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Study shows similar safety with DOACs and warfarin
New research suggests patients with venous thromboembolism (VTE) have similar safety outcomes whether they receive direct oral anticoagulants (DOACs) or warfarin.
The population-based study showed there was no significant difference in the risk of major bleeding and all-cause mortality at 90 days whether patients received warfarin or DOACs (apixaban, dabigatran, and rivaroxaban).
Brenda R. Hemmelgarn, MD, PhD, of the University of Calgary in Alberta, Canada, and her colleagues reported results from this study in The BMJ.
The researchers noted that recent clinical trials have shown similar effectiveness and a reduced or similar risk of major bleeding complications for DOACs compared with warfarin. However, clinical trials involve a highly selected group of patients, so the rate of safety events reported in trials may not reflect those seen in everyday clinical practice.
With this in mind, Dr Hemmelgarn and her colleagues conducted a population-based study to determine the safety of DOAC and warfarin use in adults diagnosed with VTE between January 1, 2009, and March 31, 2016.
Using healthcare data from 6 jurisdictions in Canada and the US, the researchers identified 59,525 adults with a new diagnosis of VTE and a prescription for a DOAC (n=12,489) or warfarin (n=47,036) within 30 days of diagnosis.
Participants were followed for an average of 85.2 days. Of the 59,525 participants, 1967 (3.3%) had a major bleed, and 1029 (1.7%) died during the follow-up period.
Bleeding rates at 30 days ranged between 0.2% and 2.9% for DOACs and 0.2% and 2.9% for warfarin.
Bleeding rates at 60 days ranged between 0.4% and 4.3% for DOACs and 0.4% and 4.3% for warfarin.
The hazard ratio for major bleeding at 90 days was 0.92 (favoring DOACs). The hazard ratio for all-cause mortality at 90 days was 0.99.
The researchers said there was no evidence of heterogeneity across treatment centers, between patients with and without chronic kidney disease, across age groups, or between male and female patients.
The team noted that this is an observational study, so no firm conclusions can be drawn about cause and effect. And they could not rule out the possibility that their results may be due to confounding factors. 
New research suggests patients with venous thromboembolism (VTE) have similar safety outcomes whether they receive direct oral anticoagulants (DOACs) or warfarin.
The population-based study showed there was no significant difference in the risk of major bleeding and all-cause mortality at 90 days whether patients received warfarin or DOACs (apixaban, dabigatran, and rivaroxaban).
Brenda R. Hemmelgarn, MD, PhD, of the University of Calgary in Alberta, Canada, and her colleagues reported results from this study in The BMJ.
The researchers noted that recent clinical trials have shown similar effectiveness and a reduced or similar risk of major bleeding complications for DOACs compared with warfarin. However, clinical trials involve a highly selected group of patients, so the rate of safety events reported in trials may not reflect those seen in everyday clinical practice.
With this in mind, Dr Hemmelgarn and her colleagues conducted a population-based study to determine the safety of DOAC and warfarin use in adults diagnosed with VTE between January 1, 2009, and March 31, 2016.
Using healthcare data from 6 jurisdictions in Canada and the US, the researchers identified 59,525 adults with a new diagnosis of VTE and a prescription for a DOAC (n=12,489) or warfarin (n=47,036) within 30 days of diagnosis.
Participants were followed for an average of 85.2 days. Of the 59,525 participants, 1967 (3.3%) had a major bleed, and 1029 (1.7%) died during the follow-up period.
Bleeding rates at 30 days ranged between 0.2% and 2.9% for DOACs and 0.2% and 2.9% for warfarin.
Bleeding rates at 60 days ranged between 0.4% and 4.3% for DOACs and 0.4% and 4.3% for warfarin.
The hazard ratio for major bleeding at 90 days was 0.92 (favoring DOACs). The hazard ratio for all-cause mortality at 90 days was 0.99.
The researchers said there was no evidence of heterogeneity across treatment centers, between patients with and without chronic kidney disease, across age groups, or between male and female patients.
The team noted that this is an observational study, so no firm conclusions can be drawn about cause and effect. And they could not rule out the possibility that their results may be due to confounding factors.
New research suggests patients with venous thromboembolism (VTE) have similar safety outcomes whether they receive direct oral anticoagulants (DOACs) or warfarin.
The population-based study showed there was no significant difference in the risk of major bleeding and all-cause mortality at 90 days whether patients received warfarin or DOACs (apixaban, dabigatran, and rivaroxaban).
Brenda R. Hemmelgarn, MD, PhD, of the University of Calgary in Alberta, Canada, and her colleagues reported results from this study in The BMJ.
The researchers noted that recent clinical trials have shown similar effectiveness and a reduced or similar risk of major bleeding complications for DOACs compared with warfarin. However, clinical trials involve a highly selected group of patients, so the rate of safety events reported in trials may not reflect those seen in everyday clinical practice.
With this in mind, Dr Hemmelgarn and her colleagues conducted a population-based study to determine the safety of DOAC and warfarin use in adults diagnosed with VTE between January 1, 2009, and March 31, 2016.
Using healthcare data from 6 jurisdictions in Canada and the US, the researchers identified 59,525 adults with a new diagnosis of VTE and a prescription for a DOAC (n=12,489) or warfarin (n=47,036) within 30 days of diagnosis.
Participants were followed for an average of 85.2 days. Of the 59,525 participants, 1967 (3.3%) had a major bleed, and 1029 (1.7%) died during the follow-up period.
Bleeding rates at 30 days ranged between 0.2% and 2.9% for DOACs and 0.2% and 2.9% for warfarin.
Bleeding rates at 60 days ranged between 0.4% and 4.3% for DOACs and 0.4% and 4.3% for warfarin.
The hazard ratio for major bleeding at 90 days was 0.92 (favoring DOACs). The hazard ratio for all-cause mortality at 90 days was 0.99.
The researchers said there was no evidence of heterogeneity across treatment centers, between patients with and without chronic kidney disease, across age groups, or between male and female patients.
The team noted that this is an observational study, so no firm conclusions can be drawn about cause and effect. And they could not rule out the possibility that their results may be due to confounding factors.
Women may ask fewer questions at scientific conferences
Women may ask fewer questions than men at scientific conferences, according to research published in PLOS ONE.
Researchers studied question-asking behavior at a large international conference and found that men asked 80% more questions than women.
“Previous research has shown that men are more likely to be invited to speak at conferences, which is likely to lead to them having a higher social reputation than their female peers,” said study author Amy Hinsley, PhD, of the University of Oxford in the UK.
“If women feel that they are low-status and have suffered discrimination and bias throughout their career, then they may be less likely to participate in public discussions, which will, in turn, affect their scientific reputation. This negative feedback loop can affect women and men, but the evidence in this study suggests that women are affected more.”
For this study, Dr Hinsley and her colleagues looked at question-asking behavior at the 2015 International Congress for Conservation Biology. The conference had a clear code of conduct for its 2000 attendees, which promoted equality and prohibited discrimination.
The authors observed 31 sessions across the 4-day conference, counting how many questions were asked and whether men or women were asking them.
Accounting for the number of men and women in the audience, men asked 1.8 questions for each question asked by a woman.
The same pattern was observed in younger researchers (1.8 to 1), suggesting it is not simply due to senior researchers, a large proportion of whom are men, asking all the questions.
Dr Hinsley and her colleagues feel this study should be used as an opportunity to raise awareness of the disparity in question-asking behavior between men and women and inspire discussion about why it is happening.
“We want our research to inspire conference organizers to encourage participation among all attendees,” said Alison Johnston, PhD, of Cambridge University in the UK.
“For example, questions over Twitter or other creative solutions could be tested. Session chairs could also be encouraged to pick participants that represent the gender in the audience. However, these patterns of behavior we observed are only a symptom of the bigger issue. Addressing this alone will not solve the problem [of gender inequality].”
“We should continue to research and investigate the underlying causes so we can implement actions that change the bigger picture for women in science. If we are to level the playing field for women in STEM, the complex issue of gender inequality has to stay on the agenda.”
Women may ask fewer questions than men at scientific conferences, according to research published in PLOS ONE.
Researchers studied question-asking behavior at a large international conference and found that men asked 80% more questions than women.
“Previous research has shown that men are more likely to be invited to speak at conferences, which is likely to lead to them having a higher social reputation than their female peers,” said study author Amy Hinsley, PhD, of the University of Oxford in the UK.
“If women feel that they are low-status and have suffered discrimination and bias throughout their career, then they may be less likely to participate in public discussions, which will, in turn, affect their scientific reputation. This negative feedback loop can affect women and men, but the evidence in this study suggests that women are affected more.”
For this study, Dr Hinsley and her colleagues looked at question-asking behavior at the 2015 International Congress for Conservation Biology. The conference had a clear code of conduct for its 2000 attendees, which promoted equality and prohibited discrimination.
The authors observed 31 sessions across the 4-day conference, counting how many questions were asked and whether men or women were asking them.
Accounting for the number of men and women in the audience, men asked 1.8 questions for each question asked by a woman.
The same pattern was observed in younger researchers (1.8 to 1), suggesting it is not simply due to senior researchers, a large proportion of whom are men, asking all the questions.
Dr Hinsley and her colleagues feel this study should be used as an opportunity to raise awareness of the disparity in question-asking behavior between men and women and inspire discussion about why it is happening.
“We want our research to inspire conference organizers to encourage participation among all attendees,” said Alison Johnston, PhD, of Cambridge University in the UK.
“For example, questions over Twitter or other creative solutions could be tested. Session chairs could also be encouraged to pick participants that represent the gender in the audience. However, these patterns of behavior we observed are only a symptom of the bigger issue. Addressing this alone will not solve the problem [of gender inequality].”
“We should continue to research and investigate the underlying causes so we can implement actions that change the bigger picture for women in science. If we are to level the playing field for women in STEM, the complex issue of gender inequality has to stay on the agenda.”
Women may ask fewer questions than men at scientific conferences, according to research published in PLOS ONE.
Researchers studied question-asking behavior at a large international conference and found that men asked 80% more questions than women.
“Previous research has shown that men are more likely to be invited to speak at conferences, which is likely to lead to them having a higher social reputation than their female peers,” said study author Amy Hinsley, PhD, of the University of Oxford in the UK.
“If women feel that they are low-status and have suffered discrimination and bias throughout their career, then they may be less likely to participate in public discussions, which will, in turn, affect their scientific reputation. This negative feedback loop can affect women and men, but the evidence in this study suggests that women are affected more.”
For this study, Dr Hinsley and her colleagues looked at question-asking behavior at the 2015 International Congress for Conservation Biology. The conference had a clear code of conduct for its 2000 attendees, which promoted equality and prohibited discrimination.
The authors observed 31 sessions across the 4-day conference, counting how many questions were asked and whether men or women were asking them.
Accounting for the number of men and women in the audience, men asked 1.8 questions for each question asked by a woman.
The same pattern was observed in younger researchers (1.8 to 1), suggesting it is not simply due to senior researchers, a large proportion of whom are men, asking all the questions.
Dr Hinsley and her colleagues feel this study should be used as an opportunity to raise awareness of the disparity in question-asking behavior between men and women and inspire discussion about why it is happening.
“We want our research to inspire conference organizers to encourage participation among all attendees,” said Alison Johnston, PhD, of Cambridge University in the UK.
“For example, questions over Twitter or other creative solutions could be tested. Session chairs could also be encouraged to pick participants that represent the gender in the audience. However, these patterns of behavior we observed are only a symptom of the bigger issue. Addressing this alone will not solve the problem [of gender inequality].”
“We should continue to research and investigate the underlying causes so we can implement actions that change the bigger picture for women in science. If we are to level the playing field for women in STEM, the complex issue of gender inequality has to stay on the agenda.”
High ‘nocebo’ effect observed when patients knowingly switch to a biosimilar
Evidence suggests that patients who switch from an originator biologic to open-label treatment with its biosimilar have an increase in subjective but not objective assessments and also discontinue the drug at a high rate, possibly reflecting a “nocebo” response to switching.
If patients’ own negative expectations induced “negative symptoms (hyperalgesia or adverse events) during treatment, the so-called nocebo response,” and was the main contributing factor to the high discontinuation rate, then it will be very important for clinicians to improve communication with patients and their expectations in order to raise acceptance and persistence rates, the investigators said.
Of the 47 patients who discontinued CT-P13, 26 did so because of a perceived lack of effect, 11 because of adverse events, and 10 because of a combination of both of these factors.
Univariate Cox regression analyses showed that shorter infliximab infusion interval, higher 28-joint Disease Activity Scores (DAS28, based on either C-reactive protein [CRP] or erythrocyte sedimentation rate), higher swollen joint count, and patients’ global disease activity score at baseline were associated with CT-P13 discontinuation.
However, patients’ and clinicians’ awareness of the switch could have influenced these factors, the investigators said. For instance, they found that patients who discontinued CT-P13 reported a significant increase in “subjective” assessments such as tender joint count and patient’s global disease activity but not “objective” measures such as swollen joint count or CRP.
While the mean Bath Ankylosing Spondylitis Disease Activity Index score increased from 3.8 to 4.3, the mean DAS28-CRP in rheumatoid arthritis and psoriatic arthritis patients remained stable at 2.2 from baseline to month 6; CRP and anti-infliximab antibody levels also did not change.
“If immunogenicity would have caused CT-P13 discontinuation, we would have expected to find more patients with objectively active disease and/or allergic reactions,” the study authors wrote.
Three of the authors reported receiving speaking and consultancy fees from several pharmaceutical companies. The study was not supported by an outside grant.
Evidence suggests that patients who switch from an originator biologic to open-label treatment with its biosimilar have an increase in subjective but not objective assessments and also discontinue the drug at a high rate, possibly reflecting a “nocebo” response to switching.
If patients’ own negative expectations induced “negative symptoms (hyperalgesia or adverse events) during treatment, the so-called nocebo response,” and was the main contributing factor to the high discontinuation rate, then it will be very important for clinicians to improve communication with patients and their expectations in order to raise acceptance and persistence rates, the investigators said.
Of the 47 patients who discontinued CT-P13, 26 did so because of a perceived lack of effect, 11 because of adverse events, and 10 because of a combination of both of these factors.
Univariate Cox regression analyses showed that shorter infliximab infusion interval, higher 28-joint Disease Activity Scores (DAS28, based on either C-reactive protein [CRP] or erythrocyte sedimentation rate), higher swollen joint count, and patients’ global disease activity score at baseline were associated with CT-P13 discontinuation.
However, patients’ and clinicians’ awareness of the switch could have influenced these factors, the investigators said. For instance, they found that patients who discontinued CT-P13 reported a significant increase in “subjective” assessments such as tender joint count and patient’s global disease activity but not “objective” measures such as swollen joint count or CRP.
While the mean Bath Ankylosing Spondylitis Disease Activity Index score increased from 3.8 to 4.3, the mean DAS28-CRP in rheumatoid arthritis and psoriatic arthritis patients remained stable at 2.2 from baseline to month 6; CRP and anti-infliximab antibody levels also did not change.
“If immunogenicity would have caused CT-P13 discontinuation, we would have expected to find more patients with objectively active disease and/or allergic reactions,” the study authors wrote.
Three of the authors reported receiving speaking and consultancy fees from several pharmaceutical companies. The study was not supported by an outside grant.
Evidence suggests that patients who switch from an originator biologic to open-label treatment with its biosimilar have an increase in subjective but not objective assessments and also discontinue the drug at a high rate, possibly reflecting a “nocebo” response to switching.
If patients’ own negative expectations induced “negative symptoms (hyperalgesia or adverse events) during treatment, the so-called nocebo response,” and was the main contributing factor to the high discontinuation rate, then it will be very important for clinicians to improve communication with patients and their expectations in order to raise acceptance and persistence rates, the investigators said.
Of the 47 patients who discontinued CT-P13, 26 did so because of a perceived lack of effect, 11 because of adverse events, and 10 because of a combination of both of these factors.
Univariate Cox regression analyses showed that shorter infliximab infusion interval, higher 28-joint Disease Activity Scores (DAS28, based on either C-reactive protein [CRP] or erythrocyte sedimentation rate), higher swollen joint count, and patients’ global disease activity score at baseline were associated with CT-P13 discontinuation.
However, patients’ and clinicians’ awareness of the switch could have influenced these factors, the investigators said. For instance, they found that patients who discontinued CT-P13 reported a significant increase in “subjective” assessments such as tender joint count and patient’s global disease activity but not “objective” measures such as swollen joint count or CRP.
While the mean Bath Ankylosing Spondylitis Disease Activity Index score increased from 3.8 to 4.3, the mean DAS28-CRP in rheumatoid arthritis and psoriatic arthritis patients remained stable at 2.2 from baseline to month 6; CRP and anti-infliximab antibody levels also did not change.
“If immunogenicity would have caused CT-P13 discontinuation, we would have expected to find more patients with objectively active disease and/or allergic reactions,” the study authors wrote.
Three of the authors reported receiving speaking and consultancy fees from several pharmaceutical companies. The study was not supported by an outside grant.
FROM ARTHRITIS & RHEUMATOLOGY
Key clinical point:
Major finding: Nearly a quarter of 192 patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, who knowingly switched from originator infliximab to its biosimilar CT-P13 discontinued the biosimilar during 6 months of follow-up.
Data source: A multicenter, prospective cohort study of 192 infliximab-treated patients who transitioned to the infliximab biosimilar CT-P13.
Disclosures: Three of the authors reported receiving speaking and consultancy fees from several pharmaceutical companies. The study was not supported by an outside grant.
CardioMEMS shows real-world success as use expands
DALLAS – Management of outpatients with advanced heart failure using an implanted pulmonary artery pressure monitor continues to show real-world efficacy and safety at least as impressive as in the pivotal trial for the device.
Data from the first waves of patients to receive the CardioMEMS implanted pulmonary artery pressure (PAP) monitor since it got Food and Drug Administration marketing approval in May 2014 also showed steady uptake of this fluid volume management strategy for patients with advanced heart failure, despite Medicare reimbursement issues in some U.S. regions, J. Thomas Heywood, MD, said at the at the annual scientific meeting of the Heart Failure Society of America. He estimated that more than 6,000 U.S. heart failure patients have now had a CardioMEMS PAP monitor implanted.
“The clinicians using CardioMEMS now have a lot more experience” than they had during the trial, he said in an interview. “They have more experience using the device, they know what treatments to use to lower PAP more effectively, and they are now convinced that patients will benefit from reducing diastolic PAP.”
Dr. Heywood estimated that tens of thousands more U.S. heart failure patients with New York Heart Association class III disease and a recent history of at least one heart failure hospitalization are eligible to receive an implanted PAP monitor, dwarfing the more than 6,000 patients who received a device so far.
The postapproval study
The newest efficacy data come from the first 300 patients enrolled in the CardioMEMS HF System Post Approval Study, a registry of patients receiving an implanted PAP monitor funded by the device’s manufacturer and scheduled to include a total of 1,200 patients. Dr. Heywood said full enrollment was on track for completion by the end of October 2017.
The first 300 patients enrolled in the postapproval study were older than the CHAMPION cohort; they averaged about 69 years of age, compared with about 62 years in CHAMPION, were more often women (38% vs. 28% in CHAMPION), and were more likely to have heart failure with preserved ejection fraction (41% vs. about 22%).
A similar pattern existed for the 6-month cumulative tally of PAP area under the curve, which showed an average rise of 42 mm Hg/day in the CHAMPION control patients, an average drop of 160 mm Hg/day in the CHAMPION patients managed using their CardioMEMS data, and a drop of 281 mm Hg/day in the 300 postapproval study patients.
“We’re now using the implanted sensor in a broader population of patients, and one wonders whether the effect will be diluted. What we see is at least as good as in the CHAMPION trial. This is just an early snapshot, but it is exciting that we see no erosion of the benefit. It’s a great indication that the correct patients are receiving it,” Dr. Raval said while presenting a poster at the meeting.
Further scrutiny of the same 300 patients showed another feature of the impact of PAP monitoring on patient outcomes: The first 90 days with the PAP monitor in place led to a greater number of tweaks in patient treatment and a steady fall in PAP. During days 91-180, PAP tended to level off, the number of medication adjustments dropped, and heart failure hospitalizations fell even more than in the first 90 days, Joanna M. Joly, MD, reported in a separate poster at the meeting.
The data showed “effective reduction” of PAP during the second half of the study despite fewer medication adjustments. How was that possible? Patients who transmit data on their PAPs undergo “modeling of their behavior” based on the feedback they receive from the device, Dr. Joly suggested. Regular measurement of their PAP and seeing how the number relates to their clinical status helps patients “understand the impact of their nonadherence to diet and their medications.” Another factor could be the growing familiarity clinicians develop over time with PAP fluctuations that individual patients display repeatedly that are usually self-correcting. Also, patients may undergo “hemodynamic remodeling” that results in improved self-correction of minor shifts in fluid volume and vascular tone, she said.
This pattern of a reduced need for interventions after the first 90 days with a PAP implant suggests that many patients managed this way may be able to transition to care largely delivered by local providers, or even play a greater role in their own self-care once their PAP and clinical state stabilizes, Dr. Joly said.
The findings imply that by the end of the first 90 days, “patients accept the device and manage themselves better. It becomes basically a behavioral device” that helps patients better optimize their diet and behavior, Dr. Raval observed.
Safety holds steady
Continued real-world use of PAP monitoring has also resulted in new safety insights. During the first 3 years when the CardioMEMS device was on the U.S. market, May 2014–May 2017, the FDA’s adverse event reporting system for devices, the Manufacturer and User Facility Device Experience (MAUDE) received reports on 177 unique adverse events in 155 patients implanted with a PAP monitor, Muthiah Vaduganathan, MD, reported at the meeting. During the same 3-year period, he estimated that at least 5,500 U.S. patients had received a CardioMEMS device, based on data Dr. Vaduganathan obtained from the manufacturer, Abbott. This works out to an adverse event rate of about 2.8%, virtually identical to the rate reported from CHAMPION, noted Dr. Vaduganathan, a cardiologist also at Brigham and Women’s.
Analysis of both the 22 deaths as well as the episodes of pulmonary artery injury or hemoptysis showed that the preponderance occurred relatively early after introduction for U.S. use, suggesting that “a learning curve may exist for the most serious complications,” he said. “Improved safety and device durability may result from careful patient selection, increased operator training, and refined technologies.”
Dr. Vaduganathan cautioned that the MAUDE database is limited by its bias toward serious adverse events, selective reporting, and lack of adjudication for the reported events. Concurrently with his report at the meeting, a written version appeared online (JAMA Cardiol. 2017 Sep 18. doi:10.1001/jamacardio.2017.3791).
“The adverse event rate was reassuringly low, well below the accepted threshold for device safety. It bodes favorably for the device,” he said in an interview.
“But with a passive surveillance system like MAUDE, adverse events are likely underreported; we see in MAUDE the most severe adverse events. There is certainly a larger spectrum of more minor events that we are not seeing, but I think these numbers accurately reflect serious events.” A full registry of every U.S. patient who receives the device, similar to what’s in place for U.S. patients who undergo transcatheter aortic valve replacement, would provide a more complete picture of the risks, Dr. Vaduganathan suggested.
He also voiced some surprise about the frequency of pulmonary artery injury, which was not as apparent in the 550 total patients enrolled in CHAMPION. Clinicians who place the PAP monitor are required to first take a training program, but the manufacturer has no mandated minimum number of placements an operator must assist on before launching a new CardioMEMS practice, Dr. Vaduganathan said. Many of the pulmonary artery injuries reported to MAUDE resulted from wire perforations that resulted from loss of wire control, he noted.
Clarifying the optimal CardioMEMS recipients
PAP monitoring for patients with advanced heart failure “is a major advance for certain patients who have historically been very challenging to manage,” especially patients with heart failure with preserved ejection fraction, which has few other treatment options. But “it’s often difficult to know when to pull the trigger” and proceed with placing a PAP monitor in an eligible patient, he said. “Greater experience will help us better understand that,” Dr. Vaduganathan predicted.
Dr. Heywood said that, in addition to the standard criteria of NYHA class III symptoms and a recent history of a heart failure hospitalization, the other clinical feature he looks for in a patient who is a possible CardioMEMS recipient is a persistently elevated systolic PAP as measured using echocardiography.
“These are patients with evidence of an ongoing hemodynamic problem despite treatment, and I need more data to do a better job of getting their PAP down.” Although the PAP that patients self-measure once they have the device in place is their diastolic PAP, measuring systolic PAP by echo is usually a good surrogate for finding patients who also have a persistently elevated diastolic PAP, he explained.
Another important selection criterion is to look for the patients who are dying from heart failure rather than with heart failure, Dr. Heywood added.
“If heart failure is the major thing wrong, then we can improve their quality of life” by guiding fluid management with regular PAP measurement, especially patients with preserved left ventricular ejection fraction who have few other treatment options right now, he said.
The CardioMEMS HF System Post Approval Study is sponsored by Abbott, which markets CardioMEMS. Dr Heywood has been a consultant to and/or has received research funding from Abbott as well as Impedimed, Medtronic, Novartis, and Otsuka. Dr. Raval has been a consultant to Abbott. Dr. Joly and Dr. Vaduganathan had no disclosures.
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On Twitter @mitchelzoler
DALLAS – Management of outpatients with advanced heart failure using an implanted pulmonary artery pressure monitor continues to show real-world efficacy and safety at least as impressive as in the pivotal trial for the device.
Data from the first waves of patients to receive the CardioMEMS implanted pulmonary artery pressure (PAP) monitor since it got Food and Drug Administration marketing approval in May 2014 also showed steady uptake of this fluid volume management strategy for patients with advanced heart failure, despite Medicare reimbursement issues in some U.S. regions, J. Thomas Heywood, MD, said at the at the annual scientific meeting of the Heart Failure Society of America. He estimated that more than 6,000 U.S. heart failure patients have now had a CardioMEMS PAP monitor implanted.
“The clinicians using CardioMEMS now have a lot more experience” than they had during the trial, he said in an interview. “They have more experience using the device, they know what treatments to use to lower PAP more effectively, and they are now convinced that patients will benefit from reducing diastolic PAP.”
Dr. Heywood estimated that tens of thousands more U.S. heart failure patients with New York Heart Association class III disease and a recent history of at least one heart failure hospitalization are eligible to receive an implanted PAP monitor, dwarfing the more than 6,000 patients who received a device so far.
The postapproval study
The newest efficacy data come from the first 300 patients enrolled in the CardioMEMS HF System Post Approval Study, a registry of patients receiving an implanted PAP monitor funded by the device’s manufacturer and scheduled to include a total of 1,200 patients. Dr. Heywood said full enrollment was on track for completion by the end of October 2017.
The first 300 patients enrolled in the postapproval study were older than the CHAMPION cohort; they averaged about 69 years of age, compared with about 62 years in CHAMPION, were more often women (38% vs. 28% in CHAMPION), and were more likely to have heart failure with preserved ejection fraction (41% vs. about 22%).
A similar pattern existed for the 6-month cumulative tally of PAP area under the curve, which showed an average rise of 42 mm Hg/day in the CHAMPION control patients, an average drop of 160 mm Hg/day in the CHAMPION patients managed using their CardioMEMS data, and a drop of 281 mm Hg/day in the 300 postapproval study patients.
“We’re now using the implanted sensor in a broader population of patients, and one wonders whether the effect will be diluted. What we see is at least as good as in the CHAMPION trial. This is just an early snapshot, but it is exciting that we see no erosion of the benefit. It’s a great indication that the correct patients are receiving it,” Dr. Raval said while presenting a poster at the meeting.
Further scrutiny of the same 300 patients showed another feature of the impact of PAP monitoring on patient outcomes: The first 90 days with the PAP monitor in place led to a greater number of tweaks in patient treatment and a steady fall in PAP. During days 91-180, PAP tended to level off, the number of medication adjustments dropped, and heart failure hospitalizations fell even more than in the first 90 days, Joanna M. Joly, MD, reported in a separate poster at the meeting.
The data showed “effective reduction” of PAP during the second half of the study despite fewer medication adjustments. How was that possible? Patients who transmit data on their PAPs undergo “modeling of their behavior” based on the feedback they receive from the device, Dr. Joly suggested. Regular measurement of their PAP and seeing how the number relates to their clinical status helps patients “understand the impact of their nonadherence to diet and their medications.” Another factor could be the growing familiarity clinicians develop over time with PAP fluctuations that individual patients display repeatedly that are usually self-correcting. Also, patients may undergo “hemodynamic remodeling” that results in improved self-correction of minor shifts in fluid volume and vascular tone, she said.
This pattern of a reduced need for interventions after the first 90 days with a PAP implant suggests that many patients managed this way may be able to transition to care largely delivered by local providers, or even play a greater role in their own self-care once their PAP and clinical state stabilizes, Dr. Joly said.
The findings imply that by the end of the first 90 days, “patients accept the device and manage themselves better. It becomes basically a behavioral device” that helps patients better optimize their diet and behavior, Dr. Raval observed.
Safety holds steady
Continued real-world use of PAP monitoring has also resulted in new safety insights. During the first 3 years when the CardioMEMS device was on the U.S. market, May 2014–May 2017, the FDA’s adverse event reporting system for devices, the Manufacturer and User Facility Device Experience (MAUDE) received reports on 177 unique adverse events in 155 patients implanted with a PAP monitor, Muthiah Vaduganathan, MD, reported at the meeting. During the same 3-year period, he estimated that at least 5,500 U.S. patients had received a CardioMEMS device, based on data Dr. Vaduganathan obtained from the manufacturer, Abbott. This works out to an adverse event rate of about 2.8%, virtually identical to the rate reported from CHAMPION, noted Dr. Vaduganathan, a cardiologist also at Brigham and Women’s.
Analysis of both the 22 deaths as well as the episodes of pulmonary artery injury or hemoptysis showed that the preponderance occurred relatively early after introduction for U.S. use, suggesting that “a learning curve may exist for the most serious complications,” he said. “Improved safety and device durability may result from careful patient selection, increased operator training, and refined technologies.”
Dr. Vaduganathan cautioned that the MAUDE database is limited by its bias toward serious adverse events, selective reporting, and lack of adjudication for the reported events. Concurrently with his report at the meeting, a written version appeared online (JAMA Cardiol. 2017 Sep 18. doi:10.1001/jamacardio.2017.3791).
“The adverse event rate was reassuringly low, well below the accepted threshold for device safety. It bodes favorably for the device,” he said in an interview.
“But with a passive surveillance system like MAUDE, adverse events are likely underreported; we see in MAUDE the most severe adverse events. There is certainly a larger spectrum of more minor events that we are not seeing, but I think these numbers accurately reflect serious events.” A full registry of every U.S. patient who receives the device, similar to what’s in place for U.S. patients who undergo transcatheter aortic valve replacement, would provide a more complete picture of the risks, Dr. Vaduganathan suggested.
He also voiced some surprise about the frequency of pulmonary artery injury, which was not as apparent in the 550 total patients enrolled in CHAMPION. Clinicians who place the PAP monitor are required to first take a training program, but the manufacturer has no mandated minimum number of placements an operator must assist on before launching a new CardioMEMS practice, Dr. Vaduganathan said. Many of the pulmonary artery injuries reported to MAUDE resulted from wire perforations that resulted from loss of wire control, he noted.
Clarifying the optimal CardioMEMS recipients
PAP monitoring for patients with advanced heart failure “is a major advance for certain patients who have historically been very challenging to manage,” especially patients with heart failure with preserved ejection fraction, which has few other treatment options. But “it’s often difficult to know when to pull the trigger” and proceed with placing a PAP monitor in an eligible patient, he said. “Greater experience will help us better understand that,” Dr. Vaduganathan predicted.
Dr. Heywood said that, in addition to the standard criteria of NYHA class III symptoms and a recent history of a heart failure hospitalization, the other clinical feature he looks for in a patient who is a possible CardioMEMS recipient is a persistently elevated systolic PAP as measured using echocardiography.
“These are patients with evidence of an ongoing hemodynamic problem despite treatment, and I need more data to do a better job of getting their PAP down.” Although the PAP that patients self-measure once they have the device in place is their diastolic PAP, measuring systolic PAP by echo is usually a good surrogate for finding patients who also have a persistently elevated diastolic PAP, he explained.
Another important selection criterion is to look for the patients who are dying from heart failure rather than with heart failure, Dr. Heywood added.
“If heart failure is the major thing wrong, then we can improve their quality of life” by guiding fluid management with regular PAP measurement, especially patients with preserved left ventricular ejection fraction who have few other treatment options right now, he said.
The CardioMEMS HF System Post Approval Study is sponsored by Abbott, which markets CardioMEMS. Dr Heywood has been a consultant to and/or has received research funding from Abbott as well as Impedimed, Medtronic, Novartis, and Otsuka. Dr. Raval has been a consultant to Abbott. Dr. Joly and Dr. Vaduganathan had no disclosures.
[email protected]
On Twitter @mitchelzoler
DALLAS – Management of outpatients with advanced heart failure using an implanted pulmonary artery pressure monitor continues to show real-world efficacy and safety at least as impressive as in the pivotal trial for the device.
Data from the first waves of patients to receive the CardioMEMS implanted pulmonary artery pressure (PAP) monitor since it got Food and Drug Administration marketing approval in May 2014 also showed steady uptake of this fluid volume management strategy for patients with advanced heart failure, despite Medicare reimbursement issues in some U.S. regions, J. Thomas Heywood, MD, said at the at the annual scientific meeting of the Heart Failure Society of America. He estimated that more than 6,000 U.S. heart failure patients have now had a CardioMEMS PAP monitor implanted.
“The clinicians using CardioMEMS now have a lot more experience” than they had during the trial, he said in an interview. “They have more experience using the device, they know what treatments to use to lower PAP more effectively, and they are now convinced that patients will benefit from reducing diastolic PAP.”
Dr. Heywood estimated that tens of thousands more U.S. heart failure patients with New York Heart Association class III disease and a recent history of at least one heart failure hospitalization are eligible to receive an implanted PAP monitor, dwarfing the more than 6,000 patients who received a device so far.
The postapproval study
The newest efficacy data come from the first 300 patients enrolled in the CardioMEMS HF System Post Approval Study, a registry of patients receiving an implanted PAP monitor funded by the device’s manufacturer and scheduled to include a total of 1,200 patients. Dr. Heywood said full enrollment was on track for completion by the end of October 2017.
The first 300 patients enrolled in the postapproval study were older than the CHAMPION cohort; they averaged about 69 years of age, compared with about 62 years in CHAMPION, were more often women (38% vs. 28% in CHAMPION), and were more likely to have heart failure with preserved ejection fraction (41% vs. about 22%).
A similar pattern existed for the 6-month cumulative tally of PAP area under the curve, which showed an average rise of 42 mm Hg/day in the CHAMPION control patients, an average drop of 160 mm Hg/day in the CHAMPION patients managed using their CardioMEMS data, and a drop of 281 mm Hg/day in the 300 postapproval study patients.
“We’re now using the implanted sensor in a broader population of patients, and one wonders whether the effect will be diluted. What we see is at least as good as in the CHAMPION trial. This is just an early snapshot, but it is exciting that we see no erosion of the benefit. It’s a great indication that the correct patients are receiving it,” Dr. Raval said while presenting a poster at the meeting.
Further scrutiny of the same 300 patients showed another feature of the impact of PAP monitoring on patient outcomes: The first 90 days with the PAP monitor in place led to a greater number of tweaks in patient treatment and a steady fall in PAP. During days 91-180, PAP tended to level off, the number of medication adjustments dropped, and heart failure hospitalizations fell even more than in the first 90 days, Joanna M. Joly, MD, reported in a separate poster at the meeting.
The data showed “effective reduction” of PAP during the second half of the study despite fewer medication adjustments. How was that possible? Patients who transmit data on their PAPs undergo “modeling of their behavior” based on the feedback they receive from the device, Dr. Joly suggested. Regular measurement of their PAP and seeing how the number relates to their clinical status helps patients “understand the impact of their nonadherence to diet and their medications.” Another factor could be the growing familiarity clinicians develop over time with PAP fluctuations that individual patients display repeatedly that are usually self-correcting. Also, patients may undergo “hemodynamic remodeling” that results in improved self-correction of minor shifts in fluid volume and vascular tone, she said.
This pattern of a reduced need for interventions after the first 90 days with a PAP implant suggests that many patients managed this way may be able to transition to care largely delivered by local providers, or even play a greater role in their own self-care once their PAP and clinical state stabilizes, Dr. Joly said.
The findings imply that by the end of the first 90 days, “patients accept the device and manage themselves better. It becomes basically a behavioral device” that helps patients better optimize their diet and behavior, Dr. Raval observed.
Safety holds steady
Continued real-world use of PAP monitoring has also resulted in new safety insights. During the first 3 years when the CardioMEMS device was on the U.S. market, May 2014–May 2017, the FDA’s adverse event reporting system for devices, the Manufacturer and User Facility Device Experience (MAUDE) received reports on 177 unique adverse events in 155 patients implanted with a PAP monitor, Muthiah Vaduganathan, MD, reported at the meeting. During the same 3-year period, he estimated that at least 5,500 U.S. patients had received a CardioMEMS device, based on data Dr. Vaduganathan obtained from the manufacturer, Abbott. This works out to an adverse event rate of about 2.8%, virtually identical to the rate reported from CHAMPION, noted Dr. Vaduganathan, a cardiologist also at Brigham and Women’s.
Analysis of both the 22 deaths as well as the episodes of pulmonary artery injury or hemoptysis showed that the preponderance occurred relatively early after introduction for U.S. use, suggesting that “a learning curve may exist for the most serious complications,” he said. “Improved safety and device durability may result from careful patient selection, increased operator training, and refined technologies.”
Dr. Vaduganathan cautioned that the MAUDE database is limited by its bias toward serious adverse events, selective reporting, and lack of adjudication for the reported events. Concurrently with his report at the meeting, a written version appeared online (JAMA Cardiol. 2017 Sep 18. doi:10.1001/jamacardio.2017.3791).
“The adverse event rate was reassuringly low, well below the accepted threshold for device safety. It bodes favorably for the device,” he said in an interview.
“But with a passive surveillance system like MAUDE, adverse events are likely underreported; we see in MAUDE the most severe adverse events. There is certainly a larger spectrum of more minor events that we are not seeing, but I think these numbers accurately reflect serious events.” A full registry of every U.S. patient who receives the device, similar to what’s in place for U.S. patients who undergo transcatheter aortic valve replacement, would provide a more complete picture of the risks, Dr. Vaduganathan suggested.
He also voiced some surprise about the frequency of pulmonary artery injury, which was not as apparent in the 550 total patients enrolled in CHAMPION. Clinicians who place the PAP monitor are required to first take a training program, but the manufacturer has no mandated minimum number of placements an operator must assist on before launching a new CardioMEMS practice, Dr. Vaduganathan said. Many of the pulmonary artery injuries reported to MAUDE resulted from wire perforations that resulted from loss of wire control, he noted.
Clarifying the optimal CardioMEMS recipients
PAP monitoring for patients with advanced heart failure “is a major advance for certain patients who have historically been very challenging to manage,” especially patients with heart failure with preserved ejection fraction, which has few other treatment options. But “it’s often difficult to know when to pull the trigger” and proceed with placing a PAP monitor in an eligible patient, he said. “Greater experience will help us better understand that,” Dr. Vaduganathan predicted.
Dr. Heywood said that, in addition to the standard criteria of NYHA class III symptoms and a recent history of a heart failure hospitalization, the other clinical feature he looks for in a patient who is a possible CardioMEMS recipient is a persistently elevated systolic PAP as measured using echocardiography.
“These are patients with evidence of an ongoing hemodynamic problem despite treatment, and I need more data to do a better job of getting their PAP down.” Although the PAP that patients self-measure once they have the device in place is their diastolic PAP, measuring systolic PAP by echo is usually a good surrogate for finding patients who also have a persistently elevated diastolic PAP, he explained.
Another important selection criterion is to look for the patients who are dying from heart failure rather than with heart failure, Dr. Heywood added.
“If heart failure is the major thing wrong, then we can improve their quality of life” by guiding fluid management with regular PAP measurement, especially patients with preserved left ventricular ejection fraction who have few other treatment options right now, he said.
The CardioMEMS HF System Post Approval Study is sponsored by Abbott, which markets CardioMEMS. Dr Heywood has been a consultant to and/or has received research funding from Abbott as well as Impedimed, Medtronic, Novartis, and Otsuka. Dr. Raval has been a consultant to Abbott. Dr. Joly and Dr. Vaduganathan had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
VIDEO: Mobile stroke units aren’t just expensive toys
SAN DIEGO – Mobile stroke units are specially equipped ambulance units designed to respond and deliver treatment to stroke patients as swiftly as possible. They are outfitted with a portable CT scanner, a mobile lab, and specialized personnel, including a telemedicine unit to assist with diagnosis. If a patient is experiencing an ischemic stroke, the unit can deliver thrombolytic therapy on the spot, circumventing travel to an emergency department.
But are they cost effective? There are 13 active units in the United States, and they’re not cheap. They cost about $3.5 million to build and operate over 5 years, according to James Grotta, MD, a neurologist with the Memorial Hermann Medical Group and director of stroke research at Memorial Hermann–Texas Medical Center, both in Houston.
In a video interview at the annual meeting of the American Neurological Association, Dr. Grotta described how his group is studying the impact of mobile stroke units on time to treatment and the long-term costs and cost savings associated with them in an ongoing clinical trial that is comparing outcomes in patients eligible for tissue plasminogen activator when treated by a mobile stroke unit versus standard prehospital triage and transport by emergency medical services. The study is comparing outcomes when the mobile stroke unit and emergency medical services are the primary responders on alternating weeks. Primary outcomes include cost-effectiveness, the change in Rankin scale score from baseline to 90 days, and the diagnostic agreement between a vascular neurologist in the mobile stroke unit and a telemedicine vascular neurologist consulted from the unit.
Mobile stroke units can even supplement existing health care in case of an emergency. Dr. Grotta also recounted how one unit assisted during the aftermath of Hurricane Harvey.
SAN DIEGO – Mobile stroke units are specially equipped ambulance units designed to respond and deliver treatment to stroke patients as swiftly as possible. They are outfitted with a portable CT scanner, a mobile lab, and specialized personnel, including a telemedicine unit to assist with diagnosis. If a patient is experiencing an ischemic stroke, the unit can deliver thrombolytic therapy on the spot, circumventing travel to an emergency department.
But are they cost effective? There are 13 active units in the United States, and they’re not cheap. They cost about $3.5 million to build and operate over 5 years, according to James Grotta, MD, a neurologist with the Memorial Hermann Medical Group and director of stroke research at Memorial Hermann–Texas Medical Center, both in Houston.
In a video interview at the annual meeting of the American Neurological Association, Dr. Grotta described how his group is studying the impact of mobile stroke units on time to treatment and the long-term costs and cost savings associated with them in an ongoing clinical trial that is comparing outcomes in patients eligible for tissue plasminogen activator when treated by a mobile stroke unit versus standard prehospital triage and transport by emergency medical services. The study is comparing outcomes when the mobile stroke unit and emergency medical services are the primary responders on alternating weeks. Primary outcomes include cost-effectiveness, the change in Rankin scale score from baseline to 90 days, and the diagnostic agreement between a vascular neurologist in the mobile stroke unit and a telemedicine vascular neurologist consulted from the unit.
Mobile stroke units can even supplement existing health care in case of an emergency. Dr. Grotta also recounted how one unit assisted during the aftermath of Hurricane Harvey.
SAN DIEGO – Mobile stroke units are specially equipped ambulance units designed to respond and deliver treatment to stroke patients as swiftly as possible. They are outfitted with a portable CT scanner, a mobile lab, and specialized personnel, including a telemedicine unit to assist with diagnosis. If a patient is experiencing an ischemic stroke, the unit can deliver thrombolytic therapy on the spot, circumventing travel to an emergency department.
But are they cost effective? There are 13 active units in the United States, and they’re not cheap. They cost about $3.5 million to build and operate over 5 years, according to James Grotta, MD, a neurologist with the Memorial Hermann Medical Group and director of stroke research at Memorial Hermann–Texas Medical Center, both in Houston.
In a video interview at the annual meeting of the American Neurological Association, Dr. Grotta described how his group is studying the impact of mobile stroke units on time to treatment and the long-term costs and cost savings associated with them in an ongoing clinical trial that is comparing outcomes in patients eligible for tissue plasminogen activator when treated by a mobile stroke unit versus standard prehospital triage and transport by emergency medical services. The study is comparing outcomes when the mobile stroke unit and emergency medical services are the primary responders on alternating weeks. Primary outcomes include cost-effectiveness, the change in Rankin scale score from baseline to 90 days, and the diagnostic agreement between a vascular neurologist in the mobile stroke unit and a telemedicine vascular neurologist consulted from the unit.
Mobile stroke units can even supplement existing health care in case of an emergency. Dr. Grotta also recounted how one unit assisted during the aftermath of Hurricane Harvey.
AT ANA 2017
SHM’s RADEO Program aids safer opioid prescribing
In January 2017, the U.S. Centers for Medicare & Medicaid Services honored SHM for its hospital patient safety and quality improvement efforts. A big reason for the plaudits was the society’s successful program and implementation toolkit called Reducing Adverse Drug Events related to Opioids (RADEO), now in its second phase.
Kevin Vuernick, senior project manager of SHM’s Center for Hospital Innovation and Improvement, says that the freely available RADEO guide explains how to develop and carry out quality improvement projects related to inpatient opioid prescribing. One of the first steps was devising interventions that hospitalists could implement to reduce opioid-related adverse events. An independent evaluator will help analyze the program’s data, best practices, and outcomes.
Keri Holmes-Maybank, MD, MSCR, FHM, an academic hospitalist at the Medical University of South Carolina, Charleston, said that the RADEO guide has a been a “phenomenal” resource. Dr. Holmes-Maybank, who led her medical center’s involvement in RADEO’s first round, says the guide helped her identify areas that her institution could work on. For one project, the medical university implemented the Pasero Opioid-Induced Sedation Scale to help prevent adverse opioid-related events, such as life-threatening respiratory depression. For a second project, the center combined existing discharge information into a more complete document that could be given to patients to educate them and their caregivers better.
St. Anthony Hospital in Oklahoma City first used RADEO to revisit how it was evaluating patients’ pain and then widened the scope to reassess how it was managing its opioid treatment and narcotic use. “We just kept swinging at the tree, trying to hit the low-hanging fruit and seeing what we could improve upon,” said Matthew Jared, MD, a hospitalist at St. Anthony and its program lead during its involvement in phase one of RADEO.
Dr. Jared is hoping to build on the momentum with a plan to develop better in-house protocols for monitoring pain, employing alternative treatments, and establishing clear lines of communication. “That’s our next step forward: really taking what we’ve learned and beginning to implement it into a holistic type of pain management within the hospital that each physician can tailor to the individual patient but still have the framework to support them,” he said. This ambitious plan is precisely the goal of RADEO, Mr. Vuernick said: providing the catalyst for change not just for hospital medicine but also for entire institutions.
In January 2017, the U.S. Centers for Medicare & Medicaid Services honored SHM for its hospital patient safety and quality improvement efforts. A big reason for the plaudits was the society’s successful program and implementation toolkit called Reducing Adverse Drug Events related to Opioids (RADEO), now in its second phase.
Kevin Vuernick, senior project manager of SHM’s Center for Hospital Innovation and Improvement, says that the freely available RADEO guide explains how to develop and carry out quality improvement projects related to inpatient opioid prescribing. One of the first steps was devising interventions that hospitalists could implement to reduce opioid-related adverse events. An independent evaluator will help analyze the program’s data, best practices, and outcomes.
Keri Holmes-Maybank, MD, MSCR, FHM, an academic hospitalist at the Medical University of South Carolina, Charleston, said that the RADEO guide has a been a “phenomenal” resource. Dr. Holmes-Maybank, who led her medical center’s involvement in RADEO’s first round, says the guide helped her identify areas that her institution could work on. For one project, the medical university implemented the Pasero Opioid-Induced Sedation Scale to help prevent adverse opioid-related events, such as life-threatening respiratory depression. For a second project, the center combined existing discharge information into a more complete document that could be given to patients to educate them and their caregivers better.
St. Anthony Hospital in Oklahoma City first used RADEO to revisit how it was evaluating patients’ pain and then widened the scope to reassess how it was managing its opioid treatment and narcotic use. “We just kept swinging at the tree, trying to hit the low-hanging fruit and seeing what we could improve upon,” said Matthew Jared, MD, a hospitalist at St. Anthony and its program lead during its involvement in phase one of RADEO.
Dr. Jared is hoping to build on the momentum with a plan to develop better in-house protocols for monitoring pain, employing alternative treatments, and establishing clear lines of communication. “That’s our next step forward: really taking what we’ve learned and beginning to implement it into a holistic type of pain management within the hospital that each physician can tailor to the individual patient but still have the framework to support them,” he said. This ambitious plan is precisely the goal of RADEO, Mr. Vuernick said: providing the catalyst for change not just for hospital medicine but also for entire institutions.
In January 2017, the U.S. Centers for Medicare & Medicaid Services honored SHM for its hospital patient safety and quality improvement efforts. A big reason for the plaudits was the society’s successful program and implementation toolkit called Reducing Adverse Drug Events related to Opioids (RADEO), now in its second phase.
Kevin Vuernick, senior project manager of SHM’s Center for Hospital Innovation and Improvement, says that the freely available RADEO guide explains how to develop and carry out quality improvement projects related to inpatient opioid prescribing. One of the first steps was devising interventions that hospitalists could implement to reduce opioid-related adverse events. An independent evaluator will help analyze the program’s data, best practices, and outcomes.
Keri Holmes-Maybank, MD, MSCR, FHM, an academic hospitalist at the Medical University of South Carolina, Charleston, said that the RADEO guide has a been a “phenomenal” resource. Dr. Holmes-Maybank, who led her medical center’s involvement in RADEO’s first round, says the guide helped her identify areas that her institution could work on. For one project, the medical university implemented the Pasero Opioid-Induced Sedation Scale to help prevent adverse opioid-related events, such as life-threatening respiratory depression. For a second project, the center combined existing discharge information into a more complete document that could be given to patients to educate them and their caregivers better.
St. Anthony Hospital in Oklahoma City first used RADEO to revisit how it was evaluating patients’ pain and then widened the scope to reassess how it was managing its opioid treatment and narcotic use. “We just kept swinging at the tree, trying to hit the low-hanging fruit and seeing what we could improve upon,” said Matthew Jared, MD, a hospitalist at St. Anthony and its program lead during its involvement in phase one of RADEO.
Dr. Jared is hoping to build on the momentum with a plan to develop better in-house protocols for monitoring pain, employing alternative treatments, and establishing clear lines of communication. “That’s our next step forward: really taking what we’ve learned and beginning to implement it into a holistic type of pain management within the hospital that each physician can tailor to the individual patient but still have the framework to support them,” he said. This ambitious plan is precisely the goal of RADEO, Mr. Vuernick said: providing the catalyst for change not just for hospital medicine but also for entire institutions.
Sorting out syncope signs and symptoms in kids remains essential
CHICAGO – Syncope often is misdiagnosed in pediatric patients complaining of chest pain, and a new guideline released in 2017 could guide clinicians toward a more accurate differential diagnosis and help them know when immediate referral to cardiology or the emergency department is warranted.
“There are recent guidelines published this year which are helpful,” said Dr. Barbara Deal, the Getz Professor of Cardiology at Northwestern University in Chicago. “,” which is defined as transient loss of consciousness.
“Once you establish it is a simple vasovagal [cause], you need to educate patients on conditions that would promote this and the need to be anticipatory,” Dr. Deal said at the annual meeting of the American Academy of Pediatrics. “Further testing with an echo[cardiogram] should be done if you suspect heart disease or a rhythm disorder.”
Chest pain and syncope are common complaints that can lead to significant anxiety for patients, parents, and pediatric providers. The greatest cause of this anxiety is the prospect of a fatal or near-fatal event. An abnormal cardiac examination, any associated palpitations, and a history of urinary incontinence or traumatic injury are reasons to worry, she said. “Any of these should prompt an urgent consult to cardiology or the emergency department.”
Cardiac causes of chest pain include reflex or vasovagal syncope or even a more serious cardiac cause, such as arrhythmic or structural issues, Dr. Deal said. Symptoms that appear with exertion or stress also are very worrisome. “You would know if they have a heart murmur or stenosis – it’s these other things that don’t present with a cardiac abnormality: hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy,” she said. “If they have symptoms on exertion, pay attention. This is not good.”
Syncope often is misdiagnosed, Dr. Deal said. Approximately 35%-48% of patients classified as having syncope do not have actual syncope;rather they experience dizziness rather than a loss of consciousness. In a study of 194 children, for example, the leading etiologies diagnosed after evaluation for syncope included simple fainting in 49%, a vasopressor/vasovagal response in 14%, and possible seizure in 14% (J Am Coll Cardiol. 1997;29[6]:1039-45). Seven percent were diagnosed with syncope not otherwise specified in this series. Some other causes included psychogenic or orthostatic ones, hyperventilation, dysmenorrhea, vertigo, dehydration, trauma, stress, exhaustion, or an infectious condition.*
“When should you be thinking life-threatening syncope?” Dr. Deal asked. Arrhythmic disorders that are heritable, such as an ion channelopathy, are an example. “They don’t always feel the racing heartbeat, but they feel something is not right; they feel a sense of impending doom. Some families report signs during exercise like swimming, seizures, gargling noises, or unusual symptoms on awakening.”
Dr. Deal noted that ages 3-24 years are “the problem territory for cardiac arrest.” In this age group, 43%-55% of cardiac arrests are associated with hypertrophic cardiomyopathy or arrhythmias; about one in three will have prior syncope. “These causes are not detectable on physical examination and often are not detectable with ECG only,” adding to the differential diagnosis challenges.*
Refer to a pediatric cardiologist
For this reason and others, referral to a pediatric cardiologist is indicated instead of a consult with an adult cardiologist, Dr. Deal said. “You know how your kids will start with ‘no offense.’ Like, ‘no offense, Mom, but your hair looks awful.’ With moderate offense intended, having an adult cardiologist read a pediatric ECG and clear them is not adequate. They will be looking for ischemia or A-fib [atrial fibrillation]; they’re not looking for long QT syndrome, arrhythmogenic cardiomyopathy, or abnormal T waves.”
Early detection of long QT syndrome is optimal, Dr. Deal said, because symptom onset often is between infancy and age 7 years. In addition, mortality is highest in the first 2 decades of life. “I think this could be why adult cardiologists are not as concerned as we are,” Dr. Deal said. “The bad ones die before they reach adulthood.”
Ruling out a cardiac cause
The 2017 joint guideline defined syncope as a transient loss of consciousness. “By definition, you pass out, you’re not aware of where you are, and you cannot hear,” Dr. Deal said. If a patient reports they could hear people talking, they may have lost postural tone, but they did not have syncope, she added.
“Sometimes, we see teenagers who are said to pass out and are unresponsive for 5 minutes, 10 minutes, or 20 minutes. I’m usually relieved to hear that because that gets cardiac off the hook,” Dr. Deal said. “There is nothing cardiac that makes you pass out for 20 minutes, unless people are resuscitating you.” She added, “I’m not suggesting it’s not a significant problem that you need to get to the bottom of.”
Noncardiac etiologies can be neurologic, metabolic, drug-induced, or psychogenic. “This is where the detective work comes in.”
Keep clinical suspicion high for psychogenic syncope, Dr. Deal said. Psychogenic episodes stem from significant psychological stress, often something so profoundly bothersome that they cannot cope, such as sexual abuse.
A helpful tip for diagnosing the less worrisome vasovagal syncope is asking whether a patient was sitting to standing or standing a long time before an episode, Dr. Deal said. “A common complaint is that the family went to airport, got up early, didn’t eat, and ended up standing for a long time. Kids will say they don’t feel well, they fall down, and all hell breaks loose.” Other causes of vasovagal syncope include stress, pain, or a situational trigger, for example, when a person faints during a blood draw or immunization.
The 2017 guideline also set forth the evidence behind various medications used to lower the risk of syncope. However, Dr. Deal said, “If syncope only happens every 3 years when you go to an airport, it’s probably not worth daily therapy to prevent that.”
‘The world’s most boring test’
For the most part, lifestyle measures should work to address vasovagal syncope. A tilt table test can be useful to aid the differential diagnosis, but it’s recommended only when the etiology is unclear, Dr. Deal said. On the plus side, the tilt table test allows clinicians to reproduce symptoms in a controlled environment. On the downside, she added, “It’s the world’s most boring test. It’s a challenge for the cardiologist to stay awake. It’s very boring, until all hell breaks loose.”
“I find this helpful in the setting of kids with seizures and for kids with this atypical syncope where you just cannot convince the family that these 20-minute episodes of loss of consciousness are not near-death episodes.”
Dr. Deal had no relevant financial disclosures.
*This article was updated on 10/25/2017.
CHICAGO – Syncope often is misdiagnosed in pediatric patients complaining of chest pain, and a new guideline released in 2017 could guide clinicians toward a more accurate differential diagnosis and help them know when immediate referral to cardiology or the emergency department is warranted.
“There are recent guidelines published this year which are helpful,” said Dr. Barbara Deal, the Getz Professor of Cardiology at Northwestern University in Chicago. “,” which is defined as transient loss of consciousness.
“Once you establish it is a simple vasovagal [cause], you need to educate patients on conditions that would promote this and the need to be anticipatory,” Dr. Deal said at the annual meeting of the American Academy of Pediatrics. “Further testing with an echo[cardiogram] should be done if you suspect heart disease or a rhythm disorder.”
Chest pain and syncope are common complaints that can lead to significant anxiety for patients, parents, and pediatric providers. The greatest cause of this anxiety is the prospect of a fatal or near-fatal event. An abnormal cardiac examination, any associated palpitations, and a history of urinary incontinence or traumatic injury are reasons to worry, she said. “Any of these should prompt an urgent consult to cardiology or the emergency department.”
Cardiac causes of chest pain include reflex or vasovagal syncope or even a more serious cardiac cause, such as arrhythmic or structural issues, Dr. Deal said. Symptoms that appear with exertion or stress also are very worrisome. “You would know if they have a heart murmur or stenosis – it’s these other things that don’t present with a cardiac abnormality: hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy,” she said. “If they have symptoms on exertion, pay attention. This is not good.”
Syncope often is misdiagnosed, Dr. Deal said. Approximately 35%-48% of patients classified as having syncope do not have actual syncope;rather they experience dizziness rather than a loss of consciousness. In a study of 194 children, for example, the leading etiologies diagnosed after evaluation for syncope included simple fainting in 49%, a vasopressor/vasovagal response in 14%, and possible seizure in 14% (J Am Coll Cardiol. 1997;29[6]:1039-45). Seven percent were diagnosed with syncope not otherwise specified in this series. Some other causes included psychogenic or orthostatic ones, hyperventilation, dysmenorrhea, vertigo, dehydration, trauma, stress, exhaustion, or an infectious condition.*
“When should you be thinking life-threatening syncope?” Dr. Deal asked. Arrhythmic disorders that are heritable, such as an ion channelopathy, are an example. “They don’t always feel the racing heartbeat, but they feel something is not right; they feel a sense of impending doom. Some families report signs during exercise like swimming, seizures, gargling noises, or unusual symptoms on awakening.”
Dr. Deal noted that ages 3-24 years are “the problem territory for cardiac arrest.” In this age group, 43%-55% of cardiac arrests are associated with hypertrophic cardiomyopathy or arrhythmias; about one in three will have prior syncope. “These causes are not detectable on physical examination and often are not detectable with ECG only,” adding to the differential diagnosis challenges.*
Refer to a pediatric cardiologist
For this reason and others, referral to a pediatric cardiologist is indicated instead of a consult with an adult cardiologist, Dr. Deal said. “You know how your kids will start with ‘no offense.’ Like, ‘no offense, Mom, but your hair looks awful.’ With moderate offense intended, having an adult cardiologist read a pediatric ECG and clear them is not adequate. They will be looking for ischemia or A-fib [atrial fibrillation]; they’re not looking for long QT syndrome, arrhythmogenic cardiomyopathy, or abnormal T waves.”
Early detection of long QT syndrome is optimal, Dr. Deal said, because symptom onset often is between infancy and age 7 years. In addition, mortality is highest in the first 2 decades of life. “I think this could be why adult cardiologists are not as concerned as we are,” Dr. Deal said. “The bad ones die before they reach adulthood.”
Ruling out a cardiac cause
The 2017 joint guideline defined syncope as a transient loss of consciousness. “By definition, you pass out, you’re not aware of where you are, and you cannot hear,” Dr. Deal said. If a patient reports they could hear people talking, they may have lost postural tone, but they did not have syncope, she added.
“Sometimes, we see teenagers who are said to pass out and are unresponsive for 5 minutes, 10 minutes, or 20 minutes. I’m usually relieved to hear that because that gets cardiac off the hook,” Dr. Deal said. “There is nothing cardiac that makes you pass out for 20 minutes, unless people are resuscitating you.” She added, “I’m not suggesting it’s not a significant problem that you need to get to the bottom of.”
Noncardiac etiologies can be neurologic, metabolic, drug-induced, or psychogenic. “This is where the detective work comes in.”
Keep clinical suspicion high for psychogenic syncope, Dr. Deal said. Psychogenic episodes stem from significant psychological stress, often something so profoundly bothersome that they cannot cope, such as sexual abuse.
A helpful tip for diagnosing the less worrisome vasovagal syncope is asking whether a patient was sitting to standing or standing a long time before an episode, Dr. Deal said. “A common complaint is that the family went to airport, got up early, didn’t eat, and ended up standing for a long time. Kids will say they don’t feel well, they fall down, and all hell breaks loose.” Other causes of vasovagal syncope include stress, pain, or a situational trigger, for example, when a person faints during a blood draw or immunization.
The 2017 guideline also set forth the evidence behind various medications used to lower the risk of syncope. However, Dr. Deal said, “If syncope only happens every 3 years when you go to an airport, it’s probably not worth daily therapy to prevent that.”
‘The world’s most boring test’
For the most part, lifestyle measures should work to address vasovagal syncope. A tilt table test can be useful to aid the differential diagnosis, but it’s recommended only when the etiology is unclear, Dr. Deal said. On the plus side, the tilt table test allows clinicians to reproduce symptoms in a controlled environment. On the downside, she added, “It’s the world’s most boring test. It’s a challenge for the cardiologist to stay awake. It’s very boring, until all hell breaks loose.”
“I find this helpful in the setting of kids with seizures and for kids with this atypical syncope where you just cannot convince the family that these 20-minute episodes of loss of consciousness are not near-death episodes.”
Dr. Deal had no relevant financial disclosures.
*This article was updated on 10/25/2017.
CHICAGO – Syncope often is misdiagnosed in pediatric patients complaining of chest pain, and a new guideline released in 2017 could guide clinicians toward a more accurate differential diagnosis and help them know when immediate referral to cardiology or the emergency department is warranted.
“There are recent guidelines published this year which are helpful,” said Dr. Barbara Deal, the Getz Professor of Cardiology at Northwestern University in Chicago. “,” which is defined as transient loss of consciousness.
“Once you establish it is a simple vasovagal [cause], you need to educate patients on conditions that would promote this and the need to be anticipatory,” Dr. Deal said at the annual meeting of the American Academy of Pediatrics. “Further testing with an echo[cardiogram] should be done if you suspect heart disease or a rhythm disorder.”
Chest pain and syncope are common complaints that can lead to significant anxiety for patients, parents, and pediatric providers. The greatest cause of this anxiety is the prospect of a fatal or near-fatal event. An abnormal cardiac examination, any associated palpitations, and a history of urinary incontinence or traumatic injury are reasons to worry, she said. “Any of these should prompt an urgent consult to cardiology or the emergency department.”
Cardiac causes of chest pain include reflex or vasovagal syncope or even a more serious cardiac cause, such as arrhythmic or structural issues, Dr. Deal said. Symptoms that appear with exertion or stress also are very worrisome. “You would know if they have a heart murmur or stenosis – it’s these other things that don’t present with a cardiac abnormality: hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy,” she said. “If they have symptoms on exertion, pay attention. This is not good.”
Syncope often is misdiagnosed, Dr. Deal said. Approximately 35%-48% of patients classified as having syncope do not have actual syncope;rather they experience dizziness rather than a loss of consciousness. In a study of 194 children, for example, the leading etiologies diagnosed after evaluation for syncope included simple fainting in 49%, a vasopressor/vasovagal response in 14%, and possible seizure in 14% (J Am Coll Cardiol. 1997;29[6]:1039-45). Seven percent were diagnosed with syncope not otherwise specified in this series. Some other causes included psychogenic or orthostatic ones, hyperventilation, dysmenorrhea, vertigo, dehydration, trauma, stress, exhaustion, or an infectious condition.*
“When should you be thinking life-threatening syncope?” Dr. Deal asked. Arrhythmic disorders that are heritable, such as an ion channelopathy, are an example. “They don’t always feel the racing heartbeat, but they feel something is not right; they feel a sense of impending doom. Some families report signs during exercise like swimming, seizures, gargling noises, or unusual symptoms on awakening.”
Dr. Deal noted that ages 3-24 years are “the problem territory for cardiac arrest.” In this age group, 43%-55% of cardiac arrests are associated with hypertrophic cardiomyopathy or arrhythmias; about one in three will have prior syncope. “These causes are not detectable on physical examination and often are not detectable with ECG only,” adding to the differential diagnosis challenges.*
Refer to a pediatric cardiologist
For this reason and others, referral to a pediatric cardiologist is indicated instead of a consult with an adult cardiologist, Dr. Deal said. “You know how your kids will start with ‘no offense.’ Like, ‘no offense, Mom, but your hair looks awful.’ With moderate offense intended, having an adult cardiologist read a pediatric ECG and clear them is not adequate. They will be looking for ischemia or A-fib [atrial fibrillation]; they’re not looking for long QT syndrome, arrhythmogenic cardiomyopathy, or abnormal T waves.”
Early detection of long QT syndrome is optimal, Dr. Deal said, because symptom onset often is between infancy and age 7 years. In addition, mortality is highest in the first 2 decades of life. “I think this could be why adult cardiologists are not as concerned as we are,” Dr. Deal said. “The bad ones die before they reach adulthood.”
Ruling out a cardiac cause
The 2017 joint guideline defined syncope as a transient loss of consciousness. “By definition, you pass out, you’re not aware of where you are, and you cannot hear,” Dr. Deal said. If a patient reports they could hear people talking, they may have lost postural tone, but they did not have syncope, she added.
“Sometimes, we see teenagers who are said to pass out and are unresponsive for 5 minutes, 10 minutes, or 20 minutes. I’m usually relieved to hear that because that gets cardiac off the hook,” Dr. Deal said. “There is nothing cardiac that makes you pass out for 20 minutes, unless people are resuscitating you.” She added, “I’m not suggesting it’s not a significant problem that you need to get to the bottom of.”
Noncardiac etiologies can be neurologic, metabolic, drug-induced, or psychogenic. “This is where the detective work comes in.”
Keep clinical suspicion high for psychogenic syncope, Dr. Deal said. Psychogenic episodes stem from significant psychological stress, often something so profoundly bothersome that they cannot cope, such as sexual abuse.
A helpful tip for diagnosing the less worrisome vasovagal syncope is asking whether a patient was sitting to standing or standing a long time before an episode, Dr. Deal said. “A common complaint is that the family went to airport, got up early, didn’t eat, and ended up standing for a long time. Kids will say they don’t feel well, they fall down, and all hell breaks loose.” Other causes of vasovagal syncope include stress, pain, or a situational trigger, for example, when a person faints during a blood draw or immunization.
The 2017 guideline also set forth the evidence behind various medications used to lower the risk of syncope. However, Dr. Deal said, “If syncope only happens every 3 years when you go to an airport, it’s probably not worth daily therapy to prevent that.”
‘The world’s most boring test’
For the most part, lifestyle measures should work to address vasovagal syncope. A tilt table test can be useful to aid the differential diagnosis, but it’s recommended only when the etiology is unclear, Dr. Deal said. On the plus side, the tilt table test allows clinicians to reproduce symptoms in a controlled environment. On the downside, she added, “It’s the world’s most boring test. It’s a challenge for the cardiologist to stay awake. It’s very boring, until all hell breaks loose.”
“I find this helpful in the setting of kids with seizures and for kids with this atypical syncope where you just cannot convince the family that these 20-minute episodes of loss of consciousness are not near-death episodes.”
Dr. Deal had no relevant financial disclosures.
*This article was updated on 10/25/2017.
EXPERT ANALYSIS FROM AAP 2017
VIDEO: Endoscopy surpasses surgery for acute necrotizing pancreatitis
ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.
Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.
This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.
Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.
Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).
The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.
The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.
The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.
Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.
This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.
Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.
Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).
The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.
The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.
The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.
Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.
This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.
Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.
Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).
The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.
The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.
The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Major adverse events occurred in 12% of patients treated endoscopically and in 38% of patients treated surgically.
Data source: MISER, a multicenter randomized study of 66 evaluable patients.
Disclosures: MISER received no commercial funding. Dr. Bang had no disclosures.
Exercise reduces T1DM mortality risk
LISBON – Exercise was associated with a lower risk of all-cause mortality in patients with type 1 diabetes mellitus, regardless of whether or not they also had chronic kidney disease, according to an analysis of data from a large ongoing population study.
Fully adjusted hazard ratios comparing low versus moderate-to-high amounts of physical activity, intensity, frequency, and duration were a respective 1.63, 2.17, 2.07, and 1.86 in patients without CKD.
The corresponding HRs in patients with comorbid CKD were 1.47, 1.39, 1.90, and 1.49, although only the total exercise amount and frequency were statistically significant in this study group.
“So far, we know little about exercise and mortality in type 1 diabetes in a prospective setting,” Dr. Tikkanen-Dolenc added. There have been two large studies – the Pittsburgh Study (Diabetes. 1984;33:271-6) and the EURODIAB study (Diabetologia. 2013;56:82-91) – that have been conducted previously. The first showed a benefit of greater participation in team sports and leisure time physical activity (LTPA) in men only, and the second showed a borderline inverse association between a higher amount of LTPA and mortality in both sexes, she said. There are even fewer data specifically in patients with comorbid CKD, although exercise is recommended and appears to be safe, she said.
Dr. Tikkanen-Dolenc and her associates have previously shown that diabetic nephropathy largely accounts for the increased mortality risk in T1DM (Diabetes. 2009;58:1651-8), and that the intensity of exercise rather than the total amount could be important (Diabetologia. 2015;58:929-36). They have also found that high intensity and frequency of LTPA was associated with a decreased risk of cardiovascular events in patients with T1DM (Diabetologia. 2017;60:574-80). Now, they wanted to look more specifically at how LTPA might be associated with mortality in T1DM and also do a separate investigation of what happens when there is concomitant loss of kidney function.
Patients included in the analysis were part of the Finnish Diabetic Nephropathy (FinnDiane) Study, which is a nationwide study being conducted in 90 centers in Finland to look for risk factors and mechanisms behind diabetic complications. To date, the study involves around 5,000 participants, and 2,369 were included in the present analysis. Of these, 310 also had CKD, which was defined by an estimated glomerular filtration rate of 60 mL/min per 1.73 m2 or lower.
A previously validated questionnaire was used to measure LTPA. The total LTPA was calculated by measuring the time spent doing an activity by the intensity index expressed in metabolic equivalents (MET). The latter is a widely used unit in exercise research, Dr. Tikkanen-Dolenc said, and gives a measure of the ratio of the metabolic rate during activity to the rate at rest.
Over a follow-up of 11 years, 270 patients died and 2,099 were alive. Patients who died were significantly (P less than .001) older (50 vs. 38 years), had a longer duration of diabetes (33 vs. 22 years), higher systolic blood pressure (146 vs. 134 mm Hg), lower high-density lipoprotein cholesterol (1.38 vs. 1.44 mmol/L), and higher triglycerides (1.25 vs. 0.96 mmol/L). They were also more sedentary, with baseline LTPAs of 8.6 versus 17.2 MET/h (P less than .001). These factors were taken into account while analyzing the data in multiple ways for static and dynamic risk factors.
“These are great data, and this is one of the best clinical studies at the meeting,” observed Viktor Jörgens, MD, former executive director of the EASD and of the European Foundation for the Study of Diabetes, during the post-presentation discussion.
Dr. Jörgens suggested, however, that there was perhaps one important caveat before doctors around the globe started encouraging their patients to exercise more: the level of patient education around the risk for severe hypoglycemia with increasing exercise and routine availability of blood glucose monitoring.
“The problem with severe exercise in type 1 is severe hypoglycemia, and I know Finland is one of the leading countries for patient education and intensified insulin therapy,” Dr. Jörgens cautioned. “Therefore I assume that most of your patients were well educated on blood glucose monitoring, and knew everything about exercise and reducing the dosage [of insulin therapy].” Not all countries may have such high levels of patient education of monitoring, he suggested.
Dr. Tikkanen-Dolenc responded that “of course patient education is needed, such as on continuous glucose monitoring, and there is a risk, but when we look to current recommendations, we still do recommend exercise, even in type 1 diabetes, and it appears to be safe, but that’s a good point and that’s something we need to note.”
Neither Dr. Tikkanen-Dolenc or Dr. Jörgens had anything to disclose.
LISBON – Exercise was associated with a lower risk of all-cause mortality in patients with type 1 diabetes mellitus, regardless of whether or not they also had chronic kidney disease, according to an analysis of data from a large ongoing population study.
Fully adjusted hazard ratios comparing low versus moderate-to-high amounts of physical activity, intensity, frequency, and duration were a respective 1.63, 2.17, 2.07, and 1.86 in patients without CKD.
The corresponding HRs in patients with comorbid CKD were 1.47, 1.39, 1.90, and 1.49, although only the total exercise amount and frequency were statistically significant in this study group.
“So far, we know little about exercise and mortality in type 1 diabetes in a prospective setting,” Dr. Tikkanen-Dolenc added. There have been two large studies – the Pittsburgh Study (Diabetes. 1984;33:271-6) and the EURODIAB study (Diabetologia. 2013;56:82-91) – that have been conducted previously. The first showed a benefit of greater participation in team sports and leisure time physical activity (LTPA) in men only, and the second showed a borderline inverse association between a higher amount of LTPA and mortality in both sexes, she said. There are even fewer data specifically in patients with comorbid CKD, although exercise is recommended and appears to be safe, she said.
Dr. Tikkanen-Dolenc and her associates have previously shown that diabetic nephropathy largely accounts for the increased mortality risk in T1DM (Diabetes. 2009;58:1651-8), and that the intensity of exercise rather than the total amount could be important (Diabetologia. 2015;58:929-36). They have also found that high intensity and frequency of LTPA was associated with a decreased risk of cardiovascular events in patients with T1DM (Diabetologia. 2017;60:574-80). Now, they wanted to look more specifically at how LTPA might be associated with mortality in T1DM and also do a separate investigation of what happens when there is concomitant loss of kidney function.
Patients included in the analysis were part of the Finnish Diabetic Nephropathy (FinnDiane) Study, which is a nationwide study being conducted in 90 centers in Finland to look for risk factors and mechanisms behind diabetic complications. To date, the study involves around 5,000 participants, and 2,369 were included in the present analysis. Of these, 310 also had CKD, which was defined by an estimated glomerular filtration rate of 60 mL/min per 1.73 m2 or lower.
A previously validated questionnaire was used to measure LTPA. The total LTPA was calculated by measuring the time spent doing an activity by the intensity index expressed in metabolic equivalents (MET). The latter is a widely used unit in exercise research, Dr. Tikkanen-Dolenc said, and gives a measure of the ratio of the metabolic rate during activity to the rate at rest.
Over a follow-up of 11 years, 270 patients died and 2,099 were alive. Patients who died were significantly (P less than .001) older (50 vs. 38 years), had a longer duration of diabetes (33 vs. 22 years), higher systolic blood pressure (146 vs. 134 mm Hg), lower high-density lipoprotein cholesterol (1.38 vs. 1.44 mmol/L), and higher triglycerides (1.25 vs. 0.96 mmol/L). They were also more sedentary, with baseline LTPAs of 8.6 versus 17.2 MET/h (P less than .001). These factors were taken into account while analyzing the data in multiple ways for static and dynamic risk factors.
“These are great data, and this is one of the best clinical studies at the meeting,” observed Viktor Jörgens, MD, former executive director of the EASD and of the European Foundation for the Study of Diabetes, during the post-presentation discussion.
Dr. Jörgens suggested, however, that there was perhaps one important caveat before doctors around the globe started encouraging their patients to exercise more: the level of patient education around the risk for severe hypoglycemia with increasing exercise and routine availability of blood glucose monitoring.
“The problem with severe exercise in type 1 is severe hypoglycemia, and I know Finland is one of the leading countries for patient education and intensified insulin therapy,” Dr. Jörgens cautioned. “Therefore I assume that most of your patients were well educated on blood glucose monitoring, and knew everything about exercise and reducing the dosage [of insulin therapy].” Not all countries may have such high levels of patient education of monitoring, he suggested.
Dr. Tikkanen-Dolenc responded that “of course patient education is needed, such as on continuous glucose monitoring, and there is a risk, but when we look to current recommendations, we still do recommend exercise, even in type 1 diabetes, and it appears to be safe, but that’s a good point and that’s something we need to note.”
Neither Dr. Tikkanen-Dolenc or Dr. Jörgens had anything to disclose.
LISBON – Exercise was associated with a lower risk of all-cause mortality in patients with type 1 diabetes mellitus, regardless of whether or not they also had chronic kidney disease, according to an analysis of data from a large ongoing population study.
Fully adjusted hazard ratios comparing low versus moderate-to-high amounts of physical activity, intensity, frequency, and duration were a respective 1.63, 2.17, 2.07, and 1.86 in patients without CKD.
The corresponding HRs in patients with comorbid CKD were 1.47, 1.39, 1.90, and 1.49, although only the total exercise amount and frequency were statistically significant in this study group.
“So far, we know little about exercise and mortality in type 1 diabetes in a prospective setting,” Dr. Tikkanen-Dolenc added. There have been two large studies – the Pittsburgh Study (Diabetes. 1984;33:271-6) and the EURODIAB study (Diabetologia. 2013;56:82-91) – that have been conducted previously. The first showed a benefit of greater participation in team sports and leisure time physical activity (LTPA) in men only, and the second showed a borderline inverse association between a higher amount of LTPA and mortality in both sexes, she said. There are even fewer data specifically in patients with comorbid CKD, although exercise is recommended and appears to be safe, she said.
Dr. Tikkanen-Dolenc and her associates have previously shown that diabetic nephropathy largely accounts for the increased mortality risk in T1DM (Diabetes. 2009;58:1651-8), and that the intensity of exercise rather than the total amount could be important (Diabetologia. 2015;58:929-36). They have also found that high intensity and frequency of LTPA was associated with a decreased risk of cardiovascular events in patients with T1DM (Diabetologia. 2017;60:574-80). Now, they wanted to look more specifically at how LTPA might be associated with mortality in T1DM and also do a separate investigation of what happens when there is concomitant loss of kidney function.
Patients included in the analysis were part of the Finnish Diabetic Nephropathy (FinnDiane) Study, which is a nationwide study being conducted in 90 centers in Finland to look for risk factors and mechanisms behind diabetic complications. To date, the study involves around 5,000 participants, and 2,369 were included in the present analysis. Of these, 310 also had CKD, which was defined by an estimated glomerular filtration rate of 60 mL/min per 1.73 m2 or lower.
A previously validated questionnaire was used to measure LTPA. The total LTPA was calculated by measuring the time spent doing an activity by the intensity index expressed in metabolic equivalents (MET). The latter is a widely used unit in exercise research, Dr. Tikkanen-Dolenc said, and gives a measure of the ratio of the metabolic rate during activity to the rate at rest.
Over a follow-up of 11 years, 270 patients died and 2,099 were alive. Patients who died were significantly (P less than .001) older (50 vs. 38 years), had a longer duration of diabetes (33 vs. 22 years), higher systolic blood pressure (146 vs. 134 mm Hg), lower high-density lipoprotein cholesterol (1.38 vs. 1.44 mmol/L), and higher triglycerides (1.25 vs. 0.96 mmol/L). They were also more sedentary, with baseline LTPAs of 8.6 versus 17.2 MET/h (P less than .001). These factors were taken into account while analyzing the data in multiple ways for static and dynamic risk factors.
“These are great data, and this is one of the best clinical studies at the meeting,” observed Viktor Jörgens, MD, former executive director of the EASD and of the European Foundation for the Study of Diabetes, during the post-presentation discussion.
Dr. Jörgens suggested, however, that there was perhaps one important caveat before doctors around the globe started encouraging their patients to exercise more: the level of patient education around the risk for severe hypoglycemia with increasing exercise and routine availability of blood glucose monitoring.
“The problem with severe exercise in type 1 is severe hypoglycemia, and I know Finland is one of the leading countries for patient education and intensified insulin therapy,” Dr. Jörgens cautioned. “Therefore I assume that most of your patients were well educated on blood glucose monitoring, and knew everything about exercise and reducing the dosage [of insulin therapy].” Not all countries may have such high levels of patient education of monitoring, he suggested.
Dr. Tikkanen-Dolenc responded that “of course patient education is needed, such as on continuous glucose monitoring, and there is a risk, but when we look to current recommendations, we still do recommend exercise, even in type 1 diabetes, and it appears to be safe, but that’s a good point and that’s something we need to note.”
Neither Dr. Tikkanen-Dolenc or Dr. Jörgens had anything to disclose.
AT EASD 2017
Key clinical point: Exercise was associated with a lower risk of all-cause mortality in patients with type 1 diabetes mellitus, even in those with chronic kidney disease.
Major finding: Increasing exercise intensity and frequency was inversely associated with increased mortality in patients with T1DM and CKD (hazard ratios, 1.47 and 1.90, respectively).
Data source: The Finnish Diabetic Nephropathy Study; 2,369 patients with T1DM were included in the analyses.
Disclosures: The presenting author and commentator had no disclosures.
MI, stroke risk from HFrEF surpasses HFpEF
DALLAS – Patients newly diagnosed with heart failure with reduced ejection fraction had about an 8% incidence of MIs during the subsequent 9 months, and a 5% incidence of ischemic strokes in a retrospective review of more than 1,600 community-dwelling U.S. patients.
The MI and ischemic stroke incidence rates in heart failure patients with reduced ejection fraction (HFrEF) were both significantly higher than in more than 4,000 patients with heart failure with preserved ejection fraction (HFpEF), Gregg C. Fonarow, MD, said while presenting a poster at the annual scientific meeting of the Heart Failure Society of America.
The findings suggest that greater attention is needed to reduce the risks for MI and stroke in HFrEF patients, suggested Dr. Fonarow, professor and cochief of cardiology at the University of California, Los Angeles, and his associates in their poster.
The study used claims data collected during July 2009-September 2016 from more than 10 million people enrolled in the United Health Group, who received care at more than 650 hospitals and about 6,600 clinics. The study included all patients diagnosed with heart failure during a hospital or emergency room visit and who had no history of a heart failure diagnosis or episode during the preceding 18 months, a left ventricular ejection fraction measurement made close to the time of the index encounter, and no stroke or MI apparent at the time of the index event. The study included 1,622 patients with HFrEF, defined as a left ventricular ejection fraction of less than 40%, 4,288 with HFpEF, defined as an ejection fraction of 50% or more, and 1,095 with heart failure with a borderline ejection fraction of 40%-49%.
The HFrEF patients had an average ejection fraction of 28%, they averaged 72 years old, 36% were women, and 8% had a prior stroke. The HFpEF patients averaged 74 years old, their average ejection fraction was 61%, 55% were women, and 11% had a prior stroke. Follow-up data on all patients were available for an average of nearly 9 months following their index heart failure event, with some patients followed as long as 1 year.
During follow-up, the incidence of ischemic stroke was 5.4% in the HFrEF patients and 3.9% in those with HFpEF, a difference that worked out to a statistically significant 40% higher ischemic stroke rate in HFrEF patients after adjustment for baseline differences between the two patient groups, Dr. Fonarow reported. The patients with a borderline ejection fraction had a 3.7% stroke incidence that fell short of a significant difference, compared with the HFrEF patient.The rate of new MIs during follow-up was 7.5% in the HFrEF patients and 3.2% in the HFpEF patients, a statistically significant 2.5-fold relatively higher MI rate with HFrEF, a statistically significant difference after adjustments. The MI incidence in patients with a borderline ejection fraction was 5.9%
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On Twitter @mitchelzoler
DALLAS – Patients newly diagnosed with heart failure with reduced ejection fraction had about an 8% incidence of MIs during the subsequent 9 months, and a 5% incidence of ischemic strokes in a retrospective review of more than 1,600 community-dwelling U.S. patients.
The MI and ischemic stroke incidence rates in heart failure patients with reduced ejection fraction (HFrEF) were both significantly higher than in more than 4,000 patients with heart failure with preserved ejection fraction (HFpEF), Gregg C. Fonarow, MD, said while presenting a poster at the annual scientific meeting of the Heart Failure Society of America.
The findings suggest that greater attention is needed to reduce the risks for MI and stroke in HFrEF patients, suggested Dr. Fonarow, professor and cochief of cardiology at the University of California, Los Angeles, and his associates in their poster.
The study used claims data collected during July 2009-September 2016 from more than 10 million people enrolled in the United Health Group, who received care at more than 650 hospitals and about 6,600 clinics. The study included all patients diagnosed with heart failure during a hospital or emergency room visit and who had no history of a heart failure diagnosis or episode during the preceding 18 months, a left ventricular ejection fraction measurement made close to the time of the index encounter, and no stroke or MI apparent at the time of the index event. The study included 1,622 patients with HFrEF, defined as a left ventricular ejection fraction of less than 40%, 4,288 with HFpEF, defined as an ejection fraction of 50% or more, and 1,095 with heart failure with a borderline ejection fraction of 40%-49%.
The HFrEF patients had an average ejection fraction of 28%, they averaged 72 years old, 36% were women, and 8% had a prior stroke. The HFpEF patients averaged 74 years old, their average ejection fraction was 61%, 55% were women, and 11% had a prior stroke. Follow-up data on all patients were available for an average of nearly 9 months following their index heart failure event, with some patients followed as long as 1 year.
During follow-up, the incidence of ischemic stroke was 5.4% in the HFrEF patients and 3.9% in those with HFpEF, a difference that worked out to a statistically significant 40% higher ischemic stroke rate in HFrEF patients after adjustment for baseline differences between the two patient groups, Dr. Fonarow reported. The patients with a borderline ejection fraction had a 3.7% stroke incidence that fell short of a significant difference, compared with the HFrEF patient.The rate of new MIs during follow-up was 7.5% in the HFrEF patients and 3.2% in the HFpEF patients, a statistically significant 2.5-fold relatively higher MI rate with HFrEF, a statistically significant difference after adjustments. The MI incidence in patients with a borderline ejection fraction was 5.9%
[email protected]
On Twitter @mitchelzoler
DALLAS – Patients newly diagnosed with heart failure with reduced ejection fraction had about an 8% incidence of MIs during the subsequent 9 months, and a 5% incidence of ischemic strokes in a retrospective review of more than 1,600 community-dwelling U.S. patients.
The MI and ischemic stroke incidence rates in heart failure patients with reduced ejection fraction (HFrEF) were both significantly higher than in more than 4,000 patients with heart failure with preserved ejection fraction (HFpEF), Gregg C. Fonarow, MD, said while presenting a poster at the annual scientific meeting of the Heart Failure Society of America.
The findings suggest that greater attention is needed to reduce the risks for MI and stroke in HFrEF patients, suggested Dr. Fonarow, professor and cochief of cardiology at the University of California, Los Angeles, and his associates in their poster.
The study used claims data collected during July 2009-September 2016 from more than 10 million people enrolled in the United Health Group, who received care at more than 650 hospitals and about 6,600 clinics. The study included all patients diagnosed with heart failure during a hospital or emergency room visit and who had no history of a heart failure diagnosis or episode during the preceding 18 months, a left ventricular ejection fraction measurement made close to the time of the index encounter, and no stroke or MI apparent at the time of the index event. The study included 1,622 patients with HFrEF, defined as a left ventricular ejection fraction of less than 40%, 4,288 with HFpEF, defined as an ejection fraction of 50% or more, and 1,095 with heart failure with a borderline ejection fraction of 40%-49%.
The HFrEF patients had an average ejection fraction of 28%, they averaged 72 years old, 36% were women, and 8% had a prior stroke. The HFpEF patients averaged 74 years old, their average ejection fraction was 61%, 55% were women, and 11% had a prior stroke. Follow-up data on all patients were available for an average of nearly 9 months following their index heart failure event, with some patients followed as long as 1 year.
During follow-up, the incidence of ischemic stroke was 5.4% in the HFrEF patients and 3.9% in those with HFpEF, a difference that worked out to a statistically significant 40% higher ischemic stroke rate in HFrEF patients after adjustment for baseline differences between the two patient groups, Dr. Fonarow reported. The patients with a borderline ejection fraction had a 3.7% stroke incidence that fell short of a significant difference, compared with the HFrEF patient.The rate of new MIs during follow-up was 7.5% in the HFrEF patients and 3.2% in the HFpEF patients, a statistically significant 2.5-fold relatively higher MI rate with HFrEF, a statistically significant difference after adjustments. The MI incidence in patients with a borderline ejection fraction was 5.9%
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: HFrEF patients had a 40% higher incidence of stroke and a 2.5-fold higher incidence of MI, compared with HFpEF patients.
Data source: Retrospective review of 7,005 U.S. patients newly diagnosed with heart failure.
Disclosures: The study was funded by Janssen. Dr. Fonarow had no relevant disclosures.