Heart Failure

AMSTERDAM – People infected with HIV had a 66% increased rate of developing heart failure – compared with matched, uninfected people – that was independent of any other cardiovascular disease risk factor in a study of roughly 425,000 individuals from a large U.S. health care system.

“HIV infection is independently associated with a higher risk for developing heart failure, and this excess risk does not appear mediated through atherosclerotic disease pathways or differential use of cardioprotective medications,” Alan S. Go, MD, said at the 22nd International AIDS Conference.

The finding sends two important messages to physicians who care for people living with HIV, Dr. Go said in a video interview. First, have “greater awareness for the risk of heart failure” in people living with HIV, even in those who have excellent [HIV] treatment. Be on the lookout, he recommended, for classic symptoms of heart failure like dyspnea and fatigue, and if found follow-up with an assessment of heart function, usually by echocardiography. The second message is to pay attention to and aggressively treat risk factors for heart failure, such as hypertension, smoking, obesity, diabetes, and hypercholesterolemia, said Dr. Go, director of the Comprehensive Clinical Research Unit of Kaiser Permanente in Oakland, Calif.

Results from a small number of prior studies also suggested an increased heart failure rate in people infected with HIV, but those reports had not been able to untangle this observed increase from a possible relationship to the elevated rate of MIs among people living with HIV. The study led by Dr. Go adjusted for acute coronary syndrome events that occurred during follow-up in the analysis and this showed that the increased incidence of heart failure occurred independently of any preceding MI or unstable angina event.

Dr. Go proposed several potential mechanisms that could tie HIV infection to an elevated heart failure risk that was not linked to a prior ischemic heart disease event. The virus could directly damage cardiac myocytes to produce fibrosis, the virus could trigger cardiac inflammation, and the infected person could have an increased susceptibility to infection by a pathogen know to potentially cause cardiac damage and myocarditis such as coxsackievirus.

For the time being, patients infected by HIV who develop heart failure should receive the same treatments that are recommended for the general population, Dr. Go said, but he also highlighted the need for further study to determine the effectiveness of standard heart failure treatments specifically in people living with HIV. He and his associates are also currently analyzing the relationship of several other variables to the risk for heart failure in HIV-infected people, such as the degree of HIV control, and the types of antiretroviral therapy that patients receive. So far the study has not shown a relationship between HIV infection and any specific type of heart failure. About a quarter of the HIV-infected people who developed heart failure in this study had reduced left ventricular ejection fraction, about a quarter had preserved ejection fraction, and for the remaining patients information on their left ventricular ejection fraction was not available, Dr. Go said.

The Kaiser Permanente HIV Heart Study used data from health records from about 13.5 million people enrolled in the health system during 2000-2016 at locations in northern California, southern California, or the mid-Atlantic region. From these records the researchers identified 38,868 people diagnosed with an HIV infection, free of a heart failure diagnosis, and at least 21 years old, and matched them by age, sex, and race with 386,586 people in the health system who were both uninfected and free of heart failure. At “baseline” in the analysis the two study groups had very similar rates of smoking, but those with HIV had somewhat more alcohol abuse and nearly twice the rate of illicit drug use, although even among those with HIV this rate was low at 4%.

Some clinical characteristics at baseline showed significant differences between the two groups. People living with HIV had substantially less hypertension, 7% compared with 12% in those without HIV; half the rate of dyslipidemia, 8% compared with 16% among the control group; and nearly half the prevalence of diabetes, 3% versus 5% among those without HIV. On the other hand, certain other clinical characteristics were more common among those with HIV. The prevalence at baseline of diagnosed dementia was 15% among people infected with HIV and essentially nonexistent (less than 1%) among controls, and the prevalence of diagnosed depression was 8% among people with HIV and 5% among those without the infection.

Baseline parameters also showed that at the time this review first identified a person with HIV and without heart failure in the system records only 18% of the HIV-infected individuals were on an antiretroviral therapy regimen. Dr. Go said that the study is currently analyzing subsequent HIV treatments that these patients may have received. Also at “baseline” 13% of people with documented HIV infection had a CD4 cell count of fewer than 200 cell/mm³, with 4% having fewer than 50 CD4 cells/mm³, and 29% of those with HIV had a blood level of at least 500 copies of HIV RNA/mL. In addition, information on CD4 cell counts was unavailable for 43% of these people, and information on viral load was unavailable for about half.

During “follow-up” in the system’s medical records for a period of up to 17 years, diagnoses of incident heart failure accumulated significantly faster among people with HIV compared to those without HIV. After adjustment for demographic differences, the time of entry into the health system, cardiovascular and other medical differences, and differences in medication use, people living with HIV had a 75% higher rate of incident heart failure compared with those without HIV. Further adjustment based on incident first episodes of acute coronary syndrome during “follow-up” brought the excess rate of heart failure to 66% higher among people infected by HIV, Dr. Go reported. He cautioned that the findings came from a U.S. population that had access to comprehensive health care.

mzoler@mdedge.com

SOURCE: Go AS et al. AIDS 2018, Abstract 2778, THAB0103.

AMSTERDAM – People infected with HIV had a 66% increased rate of developing heart failure – compared with matched, uninfected people – that was independent of any other cardiovascular disease risk factor in a study of roughly 425,000 individuals from a large U.S. health care system.

“HIV infection is independently associated with a higher risk for developing heart failure, and this excess risk does not appear mediated through atherosclerotic disease pathways or differential use of cardioprotective medications,” Alan S. Go, MD, said at the 22nd International AIDS Conference.

The finding sends two important messages to physicians who care for people living with HIV, Dr. Go said in a video interview. First, have “greater awareness for the risk of heart failure” in people living with HIV, even in those who have excellent [HIV] treatment. Be on the lookout, he recommended, for classic symptoms of heart failure like dyspnea and fatigue, and if found follow-up with an assessment of heart function, usually by echocardiography. The second message is to pay attention to and aggressively treat risk factors for heart failure, such as hypertension, smoking, obesity, diabetes, and hypercholesterolemia, said Dr. Go, director of the Comprehensive Clinical Research Unit of Kaiser Permanente in Oakland, Calif.

Results from a small number of prior studies also suggested an increased heart failure rate in people infected with HIV, but those reports had not been able to untangle this observed increase from a possible relationship to the elevated rate of MIs among people living with HIV. The study led by Dr. Go adjusted for acute coronary syndrome events that occurred during follow-up in the analysis and this showed that the increased incidence of heart failure occurred independently of any preceding MI or unstable angina event.

Dr. Go proposed several potential mechanisms that could tie HIV infection to an elevated heart failure risk that was not linked to a prior ischemic heart disease event. The virus could directly damage cardiac myocytes to produce fibrosis, the virus could trigger cardiac inflammation, and the infected person could have an increased susceptibility to infection by a pathogen know to potentially cause cardiac damage and myocarditis such as coxsackievirus.

For the time being, patients infected by HIV who develop heart failure should receive the same treatments that are recommended for the general population, Dr. Go said, but he also highlighted the need for further study to determine the effectiveness of standard heart failure treatments specifically in people living with HIV. He and his associates are also currently analyzing the relationship of several other variables to the risk for heart failure in HIV-infected people, such as the degree of HIV control, and the types of antiretroviral therapy that patients receive. So far the study has not shown a relationship between HIV infection and any specific type of heart failure. About a quarter of the HIV-infected people who developed heart failure in this study had reduced left ventricular ejection fraction, about a quarter had preserved ejection fraction, and for the remaining patients information on their left ventricular ejection fraction was not available, Dr. Go said.

The Kaiser Permanente HIV Heart Study used data from health records from about 13.5 million people enrolled in the health system during 2000-2016 at locations in northern California, southern California, or the mid-Atlantic region. From these records the researchers identified 38,868 people diagnosed with an HIV infection, free of a heart failure diagnosis, and at least 21 years old, and matched them by age, sex, and race with 386,586 people in the health system who were both uninfected and free of heart failure. At “baseline” in the analysis the two study groups had very similar rates of smoking, but those with HIV had somewhat more alcohol abuse and nearly twice the rate of illicit drug use, although even among those with HIV this rate was low at 4%.

Some clinical characteristics at baseline showed significant differences between the two groups. People living with HIV had substantially less hypertension, 7% compared with 12% in those without HIV; half the rate of dyslipidemia, 8% compared with 16% among the control group; and nearly half the prevalence of diabetes, 3% versus 5% among those without HIV. On the other hand, certain other clinical characteristics were more common among those with HIV. The prevalence at baseline of diagnosed dementia was 15% among people infected with HIV and essentially nonexistent (less than 1%) among controls, and the prevalence of diagnosed depression was 8% among people with HIV and 5% among those without the infection.

Baseline parameters also showed that at the time this review first identified a person with HIV and without heart failure in the system records only 18% of the HIV-infected individuals were on an antiretroviral therapy regimen. Dr. Go said that the study is currently analyzing subsequent HIV treatments that these patients may have received. Also at “baseline” 13% of people with documented HIV infection had a CD4 cell count of fewer than 200 cell/mm³, with 4% having fewer than 50 CD4 cells/mm³, and 29% of those with HIV had a blood level of at least 500 copies of HIV RNA/mL. In addition, information on CD4 cell counts was unavailable for 43% of these people, and information on viral load was unavailable for about half.

During “follow-up” in the system’s medical records for a period of up to 17 years, diagnoses of incident heart failure accumulated significantly faster among people with HIV compared to those without HIV. After adjustment for demographic differences, the time of entry into the health system, cardiovascular and other medical differences, and differences in medication use, people living with HIV had a 75% higher rate of incident heart failure compared with those without HIV. Further adjustment based on incident first episodes of acute coronary syndrome during “follow-up” brought the excess rate of heart failure to 66% higher among people infected by HIV, Dr. Go reported. He cautioned that the findings came from a U.S. population that had access to comprehensive health care.

mzoler@mdedge.com

SOURCE: Go AS et al. AIDS 2018, Abstract 2778, THAB0103.

AMSTERDAM – People infected with HIV had a 66% increased rate of developing heart failure – compared with matched, uninfected people – that was independent of any other cardiovascular disease risk factor in a study of roughly 425,000 individuals from a large U.S. health care system.

“HIV infection is independently associated with a higher risk for developing heart failure, and this excess risk does not appear mediated through atherosclerotic disease pathways or differential use of cardioprotective medications,” Alan S. Go, MD, said at the 22nd International AIDS Conference.

The finding sends two important messages to physicians who care for people living with HIV, Dr. Go said in a video interview. First, have “greater awareness for the risk of heart failure” in people living with HIV, even in those who have excellent [HIV] treatment. Be on the lookout, he recommended, for classic symptoms of heart failure like dyspnea and fatigue, and if found follow-up with an assessment of heart function, usually by echocardiography. The second message is to pay attention to and aggressively treat risk factors for heart failure, such as hypertension, smoking, obesity, diabetes, and hypercholesterolemia, said Dr. Go, director of the Comprehensive Clinical Research Unit of Kaiser Permanente in Oakland, Calif.

Results from a small number of prior studies also suggested an increased heart failure rate in people infected with HIV, but those reports had not been able to untangle this observed increase from a possible relationship to the elevated rate of MIs among people living with HIV. The study led by Dr. Go adjusted for acute coronary syndrome events that occurred during follow-up in the analysis and this showed that the increased incidence of heart failure occurred independently of any preceding MI or unstable angina event.

Dr. Go proposed several potential mechanisms that could tie HIV infection to an elevated heart failure risk that was not linked to a prior ischemic heart disease event. The virus could directly damage cardiac myocytes to produce fibrosis, the virus could trigger cardiac inflammation, and the infected person could have an increased susceptibility to infection by a pathogen know to potentially cause cardiac damage and myocarditis such as coxsackievirus.

For the time being, patients infected by HIV who develop heart failure should receive the same treatments that are recommended for the general population, Dr. Go said, but he also highlighted the need for further study to determine the effectiveness of standard heart failure treatments specifically in people living with HIV. He and his associates are also currently analyzing the relationship of several other variables to the risk for heart failure in HIV-infected people, such as the degree of HIV control, and the types of antiretroviral therapy that patients receive. So far the study has not shown a relationship between HIV infection and any specific type of heart failure. About a quarter of the HIV-infected people who developed heart failure in this study had reduced left ventricular ejection fraction, about a quarter had preserved ejection fraction, and for the remaining patients information on their left ventricular ejection fraction was not available, Dr. Go said.

The Kaiser Permanente HIV Heart Study used data from health records from about 13.5 million people enrolled in the health system during 2000-2016 at locations in northern California, southern California, or the mid-Atlantic region. From these records the researchers identified 38,868 people diagnosed with an HIV infection, free of a heart failure diagnosis, and at least 21 years old, and matched them by age, sex, and race with 386,586 people in the health system who were both uninfected and free of heart failure. At “baseline” in the analysis the two study groups had very similar rates of smoking, but those with HIV had somewhat more alcohol abuse and nearly twice the rate of illicit drug use, although even among those with HIV this rate was low at 4%.

Some clinical characteristics at baseline showed significant differences between the two groups. People living with HIV had substantially less hypertension, 7% compared with 12% in those without HIV; half the rate of dyslipidemia, 8% compared with 16% among the control group; and nearly half the prevalence of diabetes, 3% versus 5% among those without HIV. On the other hand, certain other clinical characteristics were more common among those with HIV. The prevalence at baseline of diagnosed dementia was 15% among people infected with HIV and essentially nonexistent (less than 1%) among controls, and the prevalence of diagnosed depression was 8% among people with HIV and 5% among those without the infection.

Baseline parameters also showed that at the time this review first identified a person with HIV and without heart failure in the system records only 18% of the HIV-infected individuals were on an antiretroviral therapy regimen. Dr. Go said that the study is currently analyzing subsequent HIV treatments that these patients may have received. Also at “baseline” 13% of people with documented HIV infection had a CD4 cell count of fewer than 200 cell/mm³, with 4% having fewer than 50 CD4 cells/mm³, and 29% of those with HIV had a blood level of at least 500 copies of HIV RNA/mL. In addition, information on CD4 cell counts was unavailable for 43% of these people, and information on viral load was unavailable for about half.

During “follow-up” in the system’s medical records for a period of up to 17 years, diagnoses of incident heart failure accumulated significantly faster among people with HIV compared to those without HIV. After adjustment for demographic differences, the time of entry into the health system, cardiovascular and other medical differences, and differences in medication use, people living with HIV had a 75% higher rate of incident heart failure compared with those without HIV. Further adjustment based on incident first episodes of acute coronary syndrome during “follow-up” brought the excess rate of heart failure to 66% higher among people infected by HIV, Dr. Go reported. He cautioned that the findings came from a U.S. population that had access to comprehensive health care.

mzoler@mdedge.com

SOURCE: Go AS et al. AIDS 2018, Abstract 2778, THAB0103.

Patients with both chronic obstructive pulmonary disease (COPD) and heart failure (HF) are prone to hospital readmissions that detract from quality of life and dramatically drive up care costs.

Because the two chronic diseases spring from the same root cause and share overlapping symptoms, strategies that improve clinical outcomes in one can also benefit the other, Ravi Kalhan, MD, and R. Kannan Mutharasan, MD, wrote in CHEST Journal (doi: 10.1016/j.chest.2018.06.001).

“Both conditions are characterized by periods of clinical stability punctuated by episodes of exacerbation and are typified by gradual functional decline,” wrote the colleagues, both of Northwestern University, Chicago. “From a patient perspective, both conditions lead to highly overlapping patterns of symptoms, involve complicated medication regimens, and have courses highly sensitive to adherence and lifestyle modification. Therefore, disease management strategies for both conditions can be synergistic.”

The team came up with a “Top 10 list” of practical tips for reducing readmissions in patients with this challenging combination.
 

Diagnose accurately

An acute hospitalization is often the first time these patients pop up on the radar. This is a great time to employ spirometry to accurately diagnose COPD. It’s also appropriate to conduct a chest CT and check right heart size, diameter of the pulmonary artery, and the presence of coronary calcification. The authors noted that relatively little is known about the course of patients with combined asthma and HF in contrast to COPD and HF.

Detect admissions for exacerbations early

Check soon to find out if this is a readmission, get an acute plan going, and don’t wait to implement multidisciplinary interventions. “First, specialist involvement can occur more rapidly, allowing for faster identification of any root causes driving the HF or COPD syndromes, and allowing for more rapid institution of treatment plans to control the acute exacerbation. Second, early identification during hospitalization allows time to deploy multidisciplinary interventions, such as disease management education, social work evaluation, follow-up appointment scheduling, and coordination of home services. These interventions are less effective, and are often not implemented, if initiated toward the end of hospitalization.”

Use specialist management in the hospital

Get experts on board fast. An integrated team means a coordinated treatment plan that’s easier to follow and more effective therapeutically. Specialist care may impact rates of readmission: weight loss with diuretics; discharge doses of guideline-directed medical therapy for heart failure; and higher rates of discharge on long-acting beta-agonists, long-acting muscarinic antagonists, inhaled corticosteroids, and home supplemental oxygen.

Modify the underlying disease substrate

Heart failure is more likely to arise from a correctable pathophysiology, so find it early and treat it thoroughly – especially in younger patients. Ischemic heart disease, valvular heart disease, systemic hypertension, and pulmonary hypertension all have potential to make the HF syndrome more tractable.

Apply and intensify evidence-based therapies

Start in the hospital if possible; if not, begin upon discharge. “The order of application of these therapies can be bewildering, as many strategies for initiation and up-titration of these medications are reasonable. Not only are there long-term outcome benefits for these therapies, evidence suggests early initiation of HF therapies can reduce 30-day readmissions.”

Activate the patient and develop critical health behaviors

Medical regimens for these diseases can be complex, and they must be supported by patient engagement. “Many strategies for engaging patients in care have been tested, including teaching to goal, motivational interviewing, and teach-back methods of activation and engagement. Often these methods are time intensive. Because physician time is increasingly constrained, a team approach is particularly useful.”

Set up feedback loops

“Course correction should the patient decompensate is critically important to maintaining outpatient success. Feedback loops can allow for clinical stabilization before rehospitalization is necessary.” Self-monitoring with individually set benchmarks is critical.

Arrange an early follow-up appointment prior to discharge

About half of Medicare patients with these conditions are readmitted before they’ve even had a postdischarge follow-up appointment. Ideally this should occur within 7 days. The purpose of early follow-up is to identify and address gaps in the discharge plan of care, revise the discharge plan of care to adapt to the outpatient environment, and reinforce critical health behaviors.

Consider and address other comorbidities

Comorbidities are the rule rather than the exception and contribute to many readmissions. Get primary care on the team and enlist their help in managing these issues before they lead to an exacerbation. “Meticulous control – even perfect control were it possible – of cardiopulmonary disease would still leave patients vulnerable to significant risk of readmission from other causes.”

Consider ancillary supportive services at home

Patients may be overwhelmed by the complexity of postdischarge care. Home health assistance can help in getting patients to physical therapy, continuing patient education, and providing a home clinical assessment.

Neither of the authors had any financial disclosures.

msullivan@mdedge.com

Patients with both chronic obstructive pulmonary disease (COPD) and heart failure (HF) are prone to hospital readmissions that detract from quality of life and dramatically drive up care costs.

Because the two chronic diseases spring from the same root cause and share overlapping symptoms, strategies that improve clinical outcomes in one can also benefit the other, Ravi Kalhan, MD, and R. Kannan Mutharasan, MD, wrote in CHEST Journal (doi: 10.1016/j.chest.2018.06.001).

“Both conditions are characterized by periods of clinical stability punctuated by episodes of exacerbation and are typified by gradual functional decline,” wrote the colleagues, both of Northwestern University, Chicago. “From a patient perspective, both conditions lead to highly overlapping patterns of symptoms, involve complicated medication regimens, and have courses highly sensitive to adherence and lifestyle modification. Therefore, disease management strategies for both conditions can be synergistic.”

The team came up with a “Top 10 list” of practical tips for reducing readmissions in patients with this challenging combination.
 

Diagnose accurately

An acute hospitalization is often the first time these patients pop up on the radar. This is a great time to employ spirometry to accurately diagnose COPD. It’s also appropriate to conduct a chest CT and check right heart size, diameter of the pulmonary artery, and the presence of coronary calcification. The authors noted that relatively little is known about the course of patients with combined asthma and HF in contrast to COPD and HF.

Detect admissions for exacerbations early

Check soon to find out if this is a readmission, get an acute plan going, and don’t wait to implement multidisciplinary interventions. “First, specialist involvement can occur more rapidly, allowing for faster identification of any root causes driving the HF or COPD syndromes, and allowing for more rapid institution of treatment plans to control the acute exacerbation. Second, early identification during hospitalization allows time to deploy multidisciplinary interventions, such as disease management education, social work evaluation, follow-up appointment scheduling, and coordination of home services. These interventions are less effective, and are often not implemented, if initiated toward the end of hospitalization.”

Use specialist management in the hospital

Get experts on board fast. An integrated team means a coordinated treatment plan that’s easier to follow and more effective therapeutically. Specialist care may impact rates of readmission: weight loss with diuretics; discharge doses of guideline-directed medical therapy for heart failure; and higher rates of discharge on long-acting beta-agonists, long-acting muscarinic antagonists, inhaled corticosteroids, and home supplemental oxygen.

Modify the underlying disease substrate

Heart failure is more likely to arise from a correctable pathophysiology, so find it early and treat it thoroughly – especially in younger patients. Ischemic heart disease, valvular heart disease, systemic hypertension, and pulmonary hypertension all have potential to make the HF syndrome more tractable.

Apply and intensify evidence-based therapies

Start in the hospital if possible; if not, begin upon discharge. “The order of application of these therapies can be bewildering, as many strategies for initiation and up-titration of these medications are reasonable. Not only are there long-term outcome benefits for these therapies, evidence suggests early initiation of HF therapies can reduce 30-day readmissions.”

Activate the patient and develop critical health behaviors

Medical regimens for these diseases can be complex, and they must be supported by patient engagement. “Many strategies for engaging patients in care have been tested, including teaching to goal, motivational interviewing, and teach-back methods of activation and engagement. Often these methods are time intensive. Because physician time is increasingly constrained, a team approach is particularly useful.”

Set up feedback loops

“Course correction should the patient decompensate is critically important to maintaining outpatient success. Feedback loops can allow for clinical stabilization before rehospitalization is necessary.” Self-monitoring with individually set benchmarks is critical.

Arrange an early follow-up appointment prior to discharge

About half of Medicare patients with these conditions are readmitted before they’ve even had a postdischarge follow-up appointment. Ideally this should occur within 7 days. The purpose of early follow-up is to identify and address gaps in the discharge plan of care, revise the discharge plan of care to adapt to the outpatient environment, and reinforce critical health behaviors.

Consider and address other comorbidities

Comorbidities are the rule rather than the exception and contribute to many readmissions. Get primary care on the team and enlist their help in managing these issues before they lead to an exacerbation. “Meticulous control – even perfect control were it possible – of cardiopulmonary disease would still leave patients vulnerable to significant risk of readmission from other causes.”

Consider ancillary supportive services at home

Patients may be overwhelmed by the complexity of postdischarge care. Home health assistance can help in getting patients to physical therapy, continuing patient education, and providing a home clinical assessment.

Neither of the authors had any financial disclosures.

msullivan@mdedge.com

Patients with both chronic obstructive pulmonary disease (COPD) and heart failure (HF) are prone to hospital readmissions that detract from quality of life and dramatically drive up care costs.

Because the two chronic diseases spring from the same root cause and share overlapping symptoms, strategies that improve clinical outcomes in one can also benefit the other, Ravi Kalhan, MD, and R. Kannan Mutharasan, MD, wrote in CHEST Journal (doi: 10.1016/j.chest.2018.06.001).

“Both conditions are characterized by periods of clinical stability punctuated by episodes of exacerbation and are typified by gradual functional decline,” wrote the colleagues, both of Northwestern University, Chicago. “From a patient perspective, both conditions lead to highly overlapping patterns of symptoms, involve complicated medication regimens, and have courses highly sensitive to adherence and lifestyle modification. Therefore, disease management strategies for both conditions can be synergistic.”

The team came up with a “Top 10 list” of practical tips for reducing readmissions in patients with this challenging combination.
 

Diagnose accurately

An acute hospitalization is often the first time these patients pop up on the radar. This is a great time to employ spirometry to accurately diagnose COPD. It’s also appropriate to conduct a chest CT and check right heart size, diameter of the pulmonary artery, and the presence of coronary calcification. The authors noted that relatively little is known about the course of patients with combined asthma and HF in contrast to COPD and HF.

Detect admissions for exacerbations early

Check soon to find out if this is a readmission, get an acute plan going, and don’t wait to implement multidisciplinary interventions. “First, specialist involvement can occur more rapidly, allowing for faster identification of any root causes driving the HF or COPD syndromes, and allowing for more rapid institution of treatment plans to control the acute exacerbation. Second, early identification during hospitalization allows time to deploy multidisciplinary interventions, such as disease management education, social work evaluation, follow-up appointment scheduling, and coordination of home services. These interventions are less effective, and are often not implemented, if initiated toward the end of hospitalization.”

Use specialist management in the hospital

Get experts on board fast. An integrated team means a coordinated treatment plan that’s easier to follow and more effective therapeutically. Specialist care may impact rates of readmission: weight loss with diuretics; discharge doses of guideline-directed medical therapy for heart failure; and higher rates of discharge on long-acting beta-agonists, long-acting muscarinic antagonists, inhaled corticosteroids, and home supplemental oxygen.

Modify the underlying disease substrate

Heart failure is more likely to arise from a correctable pathophysiology, so find it early and treat it thoroughly – especially in younger patients. Ischemic heart disease, valvular heart disease, systemic hypertension, and pulmonary hypertension all have potential to make the HF syndrome more tractable.

Apply and intensify evidence-based therapies

Start in the hospital if possible; if not, begin upon discharge. “The order of application of these therapies can be bewildering, as many strategies for initiation and up-titration of these medications are reasonable. Not only are there long-term outcome benefits for these therapies, evidence suggests early initiation of HF therapies can reduce 30-day readmissions.”

Activate the patient and develop critical health behaviors

Medical regimens for these diseases can be complex, and they must be supported by patient engagement. “Many strategies for engaging patients in care have been tested, including teaching to goal, motivational interviewing, and teach-back methods of activation and engagement. Often these methods are time intensive. Because physician time is increasingly constrained, a team approach is particularly useful.”

Set up feedback loops

“Course correction should the patient decompensate is critically important to maintaining outpatient success. Feedback loops can allow for clinical stabilization before rehospitalization is necessary.” Self-monitoring with individually set benchmarks is critical.

Arrange an early follow-up appointment prior to discharge

About half of Medicare patients with these conditions are readmitted before they’ve even had a postdischarge follow-up appointment. Ideally this should occur within 7 days. The purpose of early follow-up is to identify and address gaps in the discharge plan of care, revise the discharge plan of care to adapt to the outpatient environment, and reinforce critical health behaviors.

Consider and address other comorbidities

Comorbidities are the rule rather than the exception and contribute to many readmissions. Get primary care on the team and enlist their help in managing these issues before they lead to an exacerbation. “Meticulous control – even perfect control were it possible – of cardiopulmonary disease would still leave patients vulnerable to significant risk of readmission from other causes.”

Consider ancillary supportive services at home

Patients may be overwhelmed by the complexity of postdischarge care. Home health assistance can help in getting patients to physical therapy, continuing patient education, and providing a home clinical assessment.

Neither of the authors had any financial disclosures.

msullivan@mdedge.com

Participation in Medicare’s bundled payments initiative didn’t significantly change payments per episode or care outcomes for the top five medical conditions selected under the program, a new analysis shows.

Payments for the common conditions remained around $24,000 per episode before and during participation in the Bundled Payments for Care Improvement (BPCI) initiative for the 125 participating hospitals evaluated in this study, conducted by Karen E. Joynt Maddox, MD, of Washington University, St. Louis, and her coauthors.

The finding contrasts with a previous study showing that hospitals in BPCI successfully lowered overall Medicare payments for patients who underwent joint replacement.

“Bundling of services to encourage more efficient care has great face validity and enjoys bipartisan support,” Dr. Joynt Maddox and her colleagues wrote. “For such bundling to work for medical conditions, however, more time, new care strategies and partnerships, or additional incentives may be required.”

The Center for Medicare & Medicaid Innovation initiated the voluntary BPCI demonstration project in 2013. The program targets 48 conditions that account for about 70% of Medicare spending. Hospitals that achieve cost targets for a specific condition get to keep a portion of the savings, and they reimburse Medicare for part of the difference when costs are exceeded.

The present study focused on 2013-2015 Medicare claims for the five medical conditions that account for two-thirds of patients enrolled in medical bundles: congestive heart failure, pneumonia, chronic obstructive pulmonary disease, sepsis, and acute myocardial infarction.

Mean baseline payments per episode for those conditions were $24,280 before participation in the BPCI. After hospitals joined, their average payments per episode were $23,993 (P = .41). For a set of matched control hospitals, payments were a mean of $23,901 at baseline and $23,503 in the corresponding follow-up period (P = .08).

That amounted to a $286 payment reduction for BPCI hospitals and a $398 reduction for controls, a difference of $112 (P = .79), the study investigators reported.

Changes in length of stay, readmissions, emergency department use, and clinical complexity of cases from baseline to follow-up periods was not significantly different between BPCI and control hospitals. For example, 90-day mortality increases were seen in both groups, and the degree of increase was not statistically different between the groups.

Those data help fill a gap in research on the BPCI program and BPCI Advanced, a related version of the demonstration project that will have its first cohort of participants starting Oct. 1, 2018.

“Despite the importance of episode-based payment, there has been little research examining its efficacy or determining whether it has unintended consequences, such as hospitals’ selecting patients with relatively less complex conditions to reduce costs and improve outcomes,” Dr. Joynt Maddox and her colleagues cautioned.

It’s unclear why the previous joint replacement study showed a successful reduction in costs under BPCI, while the new study did not. However, patients in the new analysis of the most common bundled conditions were older and had higher rates of poverty and disability.

“As a result of these complexities, patients admitted for medical conditions may have had post-acute care needs that were less amenable to intervention,” Dr. Joynt Maddox said.

The investigators added that hospitals’ lack of effective influence on post–acute-care services may blunt their ability to achieve greater savings under BPCI. Better relationships with skilled nursing facilities, long-term care hospitals, home health agencies, and inpatient rehabilitation facilities could make a difference.

The Commonwealth Fund supported the study. One study author reported personal fees from HHS outside the submitted work, and another reported that he is an associate editor for the New England Journal of Medicine. No other disclosures were reported.

SOURCE: Joynt Maddox KE et al. N Engl J Med. 2018 Jul 19;379(3):260-9.

Participation in Medicare’s bundled payments initiative didn’t significantly change payments per episode or care outcomes for the top five medical conditions selected under the program, a new analysis shows.

Payments for the common conditions remained around $24,000 per episode before and during participation in the Bundled Payments for Care Improvement (BPCI) initiative for the 125 participating hospitals evaluated in this study, conducted by Karen E. Joynt Maddox, MD, of Washington University, St. Louis, and her coauthors.

The finding contrasts with a previous study showing that hospitals in BPCI successfully lowered overall Medicare payments for patients who underwent joint replacement.

“Bundling of services to encourage more efficient care has great face validity and enjoys bipartisan support,” Dr. Joynt Maddox and her colleagues wrote. “For such bundling to work for medical conditions, however, more time, new care strategies and partnerships, or additional incentives may be required.”

The Center for Medicare & Medicaid Innovation initiated the voluntary BPCI demonstration project in 2013. The program targets 48 conditions that account for about 70% of Medicare spending. Hospitals that achieve cost targets for a specific condition get to keep a portion of the savings, and they reimburse Medicare for part of the difference when costs are exceeded.

The present study focused on 2013-2015 Medicare claims for the five medical conditions that account for two-thirds of patients enrolled in medical bundles: congestive heart failure, pneumonia, chronic obstructive pulmonary disease, sepsis, and acute myocardial infarction.

Mean baseline payments per episode for those conditions were $24,280 before participation in the BPCI. After hospitals joined, their average payments per episode were $23,993 (P = .41). For a set of matched control hospitals, payments were a mean of $23,901 at baseline and $23,503 in the corresponding follow-up period (P = .08).

That amounted to a $286 payment reduction for BPCI hospitals and a $398 reduction for controls, a difference of $112 (P = .79), the study investigators reported.

Changes in length of stay, readmissions, emergency department use, and clinical complexity of cases from baseline to follow-up periods was not significantly different between BPCI and control hospitals. For example, 90-day mortality increases were seen in both groups, and the degree of increase was not statistically different between the groups.

Those data help fill a gap in research on the BPCI program and BPCI Advanced, a related version of the demonstration project that will have its first cohort of participants starting Oct. 1, 2018.

“Despite the importance of episode-based payment, there has been little research examining its efficacy or determining whether it has unintended consequences, such as hospitals’ selecting patients with relatively less complex conditions to reduce costs and improve outcomes,” Dr. Joynt Maddox and her colleagues cautioned.

It’s unclear why the previous joint replacement study showed a successful reduction in costs under BPCI, while the new study did not. However, patients in the new analysis of the most common bundled conditions were older and had higher rates of poverty and disability.

“As a result of these complexities, patients admitted for medical conditions may have had post-acute care needs that were less amenable to intervention,” Dr. Joynt Maddox said.

The investigators added that hospitals’ lack of effective influence on post–acute-care services may blunt their ability to achieve greater savings under BPCI. Better relationships with skilled nursing facilities, long-term care hospitals, home health agencies, and inpatient rehabilitation facilities could make a difference.

The Commonwealth Fund supported the study. One study author reported personal fees from HHS outside the submitted work, and another reported that he is an associate editor for the New England Journal of Medicine. No other disclosures were reported.

SOURCE: Joynt Maddox KE et al. N Engl J Med. 2018 Jul 19;379(3):260-9.

Participation in Medicare’s bundled payments initiative didn’t significantly change payments per episode or care outcomes for the top five medical conditions selected under the program, a new analysis shows.

Payments for the common conditions remained around $24,000 per episode before and during participation in the Bundled Payments for Care Improvement (BPCI) initiative for the 125 participating hospitals evaluated in this study, conducted by Karen E. Joynt Maddox, MD, of Washington University, St. Louis, and her coauthors.

The finding contrasts with a previous study showing that hospitals in BPCI successfully lowered overall Medicare payments for patients who underwent joint replacement.

“Bundling of services to encourage more efficient care has great face validity and enjoys bipartisan support,” Dr. Joynt Maddox and her colleagues wrote. “For such bundling to work for medical conditions, however, more time, new care strategies and partnerships, or additional incentives may be required.”

The Center for Medicare & Medicaid Innovation initiated the voluntary BPCI demonstration project in 2013. The program targets 48 conditions that account for about 70% of Medicare spending. Hospitals that achieve cost targets for a specific condition get to keep a portion of the savings, and they reimburse Medicare for part of the difference when costs are exceeded.

The present study focused on 2013-2015 Medicare claims for the five medical conditions that account for two-thirds of patients enrolled in medical bundles: congestive heart failure, pneumonia, chronic obstructive pulmonary disease, sepsis, and acute myocardial infarction.

Mean baseline payments per episode for those conditions were $24,280 before participation in the BPCI. After hospitals joined, their average payments per episode were $23,993 (P = .41). For a set of matched control hospitals, payments were a mean of $23,901 at baseline and $23,503 in the corresponding follow-up period (P = .08).

That amounted to a $286 payment reduction for BPCI hospitals and a $398 reduction for controls, a difference of $112 (P = .79), the study investigators reported.

Changes in length of stay, readmissions, emergency department use, and clinical complexity of cases from baseline to follow-up periods was not significantly different between BPCI and control hospitals. For example, 90-day mortality increases were seen in both groups, and the degree of increase was not statistically different between the groups.

Those data help fill a gap in research on the BPCI program and BPCI Advanced, a related version of the demonstration project that will have its first cohort of participants starting Oct. 1, 2018.

“Despite the importance of episode-based payment, there has been little research examining its efficacy or determining whether it has unintended consequences, such as hospitals’ selecting patients with relatively less complex conditions to reduce costs and improve outcomes,” Dr. Joynt Maddox and her colleagues cautioned.

It’s unclear why the previous joint replacement study showed a successful reduction in costs under BPCI, while the new study did not. However, patients in the new analysis of the most common bundled conditions were older and had higher rates of poverty and disability.

“As a result of these complexities, patients admitted for medical conditions may have had post-acute care needs that were less amenable to intervention,” Dr. Joynt Maddox said.

The investigators added that hospitals’ lack of effective influence on post–acute-care services may blunt their ability to achieve greater savings under BPCI. Better relationships with skilled nursing facilities, long-term care hospitals, home health agencies, and inpatient rehabilitation facilities could make a difference.

The Commonwealth Fund supported the study. One study author reported personal fees from HHS outside the submitted work, and another reported that he is an associate editor for the New England Journal of Medicine. No other disclosures were reported.

SOURCE: Joynt Maddox KE et al. N Engl J Med. 2018 Jul 19;379(3):260-9.

A 2005 update in Medicare reimbursement policy had a modest effect on the use of implantable cardioverter defibrillators for primary prevention, but it took a whistle-blower and a federal lawsuit to bring the numbers down substantially.

Usage dropped just slightly from 2007 to 2009, after Medicare updated its appropriate use criteria, Nihar R. Desai, MD, MPH, and his colleagues reported in JAMA. From 2010 to 2011, after the Department of Justice suit became public knowledge, the declines were significantly greater: 7.4% in hospitals that eventually settled for a total of $280 million, and 4.7% in hospitals that weren’t named in the suit.

The government launched the suit in 2010, after a whistle-blower used Medicare data to allege that many hospitals weren’t waiting the appropriate amount of time to implant an implantable cardioverter defibrillator (ICD) after a heart attack or coronary revascularization, wrote Dr. Desai of Yale University, New Haven, Conn., and his team. These procedures would have been against the 2005 Centers for Medicare & Medicaid Services National Coverage Determination (NCD), which required delaying implantation for 40 days after a heart attack and 90 days after a revascularization.

Just a year after the suit was filed, an independent investigator concluded that 22.5% of the ICDs implanted from 2006 to 2009 for primary prevention were not evidence based.

Dr. Desai and his coauthors used CMS data to examine changes in the proportion of primary-prevention ICD implantations at hospitals that eventually settled the suit, and those that did not. The study spanned 2007-2015 and comprised 1,809 U.S. hospitals in the National Cardiovascular Data Registry ICD Registry; of these, 452 hospitals that had done 99,591 procedures reached settlements.

After the steeper drops in 2010 and 2011, the number of procedures leveled off. From July 2011 to 2015, the proportions of ICDs not meeting the NCD criteria were similar and stable in both hospital settlement groups, with an annual change of −0.5% for settlement hospitals and −0.4% for nonsettlement hospitals, the team wrote.

Despite the changes, there was “persistent variation” among hospitals, with more than 14% of the primary-prevention ICDs not meeting NCD criteria at some of the worst-performing hospitals.

The decreases weren’t just in Medicare beneficiaries, though. Hospitals were rethinking this indication for ICD use in everyone, although the investigators found no evidence that the changing clinical landscape endangered the health of patients.

“The analyses of secondary prevention ICDs do not suggest that access to necessary procedures was negatively affected by the investigation. … These analyses offer some reassurance, but further research into hospital responses to the investigation could offer additional insights about possible unintended consequences,” the investigators wrote.

The study was sponsored by the Agency for Healthcare Research and Quality. Dr. Desai had no financial disclosures.

msullivan@mdedge.com

SOURCE: Desai NR et al. JAMA. 2018; 320: 63-71.

A 2005 update in Medicare reimbursement policy had a modest effect on the use of implantable cardioverter defibrillators for primary prevention, but it took a whistle-blower and a federal lawsuit to bring the numbers down substantially.

Usage dropped just slightly from 2007 to 2009, after Medicare updated its appropriate use criteria, Nihar R. Desai, MD, MPH, and his colleagues reported in JAMA. From 2010 to 2011, after the Department of Justice suit became public knowledge, the declines were significantly greater: 7.4% in hospitals that eventually settled for a total of $280 million, and 4.7% in hospitals that weren’t named in the suit.

The government launched the suit in 2010, after a whistle-blower used Medicare data to allege that many hospitals weren’t waiting the appropriate amount of time to implant an implantable cardioverter defibrillator (ICD) after a heart attack or coronary revascularization, wrote Dr. Desai of Yale University, New Haven, Conn., and his team. These procedures would have been against the 2005 Centers for Medicare & Medicaid Services National Coverage Determination (NCD), which required delaying implantation for 40 days after a heart attack and 90 days after a revascularization.

Just a year after the suit was filed, an independent investigator concluded that 22.5% of the ICDs implanted from 2006 to 2009 for primary prevention were not evidence based.

Dr. Desai and his coauthors used CMS data to examine changes in the proportion of primary-prevention ICD implantations at hospitals that eventually settled the suit, and those that did not. The study spanned 2007-2015 and comprised 1,809 U.S. hospitals in the National Cardiovascular Data Registry ICD Registry; of these, 452 hospitals that had done 99,591 procedures reached settlements.

After the steeper drops in 2010 and 2011, the number of procedures leveled off. From July 2011 to 2015, the proportions of ICDs not meeting the NCD criteria were similar and stable in both hospital settlement groups, with an annual change of −0.5% for settlement hospitals and −0.4% for nonsettlement hospitals, the team wrote.

Despite the changes, there was “persistent variation” among hospitals, with more than 14% of the primary-prevention ICDs not meeting NCD criteria at some of the worst-performing hospitals.

The decreases weren’t just in Medicare beneficiaries, though. Hospitals were rethinking this indication for ICD use in everyone, although the investigators found no evidence that the changing clinical landscape endangered the health of patients.

“The analyses of secondary prevention ICDs do not suggest that access to necessary procedures was negatively affected by the investigation. … These analyses offer some reassurance, but further research into hospital responses to the investigation could offer additional insights about possible unintended consequences,” the investigators wrote.

The study was sponsored by the Agency for Healthcare Research and Quality. Dr. Desai had no financial disclosures.

msullivan@mdedge.com

SOURCE: Desai NR et al. JAMA. 2018; 320: 63-71.

A 2005 update in Medicare reimbursement policy had a modest effect on the use of implantable cardioverter defibrillators for primary prevention, but it took a whistle-blower and a federal lawsuit to bring the numbers down substantially.

Usage dropped just slightly from 2007 to 2009, after Medicare updated its appropriate use criteria, Nihar R. Desai, MD, MPH, and his colleagues reported in JAMA. From 2010 to 2011, after the Department of Justice suit became public knowledge, the declines were significantly greater: 7.4% in hospitals that eventually settled for a total of $280 million, and 4.7% in hospitals that weren’t named in the suit.

The government launched the suit in 2010, after a whistle-blower used Medicare data to allege that many hospitals weren’t waiting the appropriate amount of time to implant an implantable cardioverter defibrillator (ICD) after a heart attack or coronary revascularization, wrote Dr. Desai of Yale University, New Haven, Conn., and his team. These procedures would have been against the 2005 Centers for Medicare & Medicaid Services National Coverage Determination (NCD), which required delaying implantation for 40 days after a heart attack and 90 days after a revascularization.

Just a year after the suit was filed, an independent investigator concluded that 22.5% of the ICDs implanted from 2006 to 2009 for primary prevention were not evidence based.

Dr. Desai and his coauthors used CMS data to examine changes in the proportion of primary-prevention ICD implantations at hospitals that eventually settled the suit, and those that did not. The study spanned 2007-2015 and comprised 1,809 U.S. hospitals in the National Cardiovascular Data Registry ICD Registry; of these, 452 hospitals that had done 99,591 procedures reached settlements.

After the steeper drops in 2010 and 2011, the number of procedures leveled off. From July 2011 to 2015, the proportions of ICDs not meeting the NCD criteria were similar and stable in both hospital settlement groups, with an annual change of −0.5% for settlement hospitals and −0.4% for nonsettlement hospitals, the team wrote.

Despite the changes, there was “persistent variation” among hospitals, with more than 14% of the primary-prevention ICDs not meeting NCD criteria at some of the worst-performing hospitals.

The decreases weren’t just in Medicare beneficiaries, though. Hospitals were rethinking this indication for ICD use in everyone, although the investigators found no evidence that the changing clinical landscape endangered the health of patients.

“The analyses of secondary prevention ICDs do not suggest that access to necessary procedures was negatively affected by the investigation. … These analyses offer some reassurance, but further research into hospital responses to the investigation could offer additional insights about possible unintended consequences,” the investigators wrote.

The study was sponsored by the Agency for Healthcare Research and Quality. Dr. Desai had no financial disclosures.

msullivan@mdedge.com

SOURCE: Desai NR et al. JAMA. 2018; 320: 63-71.

AMSTERDAM – The combination of heart failure and rheumatoid arthritis carries a poor prognosis, according to data from the German biologics register.

Of 393 patients enrolled in RABBIT (Rheumatoide Arthritis: Beobachtung der Biologika-Therapie) who had heart failure in addition to their rheumatoid arthritis, 131 (33%) needed hospital treatment or died over a 10-year period. The mean time to hospitalization or death was 2.5-3.0 years.

Sara Freeman/MDEdge

“There is still not enough known about this topic, and we need the research to determine how to best manage these patients,” Dr. Meissner said. “The time to an event was only 3 years from the time of inclusion in the register, so we need better management of those patients with heart failure as a comorbidity.”

RABBIT is supported by a joint, unconditional grant from AbbVie, Bristol-Myers Squibb, Celltrion, Hexal AG, Lilly, MSD Sharp & Dohme, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, and UCB. Dr. Meissner disclosed being on a speakers bureau for Pfizer.

SOURCE: Meissner Y et al. EULAR 2018 Congress. Abstract THU0142 .
 

AMSTERDAM – The combination of heart failure and rheumatoid arthritis carries a poor prognosis, according to data from the German biologics register.

Of 393 patients enrolled in RABBIT (Rheumatoide Arthritis: Beobachtung der Biologika-Therapie) who had heart failure in addition to their rheumatoid arthritis, 131 (33%) needed hospital treatment or died over a 10-year period. The mean time to hospitalization or death was 2.5-3.0 years.

Sara Freeman/MDEdge

“There is still not enough known about this topic, and we need the research to determine how to best manage these patients,” Dr. Meissner said. “The time to an event was only 3 years from the time of inclusion in the register, so we need better management of those patients with heart failure as a comorbidity.”

RABBIT is supported by a joint, unconditional grant from AbbVie, Bristol-Myers Squibb, Celltrion, Hexal AG, Lilly, MSD Sharp & Dohme, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, and UCB. Dr. Meissner disclosed being on a speakers bureau for Pfizer.

SOURCE: Meissner Y et al. EULAR 2018 Congress. Abstract THU0142 .
 

AMSTERDAM – The combination of heart failure and rheumatoid arthritis carries a poor prognosis, according to data from the German biologics register.

Of 393 patients enrolled in RABBIT (Rheumatoide Arthritis: Beobachtung der Biologika-Therapie) who had heart failure in addition to their rheumatoid arthritis, 131 (33%) needed hospital treatment or died over a 10-year period. The mean time to hospitalization or death was 2.5-3.0 years.

Sara Freeman/MDEdge

“There is still not enough known about this topic, and we need the research to determine how to best manage these patients,” Dr. Meissner said. “The time to an event was only 3 years from the time of inclusion in the register, so we need better management of those patients with heart failure as a comorbidity.”

RABBIT is supported by a joint, unconditional grant from AbbVie, Bristol-Myers Squibb, Celltrion, Hexal AG, Lilly, MSD Sharp & Dohme, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, and UCB. Dr. Meissner disclosed being on a speakers bureau for Pfizer.

SOURCE: Meissner Y et al. EULAR 2018 Congress. Abstract THU0142 .
 

ORLANDO – An elevated circulating galactin-3 level after an acute MI is a potent long-term predictor of both heart failure and mortality, independent of known prognostic markers, Rabea Asleh, MD, PhD, reported at the annual meeting of the American College of Cardiology.

“These findings suggest that galectin-3 measurement may have a role in the risk stratification of patients presenting with MI,” according to Dr. Asleh, an Israeli cardiologist doing a fellowship in advanced heart failure and transplant cardiology at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/MDedge News

bjancin@mdedge.com

ORLANDO – An elevated circulating galactin-3 level after an acute MI is a potent long-term predictor of both heart failure and mortality, independent of known prognostic markers, Rabea Asleh, MD, PhD, reported at the annual meeting of the American College of Cardiology.

“These findings suggest that galectin-3 measurement may have a role in the risk stratification of patients presenting with MI,” according to Dr. Asleh, an Israeli cardiologist doing a fellowship in advanced heart failure and transplant cardiology at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/MDedge News

bjancin@mdedge.com

ORLANDO – An elevated circulating galactin-3 level after an acute MI is a potent long-term predictor of both heart failure and mortality, independent of known prognostic markers, Rabea Asleh, MD, PhD, reported at the annual meeting of the American College of Cardiology.

“These findings suggest that galectin-3 measurement may have a role in the risk stratification of patients presenting with MI,” according to Dr. Asleh, an Israeli cardiologist doing a fellowship in advanced heart failure and transplant cardiology at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/MDedge News

bjancin@mdedge.com

PARIS – Follow-up data from a randomized trial of transcatheter versus surgical aortic valve replacement in low-surgical-risk patients with symptomatic severe aortic stenosis showed sustained superior hemodynamic valve performance and less structural valve deterioration in the transcatheter group through 6 years, Lars Sondergaard, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Moreover, the rate of bioprosthetic valve failure as formally defined in a recent European consensus statement (Eur Heart J. 2017 Dec 1;38[45]:3382-90) was similarly low in the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) arms at about 7%, in the randomized study known as NOTION (Nordic Aortic Valve Intervention), added Dr. Sondergaard, professor of cardiology at the University of Copenhagen, who was a coauthor of the consensus statement.

Bruce Jancin/MDedge News

The rate of moderate hemodynamic structural valve deterioration through 6 years of follow-up was 3.6% in the TAVR arm, compared with 23.7% in the SAVR group. The rate of nonstructural valve deterioration was 54.0% with TAVR and 57.8% with SAVR, and there were no cases of moderate or severe aortic regurgitation in either group.

The mean aortic valve gradient in the TAVR group went from 44.9 mm Hg at baseline to 12.2 mm Hg at 3 months and to 14.7 mm Hg at 6 years. In the SAVR group, the figures were 44.9 mm Hg, 8.3 mm Hg, and 9.9 mm Hg, respectively.

The effective orifice area in the TAVR group improved from 0.74 cm² at baseline to 1.37 cm² at 3 months and to 1.16 cm² at 6 years. With SAVR, the effective orifice area was 0.74 cm² at baseline, 1.66 cm² at 3 months, and 1.53 cm² at 6 years.

Through 6 years of follow-up, there were no cases of thrombosis in either study arm, and the rate of endocarditis was just under 6% in each group through 6 years. All-cause mortality through 6 years was 42.5% in the TAVR group, not significantly different from the 37.7% rate in the SAVR arm.

The valve-related death rate was 5.0% in the TAVR arm and similar at 3.7% with SAVR. Reintervention occurred in 2.2% of TAVR patients and in 0.7% of SAVR patients. Severe hemodynamic structural valve deterioration was documented in 0.7% of TAVR patients and 3.0% of SAVR patients. The overall rate of bioprosthetic valve failure – a composite of these three endpoints – was 7.5% with TAVR and similar at 6.7% with SAVR.

Session cochair Alain G. Cribier, MD, a TAVR pioneer who is professor of medicine and director of cardiology at Charles Nicolle Hospital, University of Rouen (France), declared, “This is extremely encouraging.”

However, discussant Corrado Tamburino, MD, was more circumspect.

bjancin@mdedge.com

PARIS – Follow-up data from a randomized trial of transcatheter versus surgical aortic valve replacement in low-surgical-risk patients with symptomatic severe aortic stenosis showed sustained superior hemodynamic valve performance and less structural valve deterioration in the transcatheter group through 6 years, Lars Sondergaard, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Moreover, the rate of bioprosthetic valve failure as formally defined in a recent European consensus statement (Eur Heart J. 2017 Dec 1;38[45]:3382-90) was similarly low in the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) arms at about 7%, in the randomized study known as NOTION (Nordic Aortic Valve Intervention), added Dr. Sondergaard, professor of cardiology at the University of Copenhagen, who was a coauthor of the consensus statement.

Bruce Jancin/MDedge News

The rate of moderate hemodynamic structural valve deterioration through 6 years of follow-up was 3.6% in the TAVR arm, compared with 23.7% in the SAVR group. The rate of nonstructural valve deterioration was 54.0% with TAVR and 57.8% with SAVR, and there were no cases of moderate or severe aortic regurgitation in either group.

The mean aortic valve gradient in the TAVR group went from 44.9 mm Hg at baseline to 12.2 mm Hg at 3 months and to 14.7 mm Hg at 6 years. In the SAVR group, the figures were 44.9 mm Hg, 8.3 mm Hg, and 9.9 mm Hg, respectively.

The effective orifice area in the TAVR group improved from 0.74 cm² at baseline to 1.37 cm² at 3 months and to 1.16 cm² at 6 years. With SAVR, the effective orifice area was 0.74 cm² at baseline, 1.66 cm² at 3 months, and 1.53 cm² at 6 years.

Through 6 years of follow-up, there were no cases of thrombosis in either study arm, and the rate of endocarditis was just under 6% in each group through 6 years. All-cause mortality through 6 years was 42.5% in the TAVR group, not significantly different from the 37.7% rate in the SAVR arm.

The valve-related death rate was 5.0% in the TAVR arm and similar at 3.7% with SAVR. Reintervention occurred in 2.2% of TAVR patients and in 0.7% of SAVR patients. Severe hemodynamic structural valve deterioration was documented in 0.7% of TAVR patients and 3.0% of SAVR patients. The overall rate of bioprosthetic valve failure – a composite of these three endpoints – was 7.5% with TAVR and similar at 6.7% with SAVR.

Session cochair Alain G. Cribier, MD, a TAVR pioneer who is professor of medicine and director of cardiology at Charles Nicolle Hospital, University of Rouen (France), declared, “This is extremely encouraging.”

However, discussant Corrado Tamburino, MD, was more circumspect.

bjancin@mdedge.com

PARIS – Follow-up data from a randomized trial of transcatheter versus surgical aortic valve replacement in low-surgical-risk patients with symptomatic severe aortic stenosis showed sustained superior hemodynamic valve performance and less structural valve deterioration in the transcatheter group through 6 years, Lars Sondergaard, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Moreover, the rate of bioprosthetic valve failure as formally defined in a recent European consensus statement (Eur Heart J. 2017 Dec 1;38[45]:3382-90) was similarly low in the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) arms at about 7%, in the randomized study known as NOTION (Nordic Aortic Valve Intervention), added Dr. Sondergaard, professor of cardiology at the University of Copenhagen, who was a coauthor of the consensus statement.

Bruce Jancin/MDedge News

The rate of moderate hemodynamic structural valve deterioration through 6 years of follow-up was 3.6% in the TAVR arm, compared with 23.7% in the SAVR group. The rate of nonstructural valve deterioration was 54.0% with TAVR and 57.8% with SAVR, and there were no cases of moderate or severe aortic regurgitation in either group.

The mean aortic valve gradient in the TAVR group went from 44.9 mm Hg at baseline to 12.2 mm Hg at 3 months and to 14.7 mm Hg at 6 years. In the SAVR group, the figures were 44.9 mm Hg, 8.3 mm Hg, and 9.9 mm Hg, respectively.

The effective orifice area in the TAVR group improved from 0.74 cm² at baseline to 1.37 cm² at 3 months and to 1.16 cm² at 6 years. With SAVR, the effective orifice area was 0.74 cm² at baseline, 1.66 cm² at 3 months, and 1.53 cm² at 6 years.

Through 6 years of follow-up, there were no cases of thrombosis in either study arm, and the rate of endocarditis was just under 6% in each group through 6 years. All-cause mortality through 6 years was 42.5% in the TAVR group, not significantly different from the 37.7% rate in the SAVR arm.

The valve-related death rate was 5.0% in the TAVR arm and similar at 3.7% with SAVR. Reintervention occurred in 2.2% of TAVR patients and in 0.7% of SAVR patients. Severe hemodynamic structural valve deterioration was documented in 0.7% of TAVR patients and 3.0% of SAVR patients. The overall rate of bioprosthetic valve failure – a composite of these three endpoints – was 7.5% with TAVR and similar at 6.7% with SAVR.

Session cochair Alain G. Cribier, MD, a TAVR pioneer who is professor of medicine and director of cardiology at Charles Nicolle Hospital, University of Rouen (France), declared, “This is extremely encouraging.”

However, discussant Corrado Tamburino, MD, was more circumspect.

bjancin@mdedge.com

BOSTON – About half of patients who present with a new onset of frequent premature ventricular contractions without obvious underlying heart disease had an underlying myocardial inflammation that was often responsive to immunosuppressive treatment, according to a single-center series of 107 patients.

“Early diagnosis and appropriate treatment with immunosuppressive therapy can significantly affect the clinical course,” although large-scale, multicenter, randomized trials must confirm this as an effective management approach, Dhanunjaya Lakkireddy, MD, said at the annual scientific sessions of the Heart Rhythm Society. He stressed that the anecdotal efficacy seen in this series with immunosuppressive therapy and selected use of ablation treatment for the premature ventricular contractions (PVCs) applies only to patients with new-onset PVCs that occur at a rate of at least 5,000 during 24 hours who also have myocardial inflammation identified by a PET scan showing increased fluorodeoxyglucose (FDG) uptake.

Mitchel L. Zoler/MDedge News

The data came from the Myocarditis and Ventricular Arrhythmia (MAVERIC) registry that Dr. Lakkireddy and his associates started because “we began seeing patients referred for ablations without underlying heart disease who had suddenly presented with a lot of PVCs,” he recalled, an observation that led them to systematically study these patients in an “arduous” process that involved several tests. One hundred seven patients met the registry’s inclusion criteria for new onset of frequent PVCs without apparent underlying heart disease, and roughly half of these patients showed clear evidence of myocardial inflammation by FDG and PET imaging. “If the PET is negative, I don’t worry about myocarditis, “ Dr. Lakkireddy said.

The 55 patients with apparent myocarditis on PET imaging, out of the 107 patients examined generally, had lower left ventricular (LV) ejection fractions averaging 46%, compared with 51% among the patients without myocarditis The patients with myocarditis further subdivided into 27 with preserved LV function, with an average ejection fraction of 60%, and 28 with a reduced LV function, with an average ejection fraction of 40%. The researchers saw an optimal response to immunosuppressive therapy in 18 of the 23 patients (78%) with preserved ejection fractions who received this treatment and in 13 of the 24 patients (54%) with diminished LV ejection fractions who got immunosuppressive therapy.

Twenty-eight of the 55 patients with myocarditis on PET imaging underwent a right-sided biopsy during their work-up, and 13 of these 28 biopsies (46%) showed a lymphocytic infiltrate of a type often seen in patients with postviral myocarditis. Seven of the 28 biopsied patients (25%) had completely normal-appearing cardiac tissue.

Dr. Lakkireddy has been a consultant to or has received research support from Biosense Webster, Boehinger Ingelheim, Bristol-Myers Squibb, Estech, Janssen, Pfizer, SentreHeart, and St. Jude.

mzoler@mdedge.com

SOURCE: Lakkireddy D et al. Heart Rhythm 2018, Abstract B-LBCT02-02.
 

BOSTON – About half of patients who present with a new onset of frequent premature ventricular contractions without obvious underlying heart disease had an underlying myocardial inflammation that was often responsive to immunosuppressive treatment, according to a single-center series of 107 patients.

“Early diagnosis and appropriate treatment with immunosuppressive therapy can significantly affect the clinical course,” although large-scale, multicenter, randomized trials must confirm this as an effective management approach, Dhanunjaya Lakkireddy, MD, said at the annual scientific sessions of the Heart Rhythm Society. He stressed that the anecdotal efficacy seen in this series with immunosuppressive therapy and selected use of ablation treatment for the premature ventricular contractions (PVCs) applies only to patients with new-onset PVCs that occur at a rate of at least 5,000 during 24 hours who also have myocardial inflammation identified by a PET scan showing increased fluorodeoxyglucose (FDG) uptake.

Mitchel L. Zoler/MDedge News

The data came from the Myocarditis and Ventricular Arrhythmia (MAVERIC) registry that Dr. Lakkireddy and his associates started because “we began seeing patients referred for ablations without underlying heart disease who had suddenly presented with a lot of PVCs,” he recalled, an observation that led them to systematically study these patients in an “arduous” process that involved several tests. One hundred seven patients met the registry’s inclusion criteria for new onset of frequent PVCs without apparent underlying heart disease, and roughly half of these patients showed clear evidence of myocardial inflammation by FDG and PET imaging. “If the PET is negative, I don’t worry about myocarditis, “ Dr. Lakkireddy said.

The 55 patients with apparent myocarditis on PET imaging, out of the 107 patients examined generally, had lower left ventricular (LV) ejection fractions averaging 46%, compared with 51% among the patients without myocarditis The patients with myocarditis further subdivided into 27 with preserved LV function, with an average ejection fraction of 60%, and 28 with a reduced LV function, with an average ejection fraction of 40%. The researchers saw an optimal response to immunosuppressive therapy in 18 of the 23 patients (78%) with preserved ejection fractions who received this treatment and in 13 of the 24 patients (54%) with diminished LV ejection fractions who got immunosuppressive therapy.

Twenty-eight of the 55 patients with myocarditis on PET imaging underwent a right-sided biopsy during their work-up, and 13 of these 28 biopsies (46%) showed a lymphocytic infiltrate of a type often seen in patients with postviral myocarditis. Seven of the 28 biopsied patients (25%) had completely normal-appearing cardiac tissue.

Dr. Lakkireddy has been a consultant to or has received research support from Biosense Webster, Boehinger Ingelheim, Bristol-Myers Squibb, Estech, Janssen, Pfizer, SentreHeart, and St. Jude.

mzoler@mdedge.com

SOURCE: Lakkireddy D et al. Heart Rhythm 2018, Abstract B-LBCT02-02.
 

BOSTON – About half of patients who present with a new onset of frequent premature ventricular contractions without obvious underlying heart disease had an underlying myocardial inflammation that was often responsive to immunosuppressive treatment, according to a single-center series of 107 patients.

“Early diagnosis and appropriate treatment with immunosuppressive therapy can significantly affect the clinical course,” although large-scale, multicenter, randomized trials must confirm this as an effective management approach, Dhanunjaya Lakkireddy, MD, said at the annual scientific sessions of the Heart Rhythm Society. He stressed that the anecdotal efficacy seen in this series with immunosuppressive therapy and selected use of ablation treatment for the premature ventricular contractions (PVCs) applies only to patients with new-onset PVCs that occur at a rate of at least 5,000 during 24 hours who also have myocardial inflammation identified by a PET scan showing increased fluorodeoxyglucose (FDG) uptake.

Mitchel L. Zoler/MDedge News

The data came from the Myocarditis and Ventricular Arrhythmia (MAVERIC) registry that Dr. Lakkireddy and his associates started because “we began seeing patients referred for ablations without underlying heart disease who had suddenly presented with a lot of PVCs,” he recalled, an observation that led them to systematically study these patients in an “arduous” process that involved several tests. One hundred seven patients met the registry’s inclusion criteria for new onset of frequent PVCs without apparent underlying heart disease, and roughly half of these patients showed clear evidence of myocardial inflammation by FDG and PET imaging. “If the PET is negative, I don’t worry about myocarditis, “ Dr. Lakkireddy said.

The 55 patients with apparent myocarditis on PET imaging, out of the 107 patients examined generally, had lower left ventricular (LV) ejection fractions averaging 46%, compared with 51% among the patients without myocarditis The patients with myocarditis further subdivided into 27 with preserved LV function, with an average ejection fraction of 60%, and 28 with a reduced LV function, with an average ejection fraction of 40%. The researchers saw an optimal response to immunosuppressive therapy in 18 of the 23 patients (78%) with preserved ejection fractions who received this treatment and in 13 of the 24 patients (54%) with diminished LV ejection fractions who got immunosuppressive therapy.

Twenty-eight of the 55 patients with myocarditis on PET imaging underwent a right-sided biopsy during their work-up, and 13 of these 28 biopsies (46%) showed a lymphocytic infiltrate of a type often seen in patients with postviral myocarditis. Seven of the 28 biopsied patients (25%) had completely normal-appearing cardiac tissue.

Dr. Lakkireddy has been a consultant to or has received research support from Biosense Webster, Boehinger Ingelheim, Bristol-Myers Squibb, Estech, Janssen, Pfizer, SentreHeart, and St. Jude.

mzoler@mdedge.com

SOURCE: Lakkireddy D et al. Heart Rhythm 2018, Abstract B-LBCT02-02.
 

BOSTON – Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.

This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).

This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).

In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.

The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.

“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.

Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

mzoler@mdedge.com

BOSTON – Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.

This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).

This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).

In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.

The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.

“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.

Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

mzoler@mdedge.com

BOSTON – Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.

This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).

This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).

In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.

The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.

“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.

Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

mzoler@mdedge.com

The HeartMate 3 left ventricular assist device received a class 1 recall from the Food and Drug Administration on May 17, an action the agency publicly announced on May 22.

The FDA’s step formalized a “corrective action” that the HeartMate 3’s manufacturer, Abbott, first issued in early April and then announced in early May, which said the device used to treat patients with severe advanced heart failure was subject to “outflow graft twist occlusions” that trigger a persistent low-flow alarm and “can result in serious adverse events such as hemodynamic compromise, thrombus, and death,” according to the FDA’s May 17 statement.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The first letter attributed development of these twists in the tube that directs blood out from the device to accumulated mechanical forces from heartbeats, respiration, and activity, and also provided some management guidance that Abbott then expanded in its second letter.

The FDA cited some of the key steps Abbott recommended clinicians take with patients who receive a HeartMate 3. This included regular surveillance with transthoracic echocardiography, although echo is not considered definitive for identifying a graft twist obstruction and hence other investigations may also be needed. If the low-flow alarm sounds, a CT scan is “urgently” needed – as long as it’s not contraindicated – to identify a possible outflow twist. Abbott noted that surgical intervention may be needed to correct a twist.

Researchers recently reported 2-year follow-up data from 257 patients in MOMENTUM 3, the randomized pivotal trial for the HeartMate 3 that compared this fully magnetically levitated centrifugal-flow pump to the prior-generation, axial-flow pump. The composite endpoint of freedom from death, stroke, or need for repeat surgery after 2 years was 80% in the HeartMate 3 recipients and 60% among patients in the control arm who received the older-model device (N Engl J Med. 2018 April 12; 378[15]:1386-95).

mzoler@mdedge.com

The HeartMate 3 left ventricular assist device received a class 1 recall from the Food and Drug Administration on May 17, an action the agency publicly announced on May 22.

The FDA’s step formalized a “corrective action” that the HeartMate 3’s manufacturer, Abbott, first issued in early April and then announced in early May, which said the device used to treat patients with severe advanced heart failure was subject to “outflow graft twist occlusions” that trigger a persistent low-flow alarm and “can result in serious adverse events such as hemodynamic compromise, thrombus, and death,” according to the FDA’s May 17 statement.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The first letter attributed development of these twists in the tube that directs blood out from the device to accumulated mechanical forces from heartbeats, respiration, and activity, and also provided some management guidance that Abbott then expanded in its second letter.

The FDA cited some of the key steps Abbott recommended clinicians take with patients who receive a HeartMate 3. This included regular surveillance with transthoracic echocardiography, although echo is not considered definitive for identifying a graft twist obstruction and hence other investigations may also be needed. If the low-flow alarm sounds, a CT scan is “urgently” needed – as long as it’s not contraindicated – to identify a possible outflow twist. Abbott noted that surgical intervention may be needed to correct a twist.

Researchers recently reported 2-year follow-up data from 257 patients in MOMENTUM 3, the randomized pivotal trial for the HeartMate 3 that compared this fully magnetically levitated centrifugal-flow pump to the prior-generation, axial-flow pump. The composite endpoint of freedom from death, stroke, or need for repeat surgery after 2 years was 80% in the HeartMate 3 recipients and 60% among patients in the control arm who received the older-model device (N Engl J Med. 2018 April 12; 378[15]:1386-95).

mzoler@mdedge.com

The HeartMate 3 left ventricular assist device received a class 1 recall from the Food and Drug Administration on May 17, an action the agency publicly announced on May 22.

The FDA’s step formalized a “corrective action” that the HeartMate 3’s manufacturer, Abbott, first issued in early April and then announced in early May, which said the device used to treat patients with severe advanced heart failure was subject to “outflow graft twist occlusions” that trigger a persistent low-flow alarm and “can result in serious adverse events such as hemodynamic compromise, thrombus, and death,” according to the FDA’s May 17 statement.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The first letter attributed development of these twists in the tube that directs blood out from the device to accumulated mechanical forces from heartbeats, respiration, and activity, and also provided some management guidance that Abbott then expanded in its second letter.

The FDA cited some of the key steps Abbott recommended clinicians take with patients who receive a HeartMate 3. This included regular surveillance with transthoracic echocardiography, although echo is not considered definitive for identifying a graft twist obstruction and hence other investigations may also be needed. If the low-flow alarm sounds, a CT scan is “urgently” needed – as long as it’s not contraindicated – to identify a possible outflow twist. Abbott noted that surgical intervention may be needed to correct a twist.

Researchers recently reported 2-year follow-up data from 257 patients in MOMENTUM 3, the randomized pivotal trial for the HeartMate 3 that compared this fully magnetically levitated centrifugal-flow pump to the prior-generation, axial-flow pump. The composite endpoint of freedom from death, stroke, or need for repeat surgery after 2 years was 80% in the HeartMate 3 recipients and 60% among patients in the control arm who received the older-model device (N Engl J Med. 2018 April 12; 378[15]:1386-95).

mzoler@mdedge.com