan. 

Their proposed solutions that sort of correspond with my proposed solutions include assessing the patient. Obviously, if a patient is going up on the dose of these drugs or having many GI side effects, that’s someone who you probably don’t want to send for elective surgery if you don’t have to. However, if you need to — and possibly in everybody — you might want to withhold the drug for 10-14 days preoperatively to make sure they don’t have significant GI side effects as they’re preparing for their procedure.

One of the things the anesthesiology group was worried about was that glucose levels would go up and patients would have hyperglycemia going into surgery. I’m not so worried about holding a dose or two of one of these agents. I don’t see much hyperglycemia occurring. If it does, you can treat it in other ways. 

If it’s somebody where you think they’re having symptoms but they want to have the procedure anyway, you can put them on a liquid diet for 24 hours or so, so that there’s less of a risk for retained gastric contents, at least solid gastric contents. Anesthesiologists can help with this as well because in many cases, they can do a point-of-care gastric ultrasound to check for retained food or fluid. 

I know this is sort of vague because I don’t have clear recommendations, but I do think it’s important to talk with your patients to assess whether they’re having signs or symptoms of gastroparesis. I think it’s not unreasonable to hold the incretin hormone therapy for one or two doses before a procedure if you have that opportunity, and be sure that the anesthesiologist and surgery team are aware of the fact that the patient has been on one of these agents so that they’re a little more aware of the risk for aspiration.

Anne L. Peters, Professor, Department of Clinical Medicine, Keck School of Medicine; Director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles, California, has disclosed the following relevant financial relationships: Serve(d) on the advisory board for Abbott Diabetes Care; Becton Dickinson; Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company; Lexicon Pharmaceuticals, Inc.; Livongo; Medscape; Merck & Co., Inc.; Novo Nordisk; Omada Health; OptumHealth; sanofi; Zafgen Received research support from: Dexcom; MannKind Corporation; Astra Zeneca. Serve(d) as a member of a speakers bureau for: Novo Nordisk.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Thu, 11/21/2024 - 15:32
Un-Gate On Date
Thu, 11/21/2024 - 15:32
Use ProPublica
CFC Schedule Remove Status
Thu, 11/21/2024 - 15:32
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Thu, 11/21/2024 - 15:32

Lessons Learned: What Docs Wish Med Students Knew

Article Type
Changed
Wed, 11/27/2024 - 04:17

Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.

Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.

“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.

We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead. 

 

You Won’t Know Everything, and That’s Okay

When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.

“No one expects you to know it all,” she explained. “What’s important is to cultivate curiosity and a willingness to ask for help when needed.” 

David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”

Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.

 

You’ll Take Your Work Home With You

Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan. 

“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”

When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”

Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home. 

“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”

 

Burnout Is Real — Make Self-Care a Priority 

As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said. 

The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”

That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”

 

Avoid Relying Too Heavily on Tech

Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”

It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.

“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.

 

Partner With Your Patients, Even When It’s Difficult

Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.

“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”

Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”

Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”

At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.

“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”

 

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

Publications
Topics
Sections

Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.

Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.

“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.

We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead. 

 

You Won’t Know Everything, and That’s Okay

When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.

“No one expects you to know it all,” she explained. “What’s important is to cultivate curiosity and a willingness to ask for help when needed.” 

David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”

Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.

 

You’ll Take Your Work Home With You

Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan. 

“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”

When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”

Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home. 

“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”

 

Burnout Is Real — Make Self-Care a Priority 

As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said. 

The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”

That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”

 

Avoid Relying Too Heavily on Tech

Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”

It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.

“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.

 

Partner With Your Patients, Even When It’s Difficult

Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.

“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”

Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”

Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”

At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.

“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”

 

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

Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.

Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.

“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.

We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead. 

 

You Won’t Know Everything, and That’s Okay

When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.

“No one expects you to know it all,” she explained. “What’s important is to cultivate curiosity and a willingness to ask for help when needed.” 

David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”

Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.

 

You’ll Take Your Work Home With You

Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan. 

“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”

When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”

Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home. 

“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”

 

Burnout Is Real — Make Self-Care a Priority 

As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said. 

The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”

That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”

 

Avoid Relying Too Heavily on Tech

Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”

It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.

“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.

 

Partner With Your Patients, Even When It’s Difficult

Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.

“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”

Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”

Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”

At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.

“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”

 

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Tue, 11/19/2024 - 13:07
Un-Gate On Date
Tue, 11/19/2024 - 13:07
Use ProPublica
CFC Schedule Remove Status
Tue, 11/19/2024 - 13:07
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Tue, 11/19/2024 - 13:07

Prostate Cancer: Has Active Surveillance Solved the Problem of Overtreatment?

Article Type
Changed
Wed, 11/27/2024 - 04:09

Overtreatment of men with prostate cancer and limited life expectancy (LE) has persisted in the era of active surveillance and worsened in some instances, according to a new study.

“Overtreatment of men with limited longevity for intermediate- and high-risk tumors has not only failed to improve but has actually worsened over the last 20 years,” Timothy Daskivich, MD, MSHPM, with Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Many doctors assume that the increase in uptake of active surveillance for low-risk prostate cancers has solved the problem of overtreatment, but this trend has not affected overtreatment of men with low likelihood of living long enough to benefit from treatment who have higher-risk tumors,” Daskivich said.

The study was published online on November 11 in JAMA Internal Medicine.

‘Concerning’ Real-World Data

For men with low- and intermediate-risk prostate cancer expected to live fewer than 10 years, prostate cancer screening and aggressive treatment are not recommended.

Daskivich and colleagues analyzed data on 243,928 men (mean age, 66 years) in the Veterans Affairs (VA) Health System with clinically localized prostate cancer diagnosed between 2000 and 2019.

About 21% had LE < 10 years, and about 4% had LE < 5 years, according to the validated age-adjusted Prostate Cancer Comorbidity Index.

Overtreatment was defined as aggressive treatment (surgery or radiation) in those with LE < 10 years and low- to intermediate-risk disease and in those with LE < 5 years and high-risk disease, in line with current guidelines.

Among men with LE < 10 years, the proportion of men overtreated with surgery or radiotherapy for low-risk disease decreased 22% but increased 22% for intermediate-risk disease during the study period.

Among men with LE < 5 years, the proportion of men treated with definitive treatment for high-risk disease increased 29%.

“While lower-risk tumors are treated less aggressively across the board, including in men with limited longevity, it seems that we are more indiscriminately treating men with higher-risk disease without considering their expected longevity,” Daskivich said in an interview.

 

Is This Happening in the General US Population?

Daskivich noted that the sample included a large sample of men diagnosed with localized prostate cancer in the VA Health System.

“Rates of overtreatment are likely to be lower in the VA [Health System], so the problem may be worse in the community setting. The VA [Health System] has been exemplary in its uptake of active surveillance for low-risk cancers, leading the effort to reduce overtreatment of men with low-risk cancers. However, the problem of overtreatment of men with limited longevity persists in the VA [Health System], underscoring the pervasiveness of this problem,” he explained.

“We don’t have a perfect head-to-head comparison of overtreatment in the VA setting vs in the community. [However, one study shows] that this is not a VA-specific phenomenon and that there is an increase in overtreatment of men with limited longevity in a Medicare population as well,” Daskivich noted.

 

Is Overtreatment All Bad?

Overtreatment of prostate cancer, especially in cases where the cancer is unlikely to progress or cause symptoms, can lead to significant physical, psychological, and financial harms, Christopher Anderson, MD, urologist with Columbia University Irving Medical Center in New York City, who wasn’t involved in the study, noted in an interview.

In the study by Daskivich and colleagues, over three quarters of the overtreatment was radiation therapy, which carries the risk for urinary, bowel, and sexual issues.

“Overscreening, which can lead to overtreatment, is a core issue,” Anderson said. It’s easy to order a “simple” prostate-specific antigen blood test, but in an older man with limited LE, that can lead to a host of further testing, he said.

Stopping the pipeline of overscreening that then feeds into the cascade of overtreatment is the first step in addressing the problem of prostate cancer overtreatment, Nancy Li Schoenborn, MD, MHS, with Johns Hopkins University School of Medicine, Baltimore, and Louise C. Walter, MD, with University of California San Francisco, wrote in an editorial in JAMA Internal Medicine.

Considering LE during screening decision-making is “fundamental to reducing harms of prostate cancer overdiagnosis and overtreatment” because limited LE increases the likelihood of experiencing “harms all along the diagnostic and treatment cascade following screening,” the editorial writers said.

The time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited LE distracts from monitoring and treating chronic symptomatic life-limiting illnesses, they noted.

 

Tough to Talk About?

Anderson noted that, in general, doctors are not great at estimating and counseling patients on LE. “It’s sometimes difficult to have that conversation,” he said.

Daskivich said physicians may fail to include average LE when advising patients on treatments because they believe that the patients do not want to discuss this topic. “Yet, in interviews with patients, we found that prostate cancer patients reported they wanted this information,” he continued, in an interview.

Solving the problem of overscreening and overtreatment will require a “multifaceted approach, including improving access to life expectancy data at the point of care for providers, educating providers on how to communicate this information, and improving data sources to predict longevity,” Daskivich said.

He said it’s equally important to note that some men with prostate cancer may choose treatment even if they have a limited longevity.

“Not all patients will choose conservative management, even if it is recommended by guidelines. However, they need to be given the opportunity to make a good decision for themselves with the best possible data,” Daskivich said.

This work was supported in part by a US Department of VA Merit Review. Daskivich reported receiving personal fees from the Medical Education Speakers Network, EDAP, and RAND; research support from Lantheus and Janssen; and a patent pending for a system for healthcare visit quality assessment outside the submitted work. Schoenborn, Walter, and Anderson had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

Overtreatment of men with prostate cancer and limited life expectancy (LE) has persisted in the era of active surveillance and worsened in some instances, according to a new study.

“Overtreatment of men with limited longevity for intermediate- and high-risk tumors has not only failed to improve but has actually worsened over the last 20 years,” Timothy Daskivich, MD, MSHPM, with Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Many doctors assume that the increase in uptake of active surveillance for low-risk prostate cancers has solved the problem of overtreatment, but this trend has not affected overtreatment of men with low likelihood of living long enough to benefit from treatment who have higher-risk tumors,” Daskivich said.

The study was published online on November 11 in JAMA Internal Medicine.

‘Concerning’ Real-World Data

For men with low- and intermediate-risk prostate cancer expected to live fewer than 10 years, prostate cancer screening and aggressive treatment are not recommended.

Daskivich and colleagues analyzed data on 243,928 men (mean age, 66 years) in the Veterans Affairs (VA) Health System with clinically localized prostate cancer diagnosed between 2000 and 2019.

About 21% had LE < 10 years, and about 4% had LE < 5 years, according to the validated age-adjusted Prostate Cancer Comorbidity Index.

Overtreatment was defined as aggressive treatment (surgery or radiation) in those with LE < 10 years and low- to intermediate-risk disease and in those with LE < 5 years and high-risk disease, in line with current guidelines.

Among men with LE < 10 years, the proportion of men overtreated with surgery or radiotherapy for low-risk disease decreased 22% but increased 22% for intermediate-risk disease during the study period.

Among men with LE < 5 years, the proportion of men treated with definitive treatment for high-risk disease increased 29%.

“While lower-risk tumors are treated less aggressively across the board, including in men with limited longevity, it seems that we are more indiscriminately treating men with higher-risk disease without considering their expected longevity,” Daskivich said in an interview.

 

Is This Happening in the General US Population?

Daskivich noted that the sample included a large sample of men diagnosed with localized prostate cancer in the VA Health System.

“Rates of overtreatment are likely to be lower in the VA [Health System], so the problem may be worse in the community setting. The VA [Health System] has been exemplary in its uptake of active surveillance for low-risk cancers, leading the effort to reduce overtreatment of men with low-risk cancers. However, the problem of overtreatment of men with limited longevity persists in the VA [Health System], underscoring the pervasiveness of this problem,” he explained.

“We don’t have a perfect head-to-head comparison of overtreatment in the VA setting vs in the community. [However, one study shows] that this is not a VA-specific phenomenon and that there is an increase in overtreatment of men with limited longevity in a Medicare population as well,” Daskivich noted.

 

Is Overtreatment All Bad?

Overtreatment of prostate cancer, especially in cases where the cancer is unlikely to progress or cause symptoms, can lead to significant physical, psychological, and financial harms, Christopher Anderson, MD, urologist with Columbia University Irving Medical Center in New York City, who wasn’t involved in the study, noted in an interview.

In the study by Daskivich and colleagues, over three quarters of the overtreatment was radiation therapy, which carries the risk for urinary, bowel, and sexual issues.

“Overscreening, which can lead to overtreatment, is a core issue,” Anderson said. It’s easy to order a “simple” prostate-specific antigen blood test, but in an older man with limited LE, that can lead to a host of further testing, he said.

Stopping the pipeline of overscreening that then feeds into the cascade of overtreatment is the first step in addressing the problem of prostate cancer overtreatment, Nancy Li Schoenborn, MD, MHS, with Johns Hopkins University School of Medicine, Baltimore, and Louise C. Walter, MD, with University of California San Francisco, wrote in an editorial in JAMA Internal Medicine.

Considering LE during screening decision-making is “fundamental to reducing harms of prostate cancer overdiagnosis and overtreatment” because limited LE increases the likelihood of experiencing “harms all along the diagnostic and treatment cascade following screening,” the editorial writers said.

The time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited LE distracts from monitoring and treating chronic symptomatic life-limiting illnesses, they noted.

 

Tough to Talk About?

Anderson noted that, in general, doctors are not great at estimating and counseling patients on LE. “It’s sometimes difficult to have that conversation,” he said.

Daskivich said physicians may fail to include average LE when advising patients on treatments because they believe that the patients do not want to discuss this topic. “Yet, in interviews with patients, we found that prostate cancer patients reported they wanted this information,” he continued, in an interview.

Solving the problem of overscreening and overtreatment will require a “multifaceted approach, including improving access to life expectancy data at the point of care for providers, educating providers on how to communicate this information, and improving data sources to predict longevity,” Daskivich said.

He said it’s equally important to note that some men with prostate cancer may choose treatment even if they have a limited longevity.

“Not all patients will choose conservative management, even if it is recommended by guidelines. However, they need to be given the opportunity to make a good decision for themselves with the best possible data,” Daskivich said.

This work was supported in part by a US Department of VA Merit Review. Daskivich reported receiving personal fees from the Medical Education Speakers Network, EDAP, and RAND; research support from Lantheus and Janssen; and a patent pending for a system for healthcare visit quality assessment outside the submitted work. Schoenborn, Walter, and Anderson had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

Overtreatment of men with prostate cancer and limited life expectancy (LE) has persisted in the era of active surveillance and worsened in some instances, according to a new study.

“Overtreatment of men with limited longevity for intermediate- and high-risk tumors has not only failed to improve but has actually worsened over the last 20 years,” Timothy Daskivich, MD, MSHPM, with Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Many doctors assume that the increase in uptake of active surveillance for low-risk prostate cancers has solved the problem of overtreatment, but this trend has not affected overtreatment of men with low likelihood of living long enough to benefit from treatment who have higher-risk tumors,” Daskivich said.

The study was published online on November 11 in JAMA Internal Medicine.

‘Concerning’ Real-World Data

For men with low- and intermediate-risk prostate cancer expected to live fewer than 10 years, prostate cancer screening and aggressive treatment are not recommended.

Daskivich and colleagues analyzed data on 243,928 men (mean age, 66 years) in the Veterans Affairs (VA) Health System with clinically localized prostate cancer diagnosed between 2000 and 2019.

About 21% had LE < 10 years, and about 4% had LE < 5 years, according to the validated age-adjusted Prostate Cancer Comorbidity Index.

Overtreatment was defined as aggressive treatment (surgery or radiation) in those with LE < 10 years and low- to intermediate-risk disease and in those with LE < 5 years and high-risk disease, in line with current guidelines.

Among men with LE < 10 years, the proportion of men overtreated with surgery or radiotherapy for low-risk disease decreased 22% but increased 22% for intermediate-risk disease during the study period.

Among men with LE < 5 years, the proportion of men treated with definitive treatment for high-risk disease increased 29%.

“While lower-risk tumors are treated less aggressively across the board, including in men with limited longevity, it seems that we are more indiscriminately treating men with higher-risk disease without considering their expected longevity,” Daskivich said in an interview.

 

Is This Happening in the General US Population?

Daskivich noted that the sample included a large sample of men diagnosed with localized prostate cancer in the VA Health System.

“Rates of overtreatment are likely to be lower in the VA [Health System], so the problem may be worse in the community setting. The VA [Health System] has been exemplary in its uptake of active surveillance for low-risk cancers, leading the effort to reduce overtreatment of men with low-risk cancers. However, the problem of overtreatment of men with limited longevity persists in the VA [Health System], underscoring the pervasiveness of this problem,” he explained.

“We don’t have a perfect head-to-head comparison of overtreatment in the VA setting vs in the community. [However, one study shows] that this is not a VA-specific phenomenon and that there is an increase in overtreatment of men with limited longevity in a Medicare population as well,” Daskivich noted.

 

Is Overtreatment All Bad?

Overtreatment of prostate cancer, especially in cases where the cancer is unlikely to progress or cause symptoms, can lead to significant physical, psychological, and financial harms, Christopher Anderson, MD, urologist with Columbia University Irving Medical Center in New York City, who wasn’t involved in the study, noted in an interview.

In the study by Daskivich and colleagues, over three quarters of the overtreatment was radiation therapy, which carries the risk for urinary, bowel, and sexual issues.

“Overscreening, which can lead to overtreatment, is a core issue,” Anderson said. It’s easy to order a “simple” prostate-specific antigen blood test, but in an older man with limited LE, that can lead to a host of further testing, he said.

Stopping the pipeline of overscreening that then feeds into the cascade of overtreatment is the first step in addressing the problem of prostate cancer overtreatment, Nancy Li Schoenborn, MD, MHS, with Johns Hopkins University School of Medicine, Baltimore, and Louise C. Walter, MD, with University of California San Francisco, wrote in an editorial in JAMA Internal Medicine.

Considering LE during screening decision-making is “fundamental to reducing harms of prostate cancer overdiagnosis and overtreatment” because limited LE increases the likelihood of experiencing “harms all along the diagnostic and treatment cascade following screening,” the editorial writers said.

The time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited LE distracts from monitoring and treating chronic symptomatic life-limiting illnesses, they noted.

 

Tough to Talk About?

Anderson noted that, in general, doctors are not great at estimating and counseling patients on LE. “It’s sometimes difficult to have that conversation,” he said.

Daskivich said physicians may fail to include average LE when advising patients on treatments because they believe that the patients do not want to discuss this topic. “Yet, in interviews with patients, we found that prostate cancer patients reported they wanted this information,” he continued, in an interview.

Solving the problem of overscreening and overtreatment will require a “multifaceted approach, including improving access to life expectancy data at the point of care for providers, educating providers on how to communicate this information, and improving data sources to predict longevity,” Daskivich said.

He said it’s equally important to note that some men with prostate cancer may choose treatment even if they have a limited longevity.

“Not all patients will choose conservative management, even if it is recommended by guidelines. However, they need to be given the opportunity to make a good decision for themselves with the best possible data,” Daskivich said.

This work was supported in part by a US Department of VA Merit Review. Daskivich reported receiving personal fees from the Medical Education Speakers Network, EDAP, and RAND; research support from Lantheus and Janssen; and a patent pending for a system for healthcare visit quality assessment outside the submitted work. Schoenborn, Walter, and Anderson had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Mon, 11/18/2024 - 14:13
Un-Gate On Date
Mon, 11/18/2024 - 14:13
Use ProPublica
CFC Schedule Remove Status
Mon, 11/18/2024 - 14:13
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Mon, 11/18/2024 - 14:13

Hemorrhoidal Disease Management: When and How to Intervene

Article Type
Changed
Wed, 11/27/2024 - 04:47

For patients with edematous hemorrhoidal thrombosis, the first line of treatment is a nonsteroidal anti-inflammatory drug (NSAID) such as ketoprofen, in conjunction with an analgesic, according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation at France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.

While patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.

 

No NSAIDs for Abscesses

In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.

The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.

 

Hygiene and Dietary Guidelines

Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:

  • Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
  • Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
  • Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
  • Grade 4: Prolapse is permanent.

In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.

 

Elastic Band Ligation

For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.

For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.

The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.

Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.

 

Advances in Minimally Invasive Surgery

Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.

Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.

While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.

Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.

Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”

 

Hemorrhoidal Embolization

Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.

The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.

Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”

Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.

This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.

Publications
Topics
Sections

For patients with edematous hemorrhoidal thrombosis, the first line of treatment is a nonsteroidal anti-inflammatory drug (NSAID) such as ketoprofen, in conjunction with an analgesic, according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation at France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.

While patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.

 

No NSAIDs for Abscesses

In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.

The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.

 

Hygiene and Dietary Guidelines

Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:

  • Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
  • Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
  • Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
  • Grade 4: Prolapse is permanent.

In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.

 

Elastic Band Ligation

For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.

For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.

The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.

Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.

 

Advances in Minimally Invasive Surgery

Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.

Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.

While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.

Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.

Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”

 

Hemorrhoidal Embolization

Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.

The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.

Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”

Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.

This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.

For patients with edematous hemorrhoidal thrombosis, the first line of treatment is a nonsteroidal anti-inflammatory drug (NSAID) such as ketoprofen, in conjunction with an analgesic, according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation at France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.

While patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.

 

No NSAIDs for Abscesses

In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.

The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.

 

Hygiene and Dietary Guidelines

Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:

  • Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
  • Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
  • Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
  • Grade 4: Prolapse is permanent.

In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.

 

Elastic Band Ligation

For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.

For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.

The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.

Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.

 

Advances in Minimally Invasive Surgery

Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.

Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.

While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.

Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.

Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”

 

Hemorrhoidal Embolization

Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.

The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.

Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”

Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.

This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 11/13/2024 - 15:06
Un-Gate On Date
Wed, 11/13/2024 - 15:06
Use ProPublica
CFC Schedule Remove Status
Wed, 11/13/2024 - 15:06
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Wed, 11/13/2024 - 15:06

How to Manage Patients on GLP-1s Before Surgery

Article Type
Changed
Wed, 11/27/2024 - 04:37

 

Guidance from professional societies on how to handle the risk for pulmonary aspiration during general anesthesia or deep sedation for patients taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs) continues to evolve, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.

The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.

Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”

Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.

The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.

But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:

Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”

“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”

“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”

“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”

“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”

Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”

“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”

Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.

“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”

Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”

“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”

Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”

“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”

Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
 

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

Publications
Topics
Sections

 

Guidance from professional societies on how to handle the risk for pulmonary aspiration during general anesthesia or deep sedation for patients taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs) continues to evolve, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.

The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.

Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”

Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.

The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.

But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:

Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”

“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”

“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”

“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”

“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”

Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”

“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”

Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.

“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”

Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”

“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”

Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”

“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”

Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
 

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

 

Guidance from professional societies on how to handle the risk for pulmonary aspiration during general anesthesia or deep sedation for patients taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs) continues to evolve, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.

The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.

Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”

Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.

The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.

But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:

Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”

“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”

“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”

“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”

“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”

Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”

“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”

Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.

“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”

Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”

“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”

Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”

“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”

Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
 

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 11/27/2024 - 04:37
Un-Gate On Date
Wed, 11/27/2024 - 04:37
Use ProPublica
CFC Schedule Remove Status
Wed, 11/27/2024 - 04:37
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Wed, 11/27/2024 - 04:37

Does Radiation Timing Affect QOL After Prostate Surgery?

Article Type
Changed
Wed, 11/27/2024 - 04:42

 

TOPLINE:

Receiving radiotherapy after prostatectomy does negatively affect long-term health-related quality of life, including sexual function, urinary incontinence, and urinary irritation, but the timing of radiation after prostatectomy — within a year or over a year from surgery — does not appear to significantly affect patients’ quality of life over the long term, a recent analysis finds.

METHODOLOGY:

  • Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
  • Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
  • Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
  • Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
  • The median follow-up duration was 85.6 months.

TAKEAWAY:

  • Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
  • Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
  • In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
  • Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.

IN PRACTICE:

“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”

 

 

SOURCE:

The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.

LIMITATIONS:

The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.

DISCLOSURES:

This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

TOPLINE:

Receiving radiotherapy after prostatectomy does negatively affect long-term health-related quality of life, including sexual function, urinary incontinence, and urinary irritation, but the timing of radiation after prostatectomy — within a year or over a year from surgery — does not appear to significantly affect patients’ quality of life over the long term, a recent analysis finds.

METHODOLOGY:

  • Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
  • Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
  • Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
  • Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
  • The median follow-up duration was 85.6 months.

TAKEAWAY:

  • Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
  • Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
  • In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
  • Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.

IN PRACTICE:

“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”

 

 

SOURCE:

The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.

LIMITATIONS:

The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.

DISCLOSURES:

This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Receiving radiotherapy after prostatectomy does negatively affect long-term health-related quality of life, including sexual function, urinary incontinence, and urinary irritation, but the timing of radiation after prostatectomy — within a year or over a year from surgery — does not appear to significantly affect patients’ quality of life over the long term, a recent analysis finds.

METHODOLOGY:

  • Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
  • Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
  • Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
  • Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
  • The median follow-up duration was 85.6 months.

TAKEAWAY:

  • Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
  • Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
  • In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
  • Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.

IN PRACTICE:

“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”

 

 

SOURCE:

The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.

LIMITATIONS:

The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.

DISCLOSURES:

This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 11/27/2024 - 04:42
Un-Gate On Date
Wed, 11/27/2024 - 04:42
Use ProPublica
CFC Schedule Remove Status
Wed, 11/27/2024 - 04:42
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Wed, 11/27/2024 - 04:42