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VIDEO: SHM seeks sites to test pediatric transition tool
Would you like to help the Society of Hospital Medicine translate its award-winning Project BOOST® Mentored Implementation Program into the pediatric setting?
“We’re hoping to get six sites to help us implement this project so we can collect data and see how well it works for pediatrics,” James O’Callaghan, MD, medical director, EvergreenHealth, Seattle Children’s, said in an interview.
In this video, recorded during HM17 , Dr. O’Callaghan describes how Pedi-BOOST is intended to work, and what types of pediatric transition concerns it is intended to address.
For more information, please visit the SHM website.
Dr. O’Callaghan had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Would you like to help the Society of Hospital Medicine translate its award-winning Project BOOST® Mentored Implementation Program into the pediatric setting?
“We’re hoping to get six sites to help us implement this project so we can collect data and see how well it works for pediatrics,” James O’Callaghan, MD, medical director, EvergreenHealth, Seattle Children’s, said in an interview.
In this video, recorded during HM17 , Dr. O’Callaghan describes how Pedi-BOOST is intended to work, and what types of pediatric transition concerns it is intended to address.
For more information, please visit the SHM website.
Dr. O’Callaghan had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Would you like to help the Society of Hospital Medicine translate its award-winning Project BOOST® Mentored Implementation Program into the pediatric setting?
“We’re hoping to get six sites to help us implement this project so we can collect data and see how well it works for pediatrics,” James O’Callaghan, MD, medical director, EvergreenHealth, Seattle Children’s, said in an interview.
In this video, recorded during HM17 , Dr. O’Callaghan describes how Pedi-BOOST is intended to work, and what types of pediatric transition concerns it is intended to address.
For more information, please visit the SHM website.
Dr. O’Callaghan had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Hospitalists can do better at end-of-life care, expert says
As a 99-year-old friend neared the end of her life, she offered a lesson for the health care world, said Deborah Korenstein, MD, chief of general internal medicine and director of clinical effectiveness at Memorial Sloan Kettering Cancer Center, N.Y., in the Tuesday session “Finding High Value Inpatient Care at the End of Life.”
The woman, nicknamed “Mitch,” had bluntly made her preference clear, Dr. Korenstein said: “She wanted to live independently as long as she could, and then, she wanted to be dead.”
But when a pathology report showed urothelial cancer, that preference didn’t stop an oncology urologist from suggesting that Mitch enter a clinical trial on an unproven therapy. Worse, Mitch initially said “yes” to this idea, seemingly because she thought that’s what she was expected to say.
It was only when Dr. Korenstein spoke with her that she changed her mind, entered inpatient hospice care, and died peacefully.
“I think it’s a cautionary tale about when a patient is crystal clear about their wishes,” she said. “The wave of the medical system kind of pushes them along in a particular direction that may go against their wishes.”
Dr. Korenstein said U.S. health care system does fairly well in some areas – for instance, research shows that about 60% of people die in their preferred location, whether at home or somewhere else. But it does not do so well in others – a 2013 Journal of General Internal Medicine study found that, during 2002-2008, Medicare beneficiaries typically spent $39,000 out of pocket on their medical care, and in 25% of cases, what they spent exceeded the total value of their assets.
As far as individual preferences, these tend to correlate poorly with the care that people actually get, Dr. Korenstein said. Patients often don’t express their wishes, doctors are poor judges of what matters to individual people, and care is largely driven by physician preferences and by the care setting involved, she said.
Given those problems, she said, “we cannot possibly be providing high-value individualized care.”
Hospitalists are well positioned to help patients’ preferences align with care, she added. Sometimes, a sustained relationship with a patient, while generally a positive thing, might lead a provider to become invested in their care in “ways that are not always rational.” So a hospitalist can have a helpful vantage point.
As a 99-year-old friend neared the end of her life, she offered a lesson for the health care world, said Deborah Korenstein, MD, chief of general internal medicine and director of clinical effectiveness at Memorial Sloan Kettering Cancer Center, N.Y., in the Tuesday session “Finding High Value Inpatient Care at the End of Life.”
The woman, nicknamed “Mitch,” had bluntly made her preference clear, Dr. Korenstein said: “She wanted to live independently as long as she could, and then, she wanted to be dead.”
But when a pathology report showed urothelial cancer, that preference didn’t stop an oncology urologist from suggesting that Mitch enter a clinical trial on an unproven therapy. Worse, Mitch initially said “yes” to this idea, seemingly because she thought that’s what she was expected to say.
It was only when Dr. Korenstein spoke with her that she changed her mind, entered inpatient hospice care, and died peacefully.
“I think it’s a cautionary tale about when a patient is crystal clear about their wishes,” she said. “The wave of the medical system kind of pushes them along in a particular direction that may go against their wishes.”
Dr. Korenstein said U.S. health care system does fairly well in some areas – for instance, research shows that about 60% of people die in their preferred location, whether at home or somewhere else. But it does not do so well in others – a 2013 Journal of General Internal Medicine study found that, during 2002-2008, Medicare beneficiaries typically spent $39,000 out of pocket on their medical care, and in 25% of cases, what they spent exceeded the total value of their assets.
As far as individual preferences, these tend to correlate poorly with the care that people actually get, Dr. Korenstein said. Patients often don’t express their wishes, doctors are poor judges of what matters to individual people, and care is largely driven by physician preferences and by the care setting involved, she said.
Given those problems, she said, “we cannot possibly be providing high-value individualized care.”
Hospitalists are well positioned to help patients’ preferences align with care, she added. Sometimes, a sustained relationship with a patient, while generally a positive thing, might lead a provider to become invested in their care in “ways that are not always rational.” So a hospitalist can have a helpful vantage point.
As a 99-year-old friend neared the end of her life, she offered a lesson for the health care world, said Deborah Korenstein, MD, chief of general internal medicine and director of clinical effectiveness at Memorial Sloan Kettering Cancer Center, N.Y., in the Tuesday session “Finding High Value Inpatient Care at the End of Life.”
The woman, nicknamed “Mitch,” had bluntly made her preference clear, Dr. Korenstein said: “She wanted to live independently as long as she could, and then, she wanted to be dead.”
But when a pathology report showed urothelial cancer, that preference didn’t stop an oncology urologist from suggesting that Mitch enter a clinical trial on an unproven therapy. Worse, Mitch initially said “yes” to this idea, seemingly because she thought that’s what she was expected to say.
It was only when Dr. Korenstein spoke with her that she changed her mind, entered inpatient hospice care, and died peacefully.
“I think it’s a cautionary tale about when a patient is crystal clear about their wishes,” she said. “The wave of the medical system kind of pushes them along in a particular direction that may go against their wishes.”
Dr. Korenstein said U.S. health care system does fairly well in some areas – for instance, research shows that about 60% of people die in their preferred location, whether at home or somewhere else. But it does not do so well in others – a 2013 Journal of General Internal Medicine study found that, during 2002-2008, Medicare beneficiaries typically spent $39,000 out of pocket on their medical care, and in 25% of cases, what they spent exceeded the total value of their assets.
As far as individual preferences, these tend to correlate poorly with the care that people actually get, Dr. Korenstein said. Patients often don’t express their wishes, doctors are poor judges of what matters to individual people, and care is largely driven by physician preferences and by the care setting involved, she said.
Given those problems, she said, “we cannot possibly be providing high-value individualized care.”
Hospitalists are well positioned to help patients’ preferences align with care, she added. Sometimes, a sustained relationship with a patient, while generally a positive thing, might lead a provider to become invested in their care in “ways that are not always rational.” So a hospitalist can have a helpful vantage point.
Filling the gap: Hospitalists & palliative care
Most Americans diagnosed with serious illness will be hospitalized in their last months. During these hospitalizations, hospitalists direct their care.
For seriously ill patients, consultation with palliative care specialists has been shown to promote patient- and family-centered care, ensuring that care is consistent with patients’ goals, values, and preferences. Yet, many hospitalized patients lack access to palliative care consultation, and specialists have identified key domains of primary palliative care that can be delivered by nonspecialists.
To fill this gap, SHM’s Center for Quality Improvement partnered with The Hastings Center, a world-renowned bioethics research institution, to develop a resource room focused on hospitalists’ role in providing high-quality communication about prognosis and goals of care. The resource room presents a Prognosis and Goals of Care Communication Pathway, which highlights key processes and maps them onto the daily workflows of hospitalist physicians.
The care pathway is grounded in palliative care communication research and the consensus guidance of The Hastings Center Guidelines for Decisions on Life-Sustaining Treatment and Care Near the End of Life. It was informed by a national stakeholder meeting of hospitalists, other hospital clinicians, patient and family advocates, bioethicists, social scientists, and other experts, who identified professional values of hospital medicine aligned with communication as part of good care for seriously ill patients.
A collaborative interdisciplinary work group convened by SHM and including hospitalists, palliative medicine physicians, a bioethicist, and a palliative nursing specialist constructed the care pathway in terms of key processes occurring at admission, during hospitalization, and in discharge planning to support primary palliative care integration into normal workflow. The resource room also includes skills-building tools and resources for individual hospitals, teams, and institutions.
The work group will present a workshop on the care pathway at Hospital Medicine 2017: “Demystifying Difficult Decisions: Strategies and Skills to Equip Hospitalists for High-Quality Goals of Care Conversations with Seriously Ill Patients and Their Families.” For more information on the resource room, visit www.hospitalmedicine.org/EOL.
Dr. Anderson is associate professor in residence in the division of hospital medicine at the University of California, San Francisco. She also serves as attending physician in the Palliative Care Program and codirector of the School of Nursing Interprofessional Palliative Care Training Program at UCSF.
Most Americans diagnosed with serious illness will be hospitalized in their last months. During these hospitalizations, hospitalists direct their care.
For seriously ill patients, consultation with palliative care specialists has been shown to promote patient- and family-centered care, ensuring that care is consistent with patients’ goals, values, and preferences. Yet, many hospitalized patients lack access to palliative care consultation, and specialists have identified key domains of primary palliative care that can be delivered by nonspecialists.
To fill this gap, SHM’s Center for Quality Improvement partnered with The Hastings Center, a world-renowned bioethics research institution, to develop a resource room focused on hospitalists’ role in providing high-quality communication about prognosis and goals of care. The resource room presents a Prognosis and Goals of Care Communication Pathway, which highlights key processes and maps them onto the daily workflows of hospitalist physicians.
The care pathway is grounded in palliative care communication research and the consensus guidance of The Hastings Center Guidelines for Decisions on Life-Sustaining Treatment and Care Near the End of Life. It was informed by a national stakeholder meeting of hospitalists, other hospital clinicians, patient and family advocates, bioethicists, social scientists, and other experts, who identified professional values of hospital medicine aligned with communication as part of good care for seriously ill patients.
A collaborative interdisciplinary work group convened by SHM and including hospitalists, palliative medicine physicians, a bioethicist, and a palliative nursing specialist constructed the care pathway in terms of key processes occurring at admission, during hospitalization, and in discharge planning to support primary palliative care integration into normal workflow. The resource room also includes skills-building tools and resources for individual hospitals, teams, and institutions.
The work group will present a workshop on the care pathway at Hospital Medicine 2017: “Demystifying Difficult Decisions: Strategies and Skills to Equip Hospitalists for High-Quality Goals of Care Conversations with Seriously Ill Patients and Their Families.” For more information on the resource room, visit www.hospitalmedicine.org/EOL.
Dr. Anderson is associate professor in residence in the division of hospital medicine at the University of California, San Francisco. She also serves as attending physician in the Palliative Care Program and codirector of the School of Nursing Interprofessional Palliative Care Training Program at UCSF.
Most Americans diagnosed with serious illness will be hospitalized in their last months. During these hospitalizations, hospitalists direct their care.
For seriously ill patients, consultation with palliative care specialists has been shown to promote patient- and family-centered care, ensuring that care is consistent with patients’ goals, values, and preferences. Yet, many hospitalized patients lack access to palliative care consultation, and specialists have identified key domains of primary palliative care that can be delivered by nonspecialists.
To fill this gap, SHM’s Center for Quality Improvement partnered with The Hastings Center, a world-renowned bioethics research institution, to develop a resource room focused on hospitalists’ role in providing high-quality communication about prognosis and goals of care. The resource room presents a Prognosis and Goals of Care Communication Pathway, which highlights key processes and maps them onto the daily workflows of hospitalist physicians.
The care pathway is grounded in palliative care communication research and the consensus guidance of The Hastings Center Guidelines for Decisions on Life-Sustaining Treatment and Care Near the End of Life. It was informed by a national stakeholder meeting of hospitalists, other hospital clinicians, patient and family advocates, bioethicists, social scientists, and other experts, who identified professional values of hospital medicine aligned with communication as part of good care for seriously ill patients.
A collaborative interdisciplinary work group convened by SHM and including hospitalists, palliative medicine physicians, a bioethicist, and a palliative nursing specialist constructed the care pathway in terms of key processes occurring at admission, during hospitalization, and in discharge planning to support primary palliative care integration into normal workflow. The resource room also includes skills-building tools and resources for individual hospitals, teams, and institutions.
The work group will present a workshop on the care pathway at Hospital Medicine 2017: “Demystifying Difficult Decisions: Strategies and Skills to Equip Hospitalists for High-Quality Goals of Care Conversations with Seriously Ill Patients and Their Families.” For more information on the resource room, visit www.hospitalmedicine.org/EOL.
Dr. Anderson is associate professor in residence in the division of hospital medicine at the University of California, San Francisco. She also serves as attending physician in the Palliative Care Program and codirector of the School of Nursing Interprofessional Palliative Care Training Program at UCSF.
Noncardiovascular comorbidities spike in acute heart failure
PARIS – Patients hospitalized for heart failure increasingly present with a growing number of noncardiovascular comorbidities, according to registry data from more than 300 U.S. hospitals.
During the decade of 2005-2014, the percentage of patients hospitalized for heart failure diagnosed with three or more noncardiovascular comorbidities (NCCs) jumped from abut 17% of these patients in 2005 to about 28% in 2015, Abhinav Sharma, MD, said at a meeting held by the Heart Failure Association of the ESC. This increase occurred as the percentages of hospitalized heart failure patients with none or one NCC showed clear decreases.
U.S. patients hospitalized for heart failure “appear to now be sicker and more medically complex. Probably, a large number of the noncardiovascular comorbidities are not being recognized when the focus is on treating the patient’s heart failure,” he said in an interview. “If we can identify the noncardiovascular comorbidities and target appropriate treatment, it may potentially decrease the risk of readmissions.”
He included five NCCs in his analysis: chronic obstructive pulmonary disease, anemia, diabetes, chronic kidney disease, and obesity.
His analysis showed that a higher rate of readmissions, as well as increased mortality both in hospital and during the 30 days following discharge, are outcomes that all connect with increased numbers of NCCs. Patients with three or more NCCs at the time of their heart failure admission were about 50% more likely to die in hospital, about 65% more likely to die during the 30 days following admission, about 35% more likely to be readmitted, and about half as likely to be discharged home following hospitalization, when compared with patients with no NCC in multivariate analyses that adjusted for demographic and other clinical variables. Patients with three or more NCCs were also about 67% more likely to have an index hospitalization of at least 4 days, compared with patients with no NCC.
Dr. Sharma speculated that the increased prevalence of multiple NCCs in acute heart failure patients may result, in part, from secular trends in the rates of diabetes and obesity and the noncardiovascular comorbidities associated with these conditions. All five of the NCCs included in his analysis showed increased prevalence rates from 2005 to 2014 in the patients he studied. The biggest jump occurred in the prevalence of chronic obstructive pulmonary disease, which rose from about 27% in 2005 to about 35% in 2014.
His study used data collected in the Get With the Guidelines–Heart Failure Registry, which began in 2005, and included just under 208,000 total patients. He acknowledged that it is hard to know how representative these patients are of the entire population of U.S. patients hospitalized for heart failure during the study period, because the patients he studied came from a self-selected group of more than 300 hospitals that opted to participate in the registry. “We need to see if this can be extrapolated to all U.S. hospitals,” Dr. Sharma said.
[email protected]
On Twitter @mitchelzoler
PARIS – Patients hospitalized for heart failure increasingly present with a growing number of noncardiovascular comorbidities, according to registry data from more than 300 U.S. hospitals.
During the decade of 2005-2014, the percentage of patients hospitalized for heart failure diagnosed with three or more noncardiovascular comorbidities (NCCs) jumped from abut 17% of these patients in 2005 to about 28% in 2015, Abhinav Sharma, MD, said at a meeting held by the Heart Failure Association of the ESC. This increase occurred as the percentages of hospitalized heart failure patients with none or one NCC showed clear decreases.
U.S. patients hospitalized for heart failure “appear to now be sicker and more medically complex. Probably, a large number of the noncardiovascular comorbidities are not being recognized when the focus is on treating the patient’s heart failure,” he said in an interview. “If we can identify the noncardiovascular comorbidities and target appropriate treatment, it may potentially decrease the risk of readmissions.”
He included five NCCs in his analysis: chronic obstructive pulmonary disease, anemia, diabetes, chronic kidney disease, and obesity.
His analysis showed that a higher rate of readmissions, as well as increased mortality both in hospital and during the 30 days following discharge, are outcomes that all connect with increased numbers of NCCs. Patients with three or more NCCs at the time of their heart failure admission were about 50% more likely to die in hospital, about 65% more likely to die during the 30 days following admission, about 35% more likely to be readmitted, and about half as likely to be discharged home following hospitalization, when compared with patients with no NCC in multivariate analyses that adjusted for demographic and other clinical variables. Patients with three or more NCCs were also about 67% more likely to have an index hospitalization of at least 4 days, compared with patients with no NCC.
Dr. Sharma speculated that the increased prevalence of multiple NCCs in acute heart failure patients may result, in part, from secular trends in the rates of diabetes and obesity and the noncardiovascular comorbidities associated with these conditions. All five of the NCCs included in his analysis showed increased prevalence rates from 2005 to 2014 in the patients he studied. The biggest jump occurred in the prevalence of chronic obstructive pulmonary disease, which rose from about 27% in 2005 to about 35% in 2014.
His study used data collected in the Get With the Guidelines–Heart Failure Registry, which began in 2005, and included just under 208,000 total patients. He acknowledged that it is hard to know how representative these patients are of the entire population of U.S. patients hospitalized for heart failure during the study period, because the patients he studied came from a self-selected group of more than 300 hospitals that opted to participate in the registry. “We need to see if this can be extrapolated to all U.S. hospitals,” Dr. Sharma said.
[email protected]
On Twitter @mitchelzoler
PARIS – Patients hospitalized for heart failure increasingly present with a growing number of noncardiovascular comorbidities, according to registry data from more than 300 U.S. hospitals.
During the decade of 2005-2014, the percentage of patients hospitalized for heart failure diagnosed with three or more noncardiovascular comorbidities (NCCs) jumped from abut 17% of these patients in 2005 to about 28% in 2015, Abhinav Sharma, MD, said at a meeting held by the Heart Failure Association of the ESC. This increase occurred as the percentages of hospitalized heart failure patients with none or one NCC showed clear decreases.
U.S. patients hospitalized for heart failure “appear to now be sicker and more medically complex. Probably, a large number of the noncardiovascular comorbidities are not being recognized when the focus is on treating the patient’s heart failure,” he said in an interview. “If we can identify the noncardiovascular comorbidities and target appropriate treatment, it may potentially decrease the risk of readmissions.”
He included five NCCs in his analysis: chronic obstructive pulmonary disease, anemia, diabetes, chronic kidney disease, and obesity.
His analysis showed that a higher rate of readmissions, as well as increased mortality both in hospital and during the 30 days following discharge, are outcomes that all connect with increased numbers of NCCs. Patients with three or more NCCs at the time of their heart failure admission were about 50% more likely to die in hospital, about 65% more likely to die during the 30 days following admission, about 35% more likely to be readmitted, and about half as likely to be discharged home following hospitalization, when compared with patients with no NCC in multivariate analyses that adjusted for demographic and other clinical variables. Patients with three or more NCCs were also about 67% more likely to have an index hospitalization of at least 4 days, compared with patients with no NCC.
Dr. Sharma speculated that the increased prevalence of multiple NCCs in acute heart failure patients may result, in part, from secular trends in the rates of diabetes and obesity and the noncardiovascular comorbidities associated with these conditions. All five of the NCCs included in his analysis showed increased prevalence rates from 2005 to 2014 in the patients he studied. The biggest jump occurred in the prevalence of chronic obstructive pulmonary disease, which rose from about 27% in 2005 to about 35% in 2014.
His study used data collected in the Get With the Guidelines–Heart Failure Registry, which began in 2005, and included just under 208,000 total patients. He acknowledged that it is hard to know how representative these patients are of the entire population of U.S. patients hospitalized for heart failure during the study period, because the patients he studied came from a self-selected group of more than 300 hospitals that opted to participate in the registry. “We need to see if this can be extrapolated to all U.S. hospitals,” Dr. Sharma said.
[email protected]
On Twitter @mitchelzoler
AT HEART FAILURE 2017
Key clinical point:
Major finding: The prevalence of three or more noncardiovascular comorbidities jumped from about 17% in 2005 to about 28% in 2014.
Data source: Review of 207,984 U.S. hospitalized heart failure patients included in the Get With the Guidelines–Heart Failure Registry during 2005-2014.
Disclosures: Dr. Sharma has received research support from Roche Diagnostics and Takeda.
Decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation
Clinical question: This work group synthesized available data to address whether and when anticoagulant therapy should be interrupted, whether and how anticoagulant bridging with a parenteral agent should be performed, and when and how anticoagulant therapy should be restarted for those who require temporary interruption.
Background: Atrial fibrillation is the most common sustained arrhythmia worldwide. Antithrombotic therapy, with a strong preference to oral anticoagulant (vitamin K antagonists [VKA] or Direct oral anticoagulant [DOAC]) over antiplatelet, is recommended for patients with high thrombotic risk. Temporary interruption is frequently necessary to mitigate bleed risk with surgical or invasive procedures. Although several factors go into the decision to interrupt anticoagulation, practice varies widely.
Study design: Data review and commentary.
Setting: Veterans’ Affairs Hospitals.
For the assessment of patient-related bleed risk, consider the HAS-BLED (Hypertension, Abnormal Renal and Liver Function, Stroke–Bleeding, Labile INRs, Elderly, Drugs or Alcohol) score: bleeding in the preceding 3 months, bleeding with a similar procedure or prior bridging, abnormalities of platelet function, concomitant use of antiplatelet therapy, and/or supratherapeutic international normalized ratio.
Vitamin K Antagonists:
- Do not interrupt for no clinically important or low bleed risk AND absence of patient-related bleed risk factor(s).
- Interrupt for procedures with intermediate or high bleed risk OR procedures with uncertain bleed risk and the presence of patient-related bleed risk factor(s).
- Consider interruption for procedure with no clinically important or low bleed risk AND the presence of patient-related bleed risk factor(s) OR procedures with uncertain bleed risk AND the absence of patient-related bleed risk factor(s).
Direct Oral Anticoagulants:
Can interrupt therapy for all bleed risks; duration based on creatinine clearance.
A procedure performed at the trough level may allow reinitiation the evening of or the day after the procedure with 1 or fewer dose(s) missed.
Bottom line: VKAs should be held based on surgical and patient bleed risk factors. Guidelines provide tools to calculate and consider. DOACs can always be held, preferably at trough times to minimize interruptions and for durations based on creatinine clearance.
Citation: Doherty JU, Gluckman TJ, Hucker WJ, et al. “2017 ACC Expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation.” J Am Coll Cardiol. 2017 Feb 21;69(7):871-98.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
Clinical question: This work group synthesized available data to address whether and when anticoagulant therapy should be interrupted, whether and how anticoagulant bridging with a parenteral agent should be performed, and when and how anticoagulant therapy should be restarted for those who require temporary interruption.
Background: Atrial fibrillation is the most common sustained arrhythmia worldwide. Antithrombotic therapy, with a strong preference to oral anticoagulant (vitamin K antagonists [VKA] or Direct oral anticoagulant [DOAC]) over antiplatelet, is recommended for patients with high thrombotic risk. Temporary interruption is frequently necessary to mitigate bleed risk with surgical or invasive procedures. Although several factors go into the decision to interrupt anticoagulation, practice varies widely.
Study design: Data review and commentary.
Setting: Veterans’ Affairs Hospitals.
For the assessment of patient-related bleed risk, consider the HAS-BLED (Hypertension, Abnormal Renal and Liver Function, Stroke–Bleeding, Labile INRs, Elderly, Drugs or Alcohol) score: bleeding in the preceding 3 months, bleeding with a similar procedure or prior bridging, abnormalities of platelet function, concomitant use of antiplatelet therapy, and/or supratherapeutic international normalized ratio.
Vitamin K Antagonists:
- Do not interrupt for no clinically important or low bleed risk AND absence of patient-related bleed risk factor(s).
- Interrupt for procedures with intermediate or high bleed risk OR procedures with uncertain bleed risk and the presence of patient-related bleed risk factor(s).
- Consider interruption for procedure with no clinically important or low bleed risk AND the presence of patient-related bleed risk factor(s) OR procedures with uncertain bleed risk AND the absence of patient-related bleed risk factor(s).
Direct Oral Anticoagulants:
Can interrupt therapy for all bleed risks; duration based on creatinine clearance.
A procedure performed at the trough level may allow reinitiation the evening of or the day after the procedure with 1 or fewer dose(s) missed.
Bottom line: VKAs should be held based on surgical and patient bleed risk factors. Guidelines provide tools to calculate and consider. DOACs can always be held, preferably at trough times to minimize interruptions and for durations based on creatinine clearance.
Citation: Doherty JU, Gluckman TJ, Hucker WJ, et al. “2017 ACC Expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation.” J Am Coll Cardiol. 2017 Feb 21;69(7):871-98.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
Clinical question: This work group synthesized available data to address whether and when anticoagulant therapy should be interrupted, whether and how anticoagulant bridging with a parenteral agent should be performed, and when and how anticoagulant therapy should be restarted for those who require temporary interruption.
Background: Atrial fibrillation is the most common sustained arrhythmia worldwide. Antithrombotic therapy, with a strong preference to oral anticoagulant (vitamin K antagonists [VKA] or Direct oral anticoagulant [DOAC]) over antiplatelet, is recommended for patients with high thrombotic risk. Temporary interruption is frequently necessary to mitigate bleed risk with surgical or invasive procedures. Although several factors go into the decision to interrupt anticoagulation, practice varies widely.
Study design: Data review and commentary.
Setting: Veterans’ Affairs Hospitals.
For the assessment of patient-related bleed risk, consider the HAS-BLED (Hypertension, Abnormal Renal and Liver Function, Stroke–Bleeding, Labile INRs, Elderly, Drugs or Alcohol) score: bleeding in the preceding 3 months, bleeding with a similar procedure or prior bridging, abnormalities of platelet function, concomitant use of antiplatelet therapy, and/or supratherapeutic international normalized ratio.
Vitamin K Antagonists:
- Do not interrupt for no clinically important or low bleed risk AND absence of patient-related bleed risk factor(s).
- Interrupt for procedures with intermediate or high bleed risk OR procedures with uncertain bleed risk and the presence of patient-related bleed risk factor(s).
- Consider interruption for procedure with no clinically important or low bleed risk AND the presence of patient-related bleed risk factor(s) OR procedures with uncertain bleed risk AND the absence of patient-related bleed risk factor(s).
Direct Oral Anticoagulants:
Can interrupt therapy for all bleed risks; duration based on creatinine clearance.
A procedure performed at the trough level may allow reinitiation the evening of or the day after the procedure with 1 or fewer dose(s) missed.
Bottom line: VKAs should be held based on surgical and patient bleed risk factors. Guidelines provide tools to calculate and consider. DOACs can always be held, preferably at trough times to minimize interruptions and for durations based on creatinine clearance.
Citation: Doherty JU, Gluckman TJ, Hucker WJ, et al. “2017 ACC Expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation.” J Am Coll Cardiol. 2017 Feb 21;69(7):871-98.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
Bezlotoxumab for prevention of recurrent Clostridium difficile infection
Clinical question: Does administration of monoclonal antibodies to C. difficile toxins A and B, in addition to standard-of-care antibiotics, prevent recurrent infection?
Background: Currently, no therapy has been approved to prevent recurrent C. difficile infection. A new approach to the prevention of recurrent C. difficile infection is the administration of monoclonal antibodies against C. difficile toxins (in addition to antibiotic therapy) as a form of passive immunity. Actoxumab and bezlotoxumab are fully human monoclonal antibodies that bind and neutralize C. difficile toxins A and B, respectively. In humans, the level of circulating antibodies against toxin A or toxin B has been correlated with protection against primary and recurrent C. difficile infection.
Study design: Two (MODIFY [MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection] I and MODIFY II) double-blind, randomized, placebo-controlled, phase III trials.
Setting: 322 sites (~68% inpatient) in 30 countries from Nov. 1, 2011, through May 22, 2015.
Synopsis: Trials pooled data from 2,174 adults who were receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infections. Participants received an infusion of either bezlotoxumab, actoxumab plus bezlotoxumab, or placebo for MODIFY II; actoxumab alone was also given in MODIFY I. The primary endpoint was recurrent infection within 12 weeks.
The rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% vs. 28%; 95% CI, −15.9 to −4.3; P less than .001; MODIFY II: 16% vs. 26%; 95% CI, −15.5 to −4.3; P less than .001) and was significantly lower with actoxumab plus bezlotoxumab than with placebo (MODIFY I: 16% vs. 28%; 95% CI, −17.4 to −5.9; P less than .001; MODIFY II: 15% vs. 26%; 95% CI, −16.4 to −5.1; P less than .001).
The serious adverse events were similar with most groups, the exception being actoxumab alone. Given the higher rate of recurrent infection and deaths in the actoxumab group from interim analysis, the enrollment was discontinued in MODIFY I.
Investigators did admit that safety assessments were limited because of the relatively small number of patients who received bezlotoxumab, making it difficult to detect potentially serious but low-frequency toxic effects.
Bottom line: In patients receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection, a single intravenous infusion of bezlotoxumab was associated with a significantly lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo.
Citation: Wilcox MH, Gerding DN, Poxton IR, et al. “Bezlotoxumab for prevention of recurrent Clostridium difficile infection.” N Engl J Med. 2017 Jan 26;376(4):305-17.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
Clinical question: Does administration of monoclonal antibodies to C. difficile toxins A and B, in addition to standard-of-care antibiotics, prevent recurrent infection?
Background: Currently, no therapy has been approved to prevent recurrent C. difficile infection. A new approach to the prevention of recurrent C. difficile infection is the administration of monoclonal antibodies against C. difficile toxins (in addition to antibiotic therapy) as a form of passive immunity. Actoxumab and bezlotoxumab are fully human monoclonal antibodies that bind and neutralize C. difficile toxins A and B, respectively. In humans, the level of circulating antibodies against toxin A or toxin B has been correlated with protection against primary and recurrent C. difficile infection.
Study design: Two (MODIFY [MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection] I and MODIFY II) double-blind, randomized, placebo-controlled, phase III trials.
Setting: 322 sites (~68% inpatient) in 30 countries from Nov. 1, 2011, through May 22, 2015.
Synopsis: Trials pooled data from 2,174 adults who were receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infections. Participants received an infusion of either bezlotoxumab, actoxumab plus bezlotoxumab, or placebo for MODIFY II; actoxumab alone was also given in MODIFY I. The primary endpoint was recurrent infection within 12 weeks.
The rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% vs. 28%; 95% CI, −15.9 to −4.3; P less than .001; MODIFY II: 16% vs. 26%; 95% CI, −15.5 to −4.3; P less than .001) and was significantly lower with actoxumab plus bezlotoxumab than with placebo (MODIFY I: 16% vs. 28%; 95% CI, −17.4 to −5.9; P less than .001; MODIFY II: 15% vs. 26%; 95% CI, −16.4 to −5.1; P less than .001).
The serious adverse events were similar with most groups, the exception being actoxumab alone. Given the higher rate of recurrent infection and deaths in the actoxumab group from interim analysis, the enrollment was discontinued in MODIFY I.
Investigators did admit that safety assessments were limited because of the relatively small number of patients who received bezlotoxumab, making it difficult to detect potentially serious but low-frequency toxic effects.
Bottom line: In patients receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection, a single intravenous infusion of bezlotoxumab was associated with a significantly lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo.
Citation: Wilcox MH, Gerding DN, Poxton IR, et al. “Bezlotoxumab for prevention of recurrent Clostridium difficile infection.” N Engl J Med. 2017 Jan 26;376(4):305-17.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
Clinical question: Does administration of monoclonal antibodies to C. difficile toxins A and B, in addition to standard-of-care antibiotics, prevent recurrent infection?
Background: Currently, no therapy has been approved to prevent recurrent C. difficile infection. A new approach to the prevention of recurrent C. difficile infection is the administration of monoclonal antibodies against C. difficile toxins (in addition to antibiotic therapy) as a form of passive immunity. Actoxumab and bezlotoxumab are fully human monoclonal antibodies that bind and neutralize C. difficile toxins A and B, respectively. In humans, the level of circulating antibodies against toxin A or toxin B has been correlated with protection against primary and recurrent C. difficile infection.
Study design: Two (MODIFY [MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection] I and MODIFY II) double-blind, randomized, placebo-controlled, phase III trials.
Setting: 322 sites (~68% inpatient) in 30 countries from Nov. 1, 2011, through May 22, 2015.
Synopsis: Trials pooled data from 2,174 adults who were receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infections. Participants received an infusion of either bezlotoxumab, actoxumab plus bezlotoxumab, or placebo for MODIFY II; actoxumab alone was also given in MODIFY I. The primary endpoint was recurrent infection within 12 weeks.
The rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% vs. 28%; 95% CI, −15.9 to −4.3; P less than .001; MODIFY II: 16% vs. 26%; 95% CI, −15.5 to −4.3; P less than .001) and was significantly lower with actoxumab plus bezlotoxumab than with placebo (MODIFY I: 16% vs. 28%; 95% CI, −17.4 to −5.9; P less than .001; MODIFY II: 15% vs. 26%; 95% CI, −16.4 to −5.1; P less than .001).
The serious adverse events were similar with most groups, the exception being actoxumab alone. Given the higher rate of recurrent infection and deaths in the actoxumab group from interim analysis, the enrollment was discontinued in MODIFY I.
Investigators did admit that safety assessments were limited because of the relatively small number of patients who received bezlotoxumab, making it difficult to detect potentially serious but low-frequency toxic effects.
Bottom line: In patients receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection, a single intravenous infusion of bezlotoxumab was associated with a significantly lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo.
Citation: Wilcox MH, Gerding DN, Poxton IR, et al. “Bezlotoxumab for prevention of recurrent Clostridium difficile infection.” N Engl J Med. 2017 Jan 26;376(4):305-17.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
What drives readmissions within 90 days after MI hospitalization
WASHINGTON – In a large population of Medicare patients hospitalized for acute MI, four factors stood out as predictors of increased likelihood of readmission within 90 days, Aaron D. Kugelmass, MD, reported at the annual meeting of the American College of Cardiology.
These four predictors of 90-day readmission were end-stage renal disease at the time of the initial admission for MI, which in a logistic regression model was independently associated with an 88% relative increase in readmission risk; no percutaneous coronary intervention (PCI) during the index hospitalization, which carried a 64% increase in risk; type 1 diabetes, with a 57% increased readmission rate; and heart failure at the initial hospitalization, with an associated 34% greater risk, according to Dr. Kugelmass, chief of cardiology and medical director of the heart and vascular center at Baystate Medical Center in Springfield, Mass.
“This is going to be a learning curve for everyone,” he said.
“The best way to deal with this change is to understand the factors driving costs and morbidity and mortality,” Dr. Kugelmass said, in explaining why he conducted a retrospective study of readmissions within 90 days in a population of 143,286 Medicare beneficiaries hospitalized for acute MI in 2014. The study focus was on readmissions because they add so much to total cost of care for a 90-day episode.
Twenty-eight percent of patients were readmitted at least once within 90 days of discharge following their acute MI. The Medicare bundled payment plan divides MI patients into two separate groups: those who undergo PCI during their initial hospitalization and those who receive medical management only. Thirty-one percent of the readmitted patients in Dr. Kugelmass’s study had undergone PCI during their index hospitalization, while the other 69% were managed medically.
Heart failure was the No. 1 reason for readmission within 90 days in patients who had PCI during the index hospitalization. It was the primary reason for 17.6% of readmissions. Next came recurrent angina or chest pain, which accounted for 6.6% of readmissions; chronic obstructive pulmonary disease or pneumonia, 6.3%; and GI bleeding with hemorrhage, which was the primary reason for 6.0% of readmissions. Together these four causes accounted for more than 36% of all readmissions in the PCI group.
“The GI bleeding data were really interesting,” the cardiologist said. “There’s a lot of talk now about reducing the duration of dual-antiplatelet therapy [DAPT] after PCI. This is an administrative data set that’s quite large, and it shows that GI bleeding in a post-PCI group early in the duration of DAPT is in fact a significant cause of readmission and poses significant hazard.”
Among patients who were medically managed during their index hospitalization, the top four reasons for readmission were heart failure, accounting for 20.6% of readmissions; cardiac surgery, 13.5%; sepsis, 7.8%; and chronic obstructive pulmonary disease/pneumonia, 6.3%. GI bleeding wasn’t a significant cause of readmission in this group.
“I think what we need to do next is dive deeper into the medically managed group. There is a cohort in there that’s incredibly sick and are likely to drive costs and be prone to readmission. And there’s another component of the medically managed group that had to be fairly healthy because they were able to undergo coronary artery bypass surgery within 90 days,” Dr. Kugelmass said.
He reported having no financial conflicts regarding his study.
WASHINGTON – In a large population of Medicare patients hospitalized for acute MI, four factors stood out as predictors of increased likelihood of readmission within 90 days, Aaron D. Kugelmass, MD, reported at the annual meeting of the American College of Cardiology.
These four predictors of 90-day readmission were end-stage renal disease at the time of the initial admission for MI, which in a logistic regression model was independently associated with an 88% relative increase in readmission risk; no percutaneous coronary intervention (PCI) during the index hospitalization, which carried a 64% increase in risk; type 1 diabetes, with a 57% increased readmission rate; and heart failure at the initial hospitalization, with an associated 34% greater risk, according to Dr. Kugelmass, chief of cardiology and medical director of the heart and vascular center at Baystate Medical Center in Springfield, Mass.
“This is going to be a learning curve for everyone,” he said.
“The best way to deal with this change is to understand the factors driving costs and morbidity and mortality,” Dr. Kugelmass said, in explaining why he conducted a retrospective study of readmissions within 90 days in a population of 143,286 Medicare beneficiaries hospitalized for acute MI in 2014. The study focus was on readmissions because they add so much to total cost of care for a 90-day episode.
Twenty-eight percent of patients were readmitted at least once within 90 days of discharge following their acute MI. The Medicare bundled payment plan divides MI patients into two separate groups: those who undergo PCI during their initial hospitalization and those who receive medical management only. Thirty-one percent of the readmitted patients in Dr. Kugelmass’s study had undergone PCI during their index hospitalization, while the other 69% were managed medically.
Heart failure was the No. 1 reason for readmission within 90 days in patients who had PCI during the index hospitalization. It was the primary reason for 17.6% of readmissions. Next came recurrent angina or chest pain, which accounted for 6.6% of readmissions; chronic obstructive pulmonary disease or pneumonia, 6.3%; and GI bleeding with hemorrhage, which was the primary reason for 6.0% of readmissions. Together these four causes accounted for more than 36% of all readmissions in the PCI group.
“The GI bleeding data were really interesting,” the cardiologist said. “There’s a lot of talk now about reducing the duration of dual-antiplatelet therapy [DAPT] after PCI. This is an administrative data set that’s quite large, and it shows that GI bleeding in a post-PCI group early in the duration of DAPT is in fact a significant cause of readmission and poses significant hazard.”
Among patients who were medically managed during their index hospitalization, the top four reasons for readmission were heart failure, accounting for 20.6% of readmissions; cardiac surgery, 13.5%; sepsis, 7.8%; and chronic obstructive pulmonary disease/pneumonia, 6.3%. GI bleeding wasn’t a significant cause of readmission in this group.
“I think what we need to do next is dive deeper into the medically managed group. There is a cohort in there that’s incredibly sick and are likely to drive costs and be prone to readmission. And there’s another component of the medically managed group that had to be fairly healthy because they were able to undergo coronary artery bypass surgery within 90 days,” Dr. Kugelmass said.
He reported having no financial conflicts regarding his study.
WASHINGTON – In a large population of Medicare patients hospitalized for acute MI, four factors stood out as predictors of increased likelihood of readmission within 90 days, Aaron D. Kugelmass, MD, reported at the annual meeting of the American College of Cardiology.
These four predictors of 90-day readmission were end-stage renal disease at the time of the initial admission for MI, which in a logistic regression model was independently associated with an 88% relative increase in readmission risk; no percutaneous coronary intervention (PCI) during the index hospitalization, which carried a 64% increase in risk; type 1 diabetes, with a 57% increased readmission rate; and heart failure at the initial hospitalization, with an associated 34% greater risk, according to Dr. Kugelmass, chief of cardiology and medical director of the heart and vascular center at Baystate Medical Center in Springfield, Mass.
“This is going to be a learning curve for everyone,” he said.
“The best way to deal with this change is to understand the factors driving costs and morbidity and mortality,” Dr. Kugelmass said, in explaining why he conducted a retrospective study of readmissions within 90 days in a population of 143,286 Medicare beneficiaries hospitalized for acute MI in 2014. The study focus was on readmissions because they add so much to total cost of care for a 90-day episode.
Twenty-eight percent of patients were readmitted at least once within 90 days of discharge following their acute MI. The Medicare bundled payment plan divides MI patients into two separate groups: those who undergo PCI during their initial hospitalization and those who receive medical management only. Thirty-one percent of the readmitted patients in Dr. Kugelmass’s study had undergone PCI during their index hospitalization, while the other 69% were managed medically.
Heart failure was the No. 1 reason for readmission within 90 days in patients who had PCI during the index hospitalization. It was the primary reason for 17.6% of readmissions. Next came recurrent angina or chest pain, which accounted for 6.6% of readmissions; chronic obstructive pulmonary disease or pneumonia, 6.3%; and GI bleeding with hemorrhage, which was the primary reason for 6.0% of readmissions. Together these four causes accounted for more than 36% of all readmissions in the PCI group.
“The GI bleeding data were really interesting,” the cardiologist said. “There’s a lot of talk now about reducing the duration of dual-antiplatelet therapy [DAPT] after PCI. This is an administrative data set that’s quite large, and it shows that GI bleeding in a post-PCI group early in the duration of DAPT is in fact a significant cause of readmission and poses significant hazard.”
Among patients who were medically managed during their index hospitalization, the top four reasons for readmission were heart failure, accounting for 20.6% of readmissions; cardiac surgery, 13.5%; sepsis, 7.8%; and chronic obstructive pulmonary disease/pneumonia, 6.3%. GI bleeding wasn’t a significant cause of readmission in this group.
“I think what we need to do next is dive deeper into the medically managed group. There is a cohort in there that’s incredibly sick and are likely to drive costs and be prone to readmission. And there’s another component of the medically managed group that had to be fairly healthy because they were able to undergo coronary artery bypass surgery within 90 days,” Dr. Kugelmass said.
He reported having no financial conflicts regarding his study.
Key clinical point:
Major finding: Twenty-eight percent of Medicare patients hospitalized for acute MI were readmitted within 90 days.
Data source: A retrospective study of readmissions within 90 days among more than 143,000 Medicare beneficiaries hospitalized for acute MI in 2014.
Disclosures: The study presenter reported having no financial conflicts.
CRT-D beneficial in mild HF with ejection fraction above 30%
WASHINGTON – Patients with mild heart failure symptoms, left bundle branch block, and a left ventricular ejection fraction of 31% to 44% who received cardiac resynchronization therapy with a built-in defibrillator experienced a significant reduction in all-cause mortality, compared with those randomized to an implantable cardioverter-defibrillator alone during 7 years of follow-up.
These results from a new MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) long-term follow-up substudy “suggest that patients with a relatively preserved ejection fraction greater than 30% benefit from CRT-D [cardiac resynchronization therapy defibrillator] and could potentially be considered for this therapy,” said Katherine Vermilye, MD, at the annual meeting of the American College of Cardiology.
In a subsequent publication, the MADIT-CRT investigators reported that, with extension of follow-up to 7 years, CRT-D also provided a significant benefit in terms of all-cause mortality in addition to the reduced rate of heart failure events (N Engl J Med. 2014 May 1;370[18]:1694-701).
However, even though an LVEF of 30% or less was a requirement for participation in MADIT-CRT, it turned out that, when the initial screening echocardiograms were eventually analyzed in a central core laboratory, one-third of study participants actually had a baseline LVEF of 31% to 44%, with the majority of excessive values being in the 31%-35% range.
Dr. Vermilye, of the University of Rochester in New York, presented a post hoc analysis of long-term outcomes in the subgroup having a baseline LVEF greater than 30%. They totaled 450 of 1,224 MADIT-CRT participants with left bundle branch block. They were significantly older and more likely to be female than the 824 subjects with an LVEF of 30% or less. They also had a shorter QRS duration – an average of 160 ms, versus 165 ms in patients with an LVEF of 30% or lower – and a smaller baseline left ventricular end systolic volume of 151 mL, compared with 196 mL in patients with a lower LVEF.
In a multivariate Cox regression analysis adjusted for potential confounders, CRT-D in patients with a baseline LVEF greater than 30% was associated with a 54% reduction in the risk of all-cause mortality at 7 years of follow-up, compared with receipt of an ICD-only device and with a smaller yet significant 31% reduction in risk in those with an LVEF of 30% or less. Worsening heart failure events were reduced by 64% in patients with a baseline LVEF greater than 30% who received CRT-D, compared with ICD-only, and by 54% in those with a lower baseline LVEF.
The reduction in all-cause mortality seen with CRT-D was confined to patients who were high responders to CRT as defined echocardiographically by at least a 35% change in left ventricular end systolic volume 1 year post implantation. They had an 85% reduction in the risk of death during 7 years of follow-up with CRT-D if their baseline LVEF was greater than 30% and a 58% relative risk reduction if their LVEF was 30% or less.
In contrast, CRT-D brought a significantly reduced risk of heart failure events regardless of whether a patient was a low or high responder, although the magnitude of benefit was greater in the high responders. Among patients with a baseline LVEF greater than 30%, CRT-D low responders had a 52% reduction in risk of heart failure events, compared with ICD recipients, while CRT-D high responders had an 81% relative risk reduction. Similarly, in patients with a baseline LVEF of 30% or less, CRT-D low responders had 48% reduction in heart failure events and high responders had a 79% risk reduction, compared with the ICD-only group.
Because this is a post hoc analysis, these new MADIT-CRT findings require validation in future studies, Dr. Vermilye observed.
MADIT-CRT was supported by Boston Scientific. Dr.. Vermilye reported having no financial conflicts.
WASHINGTON – Patients with mild heart failure symptoms, left bundle branch block, and a left ventricular ejection fraction of 31% to 44% who received cardiac resynchronization therapy with a built-in defibrillator experienced a significant reduction in all-cause mortality, compared with those randomized to an implantable cardioverter-defibrillator alone during 7 years of follow-up.
These results from a new MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) long-term follow-up substudy “suggest that patients with a relatively preserved ejection fraction greater than 30% benefit from CRT-D [cardiac resynchronization therapy defibrillator] and could potentially be considered for this therapy,” said Katherine Vermilye, MD, at the annual meeting of the American College of Cardiology.
In a subsequent publication, the MADIT-CRT investigators reported that, with extension of follow-up to 7 years, CRT-D also provided a significant benefit in terms of all-cause mortality in addition to the reduced rate of heart failure events (N Engl J Med. 2014 May 1;370[18]:1694-701).
However, even though an LVEF of 30% or less was a requirement for participation in MADIT-CRT, it turned out that, when the initial screening echocardiograms were eventually analyzed in a central core laboratory, one-third of study participants actually had a baseline LVEF of 31% to 44%, with the majority of excessive values being in the 31%-35% range.
Dr. Vermilye, of the University of Rochester in New York, presented a post hoc analysis of long-term outcomes in the subgroup having a baseline LVEF greater than 30%. They totaled 450 of 1,224 MADIT-CRT participants with left bundle branch block. They were significantly older and more likely to be female than the 824 subjects with an LVEF of 30% or less. They also had a shorter QRS duration – an average of 160 ms, versus 165 ms in patients with an LVEF of 30% or lower – and a smaller baseline left ventricular end systolic volume of 151 mL, compared with 196 mL in patients with a lower LVEF.
In a multivariate Cox regression analysis adjusted for potential confounders, CRT-D in patients with a baseline LVEF greater than 30% was associated with a 54% reduction in the risk of all-cause mortality at 7 years of follow-up, compared with receipt of an ICD-only device and with a smaller yet significant 31% reduction in risk in those with an LVEF of 30% or less. Worsening heart failure events were reduced by 64% in patients with a baseline LVEF greater than 30% who received CRT-D, compared with ICD-only, and by 54% in those with a lower baseline LVEF.
The reduction in all-cause mortality seen with CRT-D was confined to patients who were high responders to CRT as defined echocardiographically by at least a 35% change in left ventricular end systolic volume 1 year post implantation. They had an 85% reduction in the risk of death during 7 years of follow-up with CRT-D if their baseline LVEF was greater than 30% and a 58% relative risk reduction if their LVEF was 30% or less.
In contrast, CRT-D brought a significantly reduced risk of heart failure events regardless of whether a patient was a low or high responder, although the magnitude of benefit was greater in the high responders. Among patients with a baseline LVEF greater than 30%, CRT-D low responders had a 52% reduction in risk of heart failure events, compared with ICD recipients, while CRT-D high responders had an 81% relative risk reduction. Similarly, in patients with a baseline LVEF of 30% or less, CRT-D low responders had 48% reduction in heart failure events and high responders had a 79% risk reduction, compared with the ICD-only group.
Because this is a post hoc analysis, these new MADIT-CRT findings require validation in future studies, Dr. Vermilye observed.
MADIT-CRT was supported by Boston Scientific. Dr.. Vermilye reported having no financial conflicts.
WASHINGTON – Patients with mild heart failure symptoms, left bundle branch block, and a left ventricular ejection fraction of 31% to 44% who received cardiac resynchronization therapy with a built-in defibrillator experienced a significant reduction in all-cause mortality, compared with those randomized to an implantable cardioverter-defibrillator alone during 7 years of follow-up.
These results from a new MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) long-term follow-up substudy “suggest that patients with a relatively preserved ejection fraction greater than 30% benefit from CRT-D [cardiac resynchronization therapy defibrillator] and could potentially be considered for this therapy,” said Katherine Vermilye, MD, at the annual meeting of the American College of Cardiology.
In a subsequent publication, the MADIT-CRT investigators reported that, with extension of follow-up to 7 years, CRT-D also provided a significant benefit in terms of all-cause mortality in addition to the reduced rate of heart failure events (N Engl J Med. 2014 May 1;370[18]:1694-701).
However, even though an LVEF of 30% or less was a requirement for participation in MADIT-CRT, it turned out that, when the initial screening echocardiograms were eventually analyzed in a central core laboratory, one-third of study participants actually had a baseline LVEF of 31% to 44%, with the majority of excessive values being in the 31%-35% range.
Dr. Vermilye, of the University of Rochester in New York, presented a post hoc analysis of long-term outcomes in the subgroup having a baseline LVEF greater than 30%. They totaled 450 of 1,224 MADIT-CRT participants with left bundle branch block. They were significantly older and more likely to be female than the 824 subjects with an LVEF of 30% or less. They also had a shorter QRS duration – an average of 160 ms, versus 165 ms in patients with an LVEF of 30% or lower – and a smaller baseline left ventricular end systolic volume of 151 mL, compared with 196 mL in patients with a lower LVEF.
In a multivariate Cox regression analysis adjusted for potential confounders, CRT-D in patients with a baseline LVEF greater than 30% was associated with a 54% reduction in the risk of all-cause mortality at 7 years of follow-up, compared with receipt of an ICD-only device and with a smaller yet significant 31% reduction in risk in those with an LVEF of 30% or less. Worsening heart failure events were reduced by 64% in patients with a baseline LVEF greater than 30% who received CRT-D, compared with ICD-only, and by 54% in those with a lower baseline LVEF.
The reduction in all-cause mortality seen with CRT-D was confined to patients who were high responders to CRT as defined echocardiographically by at least a 35% change in left ventricular end systolic volume 1 year post implantation. They had an 85% reduction in the risk of death during 7 years of follow-up with CRT-D if their baseline LVEF was greater than 30% and a 58% relative risk reduction if their LVEF was 30% or less.
In contrast, CRT-D brought a significantly reduced risk of heart failure events regardless of whether a patient was a low or high responder, although the magnitude of benefit was greater in the high responders. Among patients with a baseline LVEF greater than 30%, CRT-D low responders had a 52% reduction in risk of heart failure events, compared with ICD recipients, while CRT-D high responders had an 81% relative risk reduction. Similarly, in patients with a baseline LVEF of 30% or less, CRT-D low responders had 48% reduction in heart failure events and high responders had a 79% risk reduction, compared with the ICD-only group.
Because this is a post hoc analysis, these new MADIT-CRT findings require validation in future studies, Dr. Vermilye observed.
MADIT-CRT was supported by Boston Scientific. Dr.. Vermilye reported having no financial conflicts.
AT ACC 2017
Key clinical point:
Major finding: The risk of all-cause mortality was reduced by 54% with CRT-D as compared with an ICD alone in MADIT-CRT participants with a baseline LVEF greater than 30% and by 31% in those with an LVEF of 30% or lower.
Data source: An analysis of 7-year rates of all-cause mortality and worsening heart failure events in 1,224 MADIT-CRT participants with left bundle branch block, 450 of whom had a baseline LVEF greater than 30%.
Disclosures: The MADIT-CRT study was supported by Boston Scientific. The presenter reported having no financial conflicts.
Use of second-generation antidepressants in older adults is associated with increased hospitalization with hyponatremia
Clinical Question: Is there an increased risk of hyponatremia for older patients who are taking a second-generation antidepressant?
Background: Mood and anxiety disorders affect about one in eight older adults, and second-generation antidepressants are frequently recommended for treatment. A potential adverse effect of these agents is hyponatremia, which can lead to serious sequelae. The aim of this study was to investigate the 30-day risk for hospitalization with hyponatremia in older adults who were newly started on a second-generation antidepressant.
Setting: Ontario, Canada.
Synopsis: Multiple databases were utilized to obtain vital statistics and demographic information, diagnoses, prescriptions, and serum sodium measurements to establish a cohort population. One group of 172,552 was newly prescribed a second-generation antidepressant. A second control group of 297,501 was established in which patients were not prescribed antidepressants. Greedy matching was used to match each user to a nonuser based on similar characteristics of age, sex, evidence of mood disorder, chronic kidney disease, congestive heart failure, or diuretic use. After matching, 138,246 patients remained in each group and were nearly identical for all 10 0 measured characteristics. The primary outcome was that, compared with nonuse, second-generation antidepressant use was associated with higher 30-day risk of hospitalization with hyponatremia (relative risk, 5.46; 95% CI, 4.32-6.91). The secondary outcome showed that, compared with non-use, second-generation antidepressant use was associated with higher 30-day risk for hospitalization with concomitant hyponatremia and delirium (RR, 4.00; 95% CI, 1.74 - 9.16). Additionally, tests for specificity and temporality were employed.
Bottom Line: A robust association between second-generation antidepressant use and hospitalization with hyponatremia was determined in the large population-based cohort study.
Citation: Gandhi S, Shariff SZ, Al-Jaishi A, et al. “Second-generation antidepressants and hyponatremia risk: a population-based cohort study of older adults.” Am J Kidney Dis. 2017 Jan;69(1):87-96.
Dr. Kim is clinical assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
Clinical Question: Is there an increased risk of hyponatremia for older patients who are taking a second-generation antidepressant?
Background: Mood and anxiety disorders affect about one in eight older adults, and second-generation antidepressants are frequently recommended for treatment. A potential adverse effect of these agents is hyponatremia, which can lead to serious sequelae. The aim of this study was to investigate the 30-day risk for hospitalization with hyponatremia in older adults who were newly started on a second-generation antidepressant.
Setting: Ontario, Canada.
Synopsis: Multiple databases were utilized to obtain vital statistics and demographic information, diagnoses, prescriptions, and serum sodium measurements to establish a cohort population. One group of 172,552 was newly prescribed a second-generation antidepressant. A second control group of 297,501 was established in which patients were not prescribed antidepressants. Greedy matching was used to match each user to a nonuser based on similar characteristics of age, sex, evidence of mood disorder, chronic kidney disease, congestive heart failure, or diuretic use. After matching, 138,246 patients remained in each group and were nearly identical for all 10 0 measured characteristics. The primary outcome was that, compared with nonuse, second-generation antidepressant use was associated with higher 30-day risk of hospitalization with hyponatremia (relative risk, 5.46; 95% CI, 4.32-6.91). The secondary outcome showed that, compared with non-use, second-generation antidepressant use was associated with higher 30-day risk for hospitalization with concomitant hyponatremia and delirium (RR, 4.00; 95% CI, 1.74 - 9.16). Additionally, tests for specificity and temporality were employed.
Bottom Line: A robust association between second-generation antidepressant use and hospitalization with hyponatremia was determined in the large population-based cohort study.
Citation: Gandhi S, Shariff SZ, Al-Jaishi A, et al. “Second-generation antidepressants and hyponatremia risk: a population-based cohort study of older adults.” Am J Kidney Dis. 2017 Jan;69(1):87-96.
Dr. Kim is clinical assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
Clinical Question: Is there an increased risk of hyponatremia for older patients who are taking a second-generation antidepressant?
Background: Mood and anxiety disorders affect about one in eight older adults, and second-generation antidepressants are frequently recommended for treatment. A potential adverse effect of these agents is hyponatremia, which can lead to serious sequelae. The aim of this study was to investigate the 30-day risk for hospitalization with hyponatremia in older adults who were newly started on a second-generation antidepressant.
Setting: Ontario, Canada.
Synopsis: Multiple databases were utilized to obtain vital statistics and demographic information, diagnoses, prescriptions, and serum sodium measurements to establish a cohort population. One group of 172,552 was newly prescribed a second-generation antidepressant. A second control group of 297,501 was established in which patients were not prescribed antidepressants. Greedy matching was used to match each user to a nonuser based on similar characteristics of age, sex, evidence of mood disorder, chronic kidney disease, congestive heart failure, or diuretic use. After matching, 138,246 patients remained in each group and were nearly identical for all 10 0 measured characteristics. The primary outcome was that, compared with nonuse, second-generation antidepressant use was associated with higher 30-day risk of hospitalization with hyponatremia (relative risk, 5.46; 95% CI, 4.32-6.91). The secondary outcome showed that, compared with non-use, second-generation antidepressant use was associated with higher 30-day risk for hospitalization with concomitant hyponatremia and delirium (RR, 4.00; 95% CI, 1.74 - 9.16). Additionally, tests for specificity and temporality were employed.
Bottom Line: A robust association between second-generation antidepressant use and hospitalization with hyponatremia was determined in the large population-based cohort study.
Citation: Gandhi S, Shariff SZ, Al-Jaishi A, et al. “Second-generation antidepressants and hyponatremia risk: a population-based cohort study of older adults.” Am J Kidney Dis. 2017 Jan;69(1):87-96.
Dr. Kim is clinical assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
Guideline for reversal of antithrombotics in intracranial hemorrhage
Clinical Question: What is the current guideline for reversal of antithrombotics in intracranial hemorrhage (ICH)?
Background: Antithrombotics are used to treat or decrease the risk of thromboembolic events, and the use is expected to rise in the future because of an aging population and conditions such as atrial fibrillation. Patients on antithrombotics who experience spontaneous ICH have a higher risk of death or poor outcome, compared with those who are not. Rapid reversal of coagulopathy may help to improve outcomes.
Study design: A 13-person, multi-institutional, international committee with expertise in relevant medical fields reviewed a total of 488 articles to develop guidelines and treatment recommendations.
Synopsis: The committee developed guidelines for the reversal of antithrombotics after reviewing a total of 488 articles up through November 2015. The quality of evidence and treatment recommendations were drafted based on the GRADE system, as follows:
• Vitamin K antagonists: If international normalized ratio is greater than or equal to 1.4, administer vitamin K 10 mg IV, plus 3-4 factor prothrombin complex concentrate (PCC) or fresh frozen plasma.
• Direct factor Xa inhibitors: activated charcoal within 2 hr of ingestion, activated PCC or 4 factor PCC.
• Direct thrombin inhibitors – Dabigatran: activated charcoal within 2 hr of ingestion and Idarucizumab. Consider hemodialysis. Other DTIs: activated PCC or 4 factor PCC.
• Unfractionated heparin: protamine IV.
• Low-molecular-weight heparins – Enoxaparin: protamine IV, dose based on time of enoxaparin administration. Dalteparin/nadroparin/tinzaparin: protamine IV or recombinant factor (rF)VIIa.
• Danaparoid: rFVIIa.
• Pentasaccharides: activated PCC.
• Thrombolytic agents: cryoprecipitate 10 units or antifibrinolytics.
• Antiplatelet agents: desmopressin 0.4 mcg or platelet transfusion in neurosurgical procedure.
Bottom Line: This is a statement of the guideline for reversal of antithrombotics in intracranial hemorrhage from the Neurocritical Care Society and the Society of Critical Care Medicine.
Citation: Frontera J, Lewin JJ, Rabinstein AA, et al. “Guideline for reversal of antithrombotics in intracranial hemorrhage: a statement for healthcare professionals from the Neurocritical Care Society and Society of Critical Care Medicine.” Neurocrit Care. 2016 Feb;24(1):6-46.
Dr. Kim is clinical assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
Clinical Question: What is the current guideline for reversal of antithrombotics in intracranial hemorrhage (ICH)?
Background: Antithrombotics are used to treat or decrease the risk of thromboembolic events, and the use is expected to rise in the future because of an aging population and conditions such as atrial fibrillation. Patients on antithrombotics who experience spontaneous ICH have a higher risk of death or poor outcome, compared with those who are not. Rapid reversal of coagulopathy may help to improve outcomes.
Study design: A 13-person, multi-institutional, international committee with expertise in relevant medical fields reviewed a total of 488 articles to develop guidelines and treatment recommendations.
Synopsis: The committee developed guidelines for the reversal of antithrombotics after reviewing a total of 488 articles up through November 2015. The quality of evidence and treatment recommendations were drafted based on the GRADE system, as follows:
• Vitamin K antagonists: If international normalized ratio is greater than or equal to 1.4, administer vitamin K 10 mg IV, plus 3-4 factor prothrombin complex concentrate (PCC) or fresh frozen plasma.
• Direct factor Xa inhibitors: activated charcoal within 2 hr of ingestion, activated PCC or 4 factor PCC.
• Direct thrombin inhibitors – Dabigatran: activated charcoal within 2 hr of ingestion and Idarucizumab. Consider hemodialysis. Other DTIs: activated PCC or 4 factor PCC.
• Unfractionated heparin: protamine IV.
• Low-molecular-weight heparins – Enoxaparin: protamine IV, dose based on time of enoxaparin administration. Dalteparin/nadroparin/tinzaparin: protamine IV or recombinant factor (rF)VIIa.
• Danaparoid: rFVIIa.
• Pentasaccharides: activated PCC.
• Thrombolytic agents: cryoprecipitate 10 units or antifibrinolytics.
• Antiplatelet agents: desmopressin 0.4 mcg or platelet transfusion in neurosurgical procedure.
Bottom Line: This is a statement of the guideline for reversal of antithrombotics in intracranial hemorrhage from the Neurocritical Care Society and the Society of Critical Care Medicine.
Citation: Frontera J, Lewin JJ, Rabinstein AA, et al. “Guideline for reversal of antithrombotics in intracranial hemorrhage: a statement for healthcare professionals from the Neurocritical Care Society and Society of Critical Care Medicine.” Neurocrit Care. 2016 Feb;24(1):6-46.
Dr. Kim is clinical assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
Clinical Question: What is the current guideline for reversal of antithrombotics in intracranial hemorrhage (ICH)?
Background: Antithrombotics are used to treat or decrease the risk of thromboembolic events, and the use is expected to rise in the future because of an aging population and conditions such as atrial fibrillation. Patients on antithrombotics who experience spontaneous ICH have a higher risk of death or poor outcome, compared with those who are not. Rapid reversal of coagulopathy may help to improve outcomes.
Study design: A 13-person, multi-institutional, international committee with expertise in relevant medical fields reviewed a total of 488 articles to develop guidelines and treatment recommendations.
Synopsis: The committee developed guidelines for the reversal of antithrombotics after reviewing a total of 488 articles up through November 2015. The quality of evidence and treatment recommendations were drafted based on the GRADE system, as follows:
• Vitamin K antagonists: If international normalized ratio is greater than or equal to 1.4, administer vitamin K 10 mg IV, plus 3-4 factor prothrombin complex concentrate (PCC) or fresh frozen plasma.
• Direct factor Xa inhibitors: activated charcoal within 2 hr of ingestion, activated PCC or 4 factor PCC.
• Direct thrombin inhibitors – Dabigatran: activated charcoal within 2 hr of ingestion and Idarucizumab. Consider hemodialysis. Other DTIs: activated PCC or 4 factor PCC.
• Unfractionated heparin: protamine IV.
• Low-molecular-weight heparins – Enoxaparin: protamine IV, dose based on time of enoxaparin administration. Dalteparin/nadroparin/tinzaparin: protamine IV or recombinant factor (rF)VIIa.
• Danaparoid: rFVIIa.
• Pentasaccharides: activated PCC.
• Thrombolytic agents: cryoprecipitate 10 units or antifibrinolytics.
• Antiplatelet agents: desmopressin 0.4 mcg or platelet transfusion in neurosurgical procedure.
Bottom Line: This is a statement of the guideline for reversal of antithrombotics in intracranial hemorrhage from the Neurocritical Care Society and the Society of Critical Care Medicine.
Citation: Frontera J, Lewin JJ, Rabinstein AA, et al. “Guideline for reversal of antithrombotics in intracranial hemorrhage: a statement for healthcare professionals from the Neurocritical Care Society and Society of Critical Care Medicine.” Neurocrit Care. 2016 Feb;24(1):6-46.
Dr. Kim is clinical assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.