Allowed Publications
LayerRx Mapping ID
341
Slot System
Featured Buckets
Featured Buckets Admin
Medscape Lead Concept
64646

Heart failure hospitalizations jump after major holidays

Article Type
Changed
Fri, 01/18/2019 - 14:04
Display Headline
Heart failure hospitalizations jump after major holidays

LAS VEGAS – Ah, Christmas. The lights, the good cheer, the presents under the tree. And something extra: a 14% bump in heart failure hospitalizations in the days that follow.

“Holiday heart” is a real phenomenon among patients with heart failure, Dr. Mahek Shah reported at the annual meeting of the Heart Failure Society of America.

Overindulgence may wreak havoc with extracellular fluid volume.
© photo4u2/Thinkstock
Overindulgence may wreak havoc with extracellular fluid volume.

He and his coinvestigators retrospectively analyzed the records of all 22,728 patients admitted for heart failure to Einstein Medical Center in Philadelphia in a recent 10-year period. The purpose was to learn if admission rates climbed in conjunction with national holidays, as has previously been reported for acute MI.

Sure enough, the mean daily admission rate for heart failure was 6.5 cases per day for Dec. 26-29, compared with 5.7 per day during the rest of the month. That’s a 14% jump.

Similarly, the mean daily heart failure admission rate was 11.4% greater during July 5-8 than in the rest of July, and 11% higher on the 4 days following Super Bowl Sunday than the rest of that month. Daily admissions rose by 3.3% on Jan. 2-5, compared with the rest of January, and by 2% on the 4 days following Thanksgiving, compared with the daily average for the rest of November, according to Dr. Shah of Einstein Medical Center.

Mean lengths of stay, however, weren’t significantly different for patients admitted in the 4 days post holiday than in the rest of the month, he added.

Dr. Shah offered two hypotheses for the holiday heart hospitalization phenomenon that he and his colleagues documented. One, it’s likely that many heart failure patients – just like the rest of America – overindulge in rich, salty foods at holiday celebrations that, in the case of individuals with heart failure, wreaks havoc with their extracellular fluid volume. Second, some heart failure patients probably delay in seeking medical care at holiday time because they don’t want to miss or spoil the party.

Dr. Shah reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

References

Click for Credit Link
Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
heart failure, holiday heart, hospitalization
Click for Credit Link
Click for Credit Link
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

LAS VEGAS – Ah, Christmas. The lights, the good cheer, the presents under the tree. And something extra: a 14% bump in heart failure hospitalizations in the days that follow.

“Holiday heart” is a real phenomenon among patients with heart failure, Dr. Mahek Shah reported at the annual meeting of the Heart Failure Society of America.

Overindulgence may wreak havoc with extracellular fluid volume.
© photo4u2/Thinkstock
Overindulgence may wreak havoc with extracellular fluid volume.

He and his coinvestigators retrospectively analyzed the records of all 22,728 patients admitted for heart failure to Einstein Medical Center in Philadelphia in a recent 10-year period. The purpose was to learn if admission rates climbed in conjunction with national holidays, as has previously been reported for acute MI.

Sure enough, the mean daily admission rate for heart failure was 6.5 cases per day for Dec. 26-29, compared with 5.7 per day during the rest of the month. That’s a 14% jump.

Similarly, the mean daily heart failure admission rate was 11.4% greater during July 5-8 than in the rest of July, and 11% higher on the 4 days following Super Bowl Sunday than the rest of that month. Daily admissions rose by 3.3% on Jan. 2-5, compared with the rest of January, and by 2% on the 4 days following Thanksgiving, compared with the daily average for the rest of November, according to Dr. Shah of Einstein Medical Center.

Mean lengths of stay, however, weren’t significantly different for patients admitted in the 4 days post holiday than in the rest of the month, he added.

Dr. Shah offered two hypotheses for the holiday heart hospitalization phenomenon that he and his colleagues documented. One, it’s likely that many heart failure patients – just like the rest of America – overindulge in rich, salty foods at holiday celebrations that, in the case of individuals with heart failure, wreaks havoc with their extracellular fluid volume. Second, some heart failure patients probably delay in seeking medical care at holiday time because they don’t want to miss or spoil the party.

Dr. Shah reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

LAS VEGAS – Ah, Christmas. The lights, the good cheer, the presents under the tree. And something extra: a 14% bump in heart failure hospitalizations in the days that follow.

“Holiday heart” is a real phenomenon among patients with heart failure, Dr. Mahek Shah reported at the annual meeting of the Heart Failure Society of America.

Overindulgence may wreak havoc with extracellular fluid volume.
© photo4u2/Thinkstock
Overindulgence may wreak havoc with extracellular fluid volume.

He and his coinvestigators retrospectively analyzed the records of all 22,728 patients admitted for heart failure to Einstein Medical Center in Philadelphia in a recent 10-year period. The purpose was to learn if admission rates climbed in conjunction with national holidays, as has previously been reported for acute MI.

Sure enough, the mean daily admission rate for heart failure was 6.5 cases per day for Dec. 26-29, compared with 5.7 per day during the rest of the month. That’s a 14% jump.

Similarly, the mean daily heart failure admission rate was 11.4% greater during July 5-8 than in the rest of July, and 11% higher on the 4 days following Super Bowl Sunday than the rest of that month. Daily admissions rose by 3.3% on Jan. 2-5, compared with the rest of January, and by 2% on the 4 days following Thanksgiving, compared with the daily average for the rest of November, according to Dr. Shah of Einstein Medical Center.

Mean lengths of stay, however, weren’t significantly different for patients admitted in the 4 days post holiday than in the rest of the month, he added.

Dr. Shah offered two hypotheses for the holiday heart hospitalization phenomenon that he and his colleagues documented. One, it’s likely that many heart failure patients – just like the rest of America – overindulge in rich, salty foods at holiday celebrations that, in the case of individuals with heart failure, wreaks havoc with their extracellular fluid volume. Second, some heart failure patients probably delay in seeking medical care at holiday time because they don’t want to miss or spoil the party.

Dr. Shah reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
Heart failure hospitalizations jump after major holidays
Display Headline
Heart failure hospitalizations jump after major holidays
Legacy Keywords
heart failure, holiday heart, hospitalization
Legacy Keywords
heart failure, holiday heart, hospitalization
Article Source

AT THE HFSA ANNUAL SCIENTIFIC MEETING

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Expect a noticeable spike in hospitalizations for heart failure in the 4 days following major national holidays such as Christmas, the Fourth of July, or the Super Bowl.

Major finding: Daily hospitalization rates for heart failure climb by 14% during the 4 days after Christmas and by 11% following Super Bowl Sunday and on July 5-8, compared with the daily rates or the rest of those months.

Data source: Review of daily admission rates for nearly 23,000 patients hospitalized for heart failure during a decade-long period at a large medical center.

Disclosures: Dr. Shah reported having no financial conflicts regarding this study.

Heart failure readmission cuts may be a phone call away

Article Type
Changed
Fri, 12/07/2018 - 20:23
Display Headline
Heart failure readmission cuts may be a phone call away

LAS VEGAS – A structured follow-up telephone call to heart failure patients made within 48 hours post discharge can reduce 30-day readmissions by fully one-half to two-thirds.

That’s been the experience at Stanford (Calif.) University Medical Center, where the 30-day heart failure readmission rate dropped from 20% in 524 patients at baseline to 10% among 341 patients discharged since the follow-up phone call practice was introduced, clinical nurse specialist Christine Thompson reported at the annual meeting of the Heart Failure Society of America.

The telephone follow-up call was just one element in a set of interventions developed by a multidisciplinary team.
© Dron - Fotolia.com
The telephone follow-up call was just one element in a set of interventions developed by a multidisciplinary team.

The telephone call follows a scripted template embedded in the patient’s electronic health record. The template incorporates “smart text” questions that assist in identifying gaps in patient care. For example, when Ms. Thompson or another caller asks, “How have you been feeling since discharge?” it provides an opportunity to review the typical symptoms of heart failure and make sure the patient knows how to recognize them.

Other questions review medications and address the patient’s activity level, adherence to the recommended low-sodium diet, and self-weighing at home with tracking of the results. The interviewer also makes sure the patient knows his or her physician’s name, phone number, the date of the next scheduled appointment, and understands the circumstances when it’s important to call the doctor because the clinical picture is beginning to deteriorate, explained Ms. Thompson, who works in the Stanford heart failure program.

The structured telephone follow-up call was merely one element of a whole set of interventions developed by a multidisciplinary Stanford team in an effort to reduce heart failure readmissions. Other interventions included medication reconciliation, routinely scheduling an early postdischarge clinic visit, and an increased emphasis upon patient education using patient “teach back” techniques to promote mastery of key information.

In the first 14 months since the full readmission-reduction program was launched, 96% of patients reached via a postdischarge phone call demonstrated that they understood their discharge medications and how to take them.

It was possible to determine the specific contribution that the early postdischarge phone call made to the observed sharp decrease in 30-day readmissions because 61 patients didn’t get the follow-up phone call but did receive the other interventions. Their 30-day readmission rate was 28%, compared with 10% in those who did get the phone call, which translates to a 66% relative risk reduction. In a multivariate logistic regression analysis adjusted for the other interventions as well as patient age, sex, marital status, length of stay, and discharge destination, the early postdischarge follow-up phone call was independently associated with a 72% reduction in the risk of readmission within 30 days, according to Ms. Thompson.

She reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

References

Click for Credit Link
Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
30-day heart failure readmission medicare penalities
Click for Credit Link
Click for Credit Link
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

LAS VEGAS – A structured follow-up telephone call to heart failure patients made within 48 hours post discharge can reduce 30-day readmissions by fully one-half to two-thirds.

That’s been the experience at Stanford (Calif.) University Medical Center, where the 30-day heart failure readmission rate dropped from 20% in 524 patients at baseline to 10% among 341 patients discharged since the follow-up phone call practice was introduced, clinical nurse specialist Christine Thompson reported at the annual meeting of the Heart Failure Society of America.

The telephone follow-up call was just one element in a set of interventions developed by a multidisciplinary team.
© Dron - Fotolia.com
The telephone follow-up call was just one element in a set of interventions developed by a multidisciplinary team.

The telephone call follows a scripted template embedded in the patient’s electronic health record. The template incorporates “smart text” questions that assist in identifying gaps in patient care. For example, when Ms. Thompson or another caller asks, “How have you been feeling since discharge?” it provides an opportunity to review the typical symptoms of heart failure and make sure the patient knows how to recognize them.

Other questions review medications and address the patient’s activity level, adherence to the recommended low-sodium diet, and self-weighing at home with tracking of the results. The interviewer also makes sure the patient knows his or her physician’s name, phone number, the date of the next scheduled appointment, and understands the circumstances when it’s important to call the doctor because the clinical picture is beginning to deteriorate, explained Ms. Thompson, who works in the Stanford heart failure program.

The structured telephone follow-up call was merely one element of a whole set of interventions developed by a multidisciplinary Stanford team in an effort to reduce heart failure readmissions. Other interventions included medication reconciliation, routinely scheduling an early postdischarge clinic visit, and an increased emphasis upon patient education using patient “teach back” techniques to promote mastery of key information.

In the first 14 months since the full readmission-reduction program was launched, 96% of patients reached via a postdischarge phone call demonstrated that they understood their discharge medications and how to take them.

It was possible to determine the specific contribution that the early postdischarge phone call made to the observed sharp decrease in 30-day readmissions because 61 patients didn’t get the follow-up phone call but did receive the other interventions. Their 30-day readmission rate was 28%, compared with 10% in those who did get the phone call, which translates to a 66% relative risk reduction. In a multivariate logistic regression analysis adjusted for the other interventions as well as patient age, sex, marital status, length of stay, and discharge destination, the early postdischarge follow-up phone call was independently associated with a 72% reduction in the risk of readmission within 30 days, according to Ms. Thompson.

She reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

LAS VEGAS – A structured follow-up telephone call to heart failure patients made within 48 hours post discharge can reduce 30-day readmissions by fully one-half to two-thirds.

That’s been the experience at Stanford (Calif.) University Medical Center, where the 30-day heart failure readmission rate dropped from 20% in 524 patients at baseline to 10% among 341 patients discharged since the follow-up phone call practice was introduced, clinical nurse specialist Christine Thompson reported at the annual meeting of the Heart Failure Society of America.

The telephone follow-up call was just one element in a set of interventions developed by a multidisciplinary team.
© Dron - Fotolia.com
The telephone follow-up call was just one element in a set of interventions developed by a multidisciplinary team.

The telephone call follows a scripted template embedded in the patient’s electronic health record. The template incorporates “smart text” questions that assist in identifying gaps in patient care. For example, when Ms. Thompson or another caller asks, “How have you been feeling since discharge?” it provides an opportunity to review the typical symptoms of heart failure and make sure the patient knows how to recognize them.

Other questions review medications and address the patient’s activity level, adherence to the recommended low-sodium diet, and self-weighing at home with tracking of the results. The interviewer also makes sure the patient knows his or her physician’s name, phone number, the date of the next scheduled appointment, and understands the circumstances when it’s important to call the doctor because the clinical picture is beginning to deteriorate, explained Ms. Thompson, who works in the Stanford heart failure program.

The structured telephone follow-up call was merely one element of a whole set of interventions developed by a multidisciplinary Stanford team in an effort to reduce heart failure readmissions. Other interventions included medication reconciliation, routinely scheduling an early postdischarge clinic visit, and an increased emphasis upon patient education using patient “teach back” techniques to promote mastery of key information.

In the first 14 months since the full readmission-reduction program was launched, 96% of patients reached via a postdischarge phone call demonstrated that they understood their discharge medications and how to take them.

It was possible to determine the specific contribution that the early postdischarge phone call made to the observed sharp decrease in 30-day readmissions because 61 patients didn’t get the follow-up phone call but did receive the other interventions. Their 30-day readmission rate was 28%, compared with 10% in those who did get the phone call, which translates to a 66% relative risk reduction. In a multivariate logistic regression analysis adjusted for the other interventions as well as patient age, sex, marital status, length of stay, and discharge destination, the early postdischarge follow-up phone call was independently associated with a 72% reduction in the risk of readmission within 30 days, according to Ms. Thompson.

She reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
Heart failure readmission cuts may be a phone call away
Display Headline
Heart failure readmission cuts may be a phone call away
Legacy Keywords
30-day heart failure readmission medicare penalities
Legacy Keywords
30-day heart failure readmission medicare penalities
Article Source

AT THE HFSA ANNUAL SCIENTIFIC MEETING

PURLs Copyright

Inside the Article

Vitals

Key clinical point: A phone call within 48 hours of discharge cut 30-day readmission rates for heart failure.

Major finding: The follow-up phone call was independently associated with a 72% reduction in risk.

Data source: This was a retrospective single-center analysis of prospectively collected data on heart failure readmissions before and after introduction of a scripted telephone follow-up call.

Disclosures: The presenter reported having no financial conflicts regarding this study.

Myocardial geometry, function altered in obese children

Article Type
Changed
Fri, 01/18/2019 - 14:03
Display Headline
Myocardial geometry, function altered in obese children

Obese children and adolescents show significant adverse alterations in myocardial geometry and function on echocardiography, compared with normal-weight children, according to a report published online Oct. 8 in JACC: Cardiovascular Imaging.

In a prospective, cross-sectional cohort study in Germany, researchers performed two-dimensional echocardiography in 61 obese and 40 nonobese participants aged 8-21 years. All the children were white, free of known disease, and not taking any medications, said Dr. Norman Mangner of the University of Leipzig and Heart Center Leipzig and his associates.

Dr. Norman Mangner
Dr. Norman Mangner

Global ejection fraction was normal in both study groups. However, the obese participants showed thickened LV walls and larger chamber dimensions; as a result, their calculated LV mass and LV mass index were roughly 40% higher than those of nonobese children. Left atrial volume, LA volume index, right atrial area, and right ventricular diameter all were also increased, compared with those of nonobese children. In addition, z scores for LA diameter were above the 95th percentile in a significantly higher percentage of the obese participants (33.3%) than nonobese participants (10%), the investigators said (J. Am. Coll. Cardiol. Img. 2014 Oct. 8 [doi: 10.1016/j.jcmg.2014.08.006]).

Regarding myocardial function, both tissue Doppler-derived peak systolic velocity and deformation in the basoseptal region were reduced in the obese children. Average longitudinal LV strain, strain rate, and displacement – all measures of longitudinal function – were significantly reduced. Average LV circumferential strain was significantly blunted in the obese participants, but the average LV circumferential strain rate and radial function were not significantly different between the two study groups. And diastolic function was decreased in the obese children, as evidenced by their reduced mitral E- to mitral A-wave peak velocity (E/A ratio), reduced mitral annulus tissue Doppler imaging (TDI) peak E-wave velocity, and increased E/E’ ratios.

“It is important to note that [these changes] do not necessarily translate into clinically relevant functional impairment,” Dr. Mangner and his associates said.

A longitudinal study is needed to clarify the clinical significance of these alterations and to explore whether weight loss will reverse them, they added.

This study was supported in part by grants from the German Research Foundation and the Clinical Research Group. One of Dr. Mangner’s associates reported ties to Medtronic, St. Jude Medical, Claret Medical, Boston Scientific, and Edwards; Dr. Mangner and his other associates reported having no financial disclosures.

References

Click for Credit Link
Author and Disclosure Information

Publications
Topics
Legacy Keywords
Obese children, adolescents, myocardial geometry, echocardiography, obesity
Click for Credit Link
Click for Credit Link
Author and Disclosure Information

Author and Disclosure Information

Obese children and adolescents show significant adverse alterations in myocardial geometry and function on echocardiography, compared with normal-weight children, according to a report published online Oct. 8 in JACC: Cardiovascular Imaging.

In a prospective, cross-sectional cohort study in Germany, researchers performed two-dimensional echocardiography in 61 obese and 40 nonobese participants aged 8-21 years. All the children were white, free of known disease, and not taking any medications, said Dr. Norman Mangner of the University of Leipzig and Heart Center Leipzig and his associates.

Dr. Norman Mangner
Dr. Norman Mangner

Global ejection fraction was normal in both study groups. However, the obese participants showed thickened LV walls and larger chamber dimensions; as a result, their calculated LV mass and LV mass index were roughly 40% higher than those of nonobese children. Left atrial volume, LA volume index, right atrial area, and right ventricular diameter all were also increased, compared with those of nonobese children. In addition, z scores for LA diameter were above the 95th percentile in a significantly higher percentage of the obese participants (33.3%) than nonobese participants (10%), the investigators said (J. Am. Coll. Cardiol. Img. 2014 Oct. 8 [doi: 10.1016/j.jcmg.2014.08.006]).

Regarding myocardial function, both tissue Doppler-derived peak systolic velocity and deformation in the basoseptal region were reduced in the obese children. Average longitudinal LV strain, strain rate, and displacement – all measures of longitudinal function – were significantly reduced. Average LV circumferential strain was significantly blunted in the obese participants, but the average LV circumferential strain rate and radial function were not significantly different between the two study groups. And diastolic function was decreased in the obese children, as evidenced by their reduced mitral E- to mitral A-wave peak velocity (E/A ratio), reduced mitral annulus tissue Doppler imaging (TDI) peak E-wave velocity, and increased E/E’ ratios.

“It is important to note that [these changes] do not necessarily translate into clinically relevant functional impairment,” Dr. Mangner and his associates said.

A longitudinal study is needed to clarify the clinical significance of these alterations and to explore whether weight loss will reverse them, they added.

This study was supported in part by grants from the German Research Foundation and the Clinical Research Group. One of Dr. Mangner’s associates reported ties to Medtronic, St. Jude Medical, Claret Medical, Boston Scientific, and Edwards; Dr. Mangner and his other associates reported having no financial disclosures.

Obese children and adolescents show significant adverse alterations in myocardial geometry and function on echocardiography, compared with normal-weight children, according to a report published online Oct. 8 in JACC: Cardiovascular Imaging.

In a prospective, cross-sectional cohort study in Germany, researchers performed two-dimensional echocardiography in 61 obese and 40 nonobese participants aged 8-21 years. All the children were white, free of known disease, and not taking any medications, said Dr. Norman Mangner of the University of Leipzig and Heart Center Leipzig and his associates.

Dr. Norman Mangner
Dr. Norman Mangner

Global ejection fraction was normal in both study groups. However, the obese participants showed thickened LV walls and larger chamber dimensions; as a result, their calculated LV mass and LV mass index were roughly 40% higher than those of nonobese children. Left atrial volume, LA volume index, right atrial area, and right ventricular diameter all were also increased, compared with those of nonobese children. In addition, z scores for LA diameter were above the 95th percentile in a significantly higher percentage of the obese participants (33.3%) than nonobese participants (10%), the investigators said (J. Am. Coll. Cardiol. Img. 2014 Oct. 8 [doi: 10.1016/j.jcmg.2014.08.006]).

Regarding myocardial function, both tissue Doppler-derived peak systolic velocity and deformation in the basoseptal region were reduced in the obese children. Average longitudinal LV strain, strain rate, and displacement – all measures of longitudinal function – were significantly reduced. Average LV circumferential strain was significantly blunted in the obese participants, but the average LV circumferential strain rate and radial function were not significantly different between the two study groups. And diastolic function was decreased in the obese children, as evidenced by their reduced mitral E- to mitral A-wave peak velocity (E/A ratio), reduced mitral annulus tissue Doppler imaging (TDI) peak E-wave velocity, and increased E/E’ ratios.

“It is important to note that [these changes] do not necessarily translate into clinically relevant functional impairment,” Dr. Mangner and his associates said.

A longitudinal study is needed to clarify the clinical significance of these alterations and to explore whether weight loss will reverse them, they added.

This study was supported in part by grants from the German Research Foundation and the Clinical Research Group. One of Dr. Mangner’s associates reported ties to Medtronic, St. Jude Medical, Claret Medical, Boston Scientific, and Edwards; Dr. Mangner and his other associates reported having no financial disclosures.

References

References

Publications
Publications
Topics
Article Type
Display Headline
Myocardial geometry, function altered in obese children
Display Headline
Myocardial geometry, function altered in obese children
Legacy Keywords
Obese children, adolescents, myocardial geometry, echocardiography, obesity
Legacy Keywords
Obese children, adolescents, myocardial geometry, echocardiography, obesity
Article Source

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Obese children and adolescents have increased left ventricular mass, decreased LV diastolic function, and other adverse myocardial changes.

Major finding: Obese children and adolescents showed thickened LV walls and larger chamber dimensions, so their calculated LV mass and LV mass index were about 40% higher than those of nonobese children.

Data source: A prospective cross-sectional cohort study involving 61 obese and 40 nonobese participants aged 8-21 years who underwent cardiac echocardiography.

Disclosures: This study was supported in part by grants from the German Research Foundation and the Clinical Research Group. One of Dr. Mangner’s associates reported ties to Medtronic, St. Jude Medical, Claret Medical, Boston Scientific, and Edwards; Dr. Mangner and his other associates reported having no financial disclosures.

CardioMEMS heralds new proactive era in heart failure management

Article Type
Changed
Fri, 01/18/2019 - 14:03
Display Headline
CardioMEMS heralds new proactive era in heart failure management

LAS VEGAS – Clinical roll-out of a recently approved first-in-class implantable pulmonary artery measurement device ushers in a true breakthrough in the management of heart failure patients, experts forecast at the annual meeting of the Heart Failure Society of America.

Noting that in the pivotal phase III CHAMPION trial the use of the wireless implantable CardioMEMS system reduced heart failure–related admissions by 37% with a number needed to treat of just four patients for 1 year in order to avoid one hospitalization, Dr. Phillip B. Adamson declared, “It shifts us from a strategy of crisis management to one of stability management.”

Dr. Philip B. Adamson
Dr. Philip B. Adamson

Earlier this year, the Food and Drug Administration approved the implantable pulmonary artery measurement system for use in patients with New York Heart Association class III heart failure and a heart failure–related hospitalization within the previous 12 months, which defined the study population in the 550-patient randomized, single-blind, pivotal CHAMPION trial. The study included patients with heart failure with preserved ejection fraction (HFpEF) as well as those with reduced ejection fraction (HFrEF). Notably, the intervention was at least as effective in HFpEF as HFrEF.

“We saw roughly a 50% reduction in heart failure hospitalizations with a number needed to treat of two in order to prevent one hospitalization in patients with HFpEF. That’s a pretty profound result in a population of patients for which there’s been no strategy to keep them well and out of hospital,” observed Dr. Adamson, medical director of the Heart Failure Institute at Oklahoma Heart Hospital, Oklahoma City.

The 6-month results of CHAMPION have been published (Lancet 2011;377:658-66). At the heart failure meeting, Dr. Adamson and Dr. William T. Abraham presented updated results of the extended longitudinal analysis of CHAMPION. While heart failure hospitalizations were reduced by 28% during the first 6 months of the study in patients with the device turned on as compared to controls with the device off, the magnitude of benefit grew over time such that for months 6-18 in the randomized phase of the study, the relative risk reduction increased to 45%.

“It looks like we all got better over time at using this pulmonary artery pressure information,” observed Dr. Abraham, professor of internal medicine and physiology and cell biology and director of the division of cardiovascular medicine at Ohio State University, Columbus.

He drew particular attention to the highly significant 16% reduction in the risk of the combined secondary endpoint of death or all-cause hospitalization with the device on over the full duration of the randomized study; that’s an outcome many current standard-of-care pharmacologic and device therapies haven’t been able to achieve.

When former control subjects were crossed over to device-on for 13 months of open-label management, their annualized rate of heart failure hospitalizations dropped by 48%, he continued.

The principle behind this management strategy is that measurable changes in pulmonary artery pressures occur at least several weeks before patients experience symptomatic deterioration and weight gain. And these pressure changes are actionable. By remotely monitoring hemodynamic pressures via the implanted device and promptly adjusting medications in order bring elevated pressures back into target range – for example, to a mean arterial pressure of 10-25 mm Hg – heart failure hospitalizations are avoided.

Dr. William T. Abraham of Columbus OH
Dr. William T. Abraham

“In CHAMPION, even if the patient looked good and felt good, if the pressures were elevated the protocol required that they be lowered to target ranges,” Dr. Abraham explained.

The system works like this: On a daily basis, a patient lies down on a special pillow that interrogates the device for 18 seconds, then transmits the pressure readings to an Internet website. If the readings fall outside target range, an e-mail notification is automatically sent to the patient’s health care provider. Once the office receives the message then a nurse, nurse practitioner, or physician assistant phones the patient and adjusts medications according to a defined protocol based on scripted questions.

On the other hand, if the patient’s pressures are stable, once-weekly review of the readings is generally sufficient. That was the protocol in CHAMPION.

“Patients don’t decompensate overnight,” Dr. Abraham observed. “They decompensate over many days to weeks.”

Audience members had lots of questions about billing. Dr. Adamson explained that remote pulmonary artery pressure monitoring is billable every 31 days, although a physician can’t bill for both pulmonary artery pressure and impedance monitoring.

“You have to have a documented encounter in the patient’s chart in which you reviewed the pressures and what your decision-making process was: either the patient was contacted and the medications increased, or you decided not to change the medications,” he said.

 

 

Also, as of October, Medicare covers the device implantation procedure under a new-technology add-on. Large private insurers are expected to follow suit. A reimbursable procedure is something of a rarity for heart failure specialists, although surgeons and general cardiologists can readily perform the implantation as well, according to Dr. Adamson.

Although for now the device is indicated in patients with NYHA class III heart failure, consideration is now being given to a possible extension of the indication to patients with class II disease as well. That’s largely because of an analysis of Medicare data led by Dr. Adamson that showed that nationally, patients with class II or III heart failure averaged a 24.7% 30-day hospital readmission rate as compared to an 18.5% rate among Medicare participants in CHAMPION.

Asked about patient acceptance of the monitoring program, Dr. Abraham said it was excellent in CHAMPION.

“In the trial, we asked patients to take a measurement daily, and on average, we got measurements on 6 out of 7 days,” he noted.

Sara Paul
Sara Paul

That high adherence rate came as no surprise to Sara Paul, a registered nurse who serves as director of the heart function clinic at Catawba Valley Medical Center in Conover, N.C.

“I think when patients find something that makes them feel better, they’re going to do it. I’m actually a little more concerned about the opposite: the patient who decides to freely partake of salty, fatty foods like pizza and hot dogs, because they know you’re going to be watching them and taking care of them. That’s my concern,” she said.

Under the medication adjustment protocols used in CHAMPION, the initial presumption was that elevated pressures were due to volume overload, so the first step was a simple increase in diuretic therapy. Many patients responded to that, according to Dr. Abraham. If not, the second-line maneuver was to add or increase a nitrate vasodilator on the presumption that the elevated pressures were most likely related to a change in venous capacitance.

Ms. Paul stressed one major caveat regarding pulmonary artery pressure–guided therapy via remote hemodynamic monitoring: The device itself is not directly therapeutic.

“This is not a device that administers treatment. So if you’re going to put this device in a patient, you’d better use the information,” she said.

Dr. Adamson and Dr. Abraham reported receiving speakers honoraria from St. Jude Medical, which markets the CardioMEMS system, as well as serving as consultants to numerous other health care companies. Ms. Paul reported having no financial conflicts.

bjancin@frontlinemedcom.com

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
heart failure 30-day hospitalization wireless pulmonary artery pressure monitoring CardioMems
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event
Related Articles

LAS VEGAS – Clinical roll-out of a recently approved first-in-class implantable pulmonary artery measurement device ushers in a true breakthrough in the management of heart failure patients, experts forecast at the annual meeting of the Heart Failure Society of America.

Noting that in the pivotal phase III CHAMPION trial the use of the wireless implantable CardioMEMS system reduced heart failure–related admissions by 37% with a number needed to treat of just four patients for 1 year in order to avoid one hospitalization, Dr. Phillip B. Adamson declared, “It shifts us from a strategy of crisis management to one of stability management.”

Dr. Philip B. Adamson
Dr. Philip B. Adamson

Earlier this year, the Food and Drug Administration approved the implantable pulmonary artery measurement system for use in patients with New York Heart Association class III heart failure and a heart failure–related hospitalization within the previous 12 months, which defined the study population in the 550-patient randomized, single-blind, pivotal CHAMPION trial. The study included patients with heart failure with preserved ejection fraction (HFpEF) as well as those with reduced ejection fraction (HFrEF). Notably, the intervention was at least as effective in HFpEF as HFrEF.

“We saw roughly a 50% reduction in heart failure hospitalizations with a number needed to treat of two in order to prevent one hospitalization in patients with HFpEF. That’s a pretty profound result in a population of patients for which there’s been no strategy to keep them well and out of hospital,” observed Dr. Adamson, medical director of the Heart Failure Institute at Oklahoma Heart Hospital, Oklahoma City.

The 6-month results of CHAMPION have been published (Lancet 2011;377:658-66). At the heart failure meeting, Dr. Adamson and Dr. William T. Abraham presented updated results of the extended longitudinal analysis of CHAMPION. While heart failure hospitalizations were reduced by 28% during the first 6 months of the study in patients with the device turned on as compared to controls with the device off, the magnitude of benefit grew over time such that for months 6-18 in the randomized phase of the study, the relative risk reduction increased to 45%.

“It looks like we all got better over time at using this pulmonary artery pressure information,” observed Dr. Abraham, professor of internal medicine and physiology and cell biology and director of the division of cardiovascular medicine at Ohio State University, Columbus.

He drew particular attention to the highly significant 16% reduction in the risk of the combined secondary endpoint of death or all-cause hospitalization with the device on over the full duration of the randomized study; that’s an outcome many current standard-of-care pharmacologic and device therapies haven’t been able to achieve.

When former control subjects were crossed over to device-on for 13 months of open-label management, their annualized rate of heart failure hospitalizations dropped by 48%, he continued.

The principle behind this management strategy is that measurable changes in pulmonary artery pressures occur at least several weeks before patients experience symptomatic deterioration and weight gain. And these pressure changes are actionable. By remotely monitoring hemodynamic pressures via the implanted device and promptly adjusting medications in order bring elevated pressures back into target range – for example, to a mean arterial pressure of 10-25 mm Hg – heart failure hospitalizations are avoided.

Dr. William T. Abraham of Columbus OH
Dr. William T. Abraham

“In CHAMPION, even if the patient looked good and felt good, if the pressures were elevated the protocol required that they be lowered to target ranges,” Dr. Abraham explained.

The system works like this: On a daily basis, a patient lies down on a special pillow that interrogates the device for 18 seconds, then transmits the pressure readings to an Internet website. If the readings fall outside target range, an e-mail notification is automatically sent to the patient’s health care provider. Once the office receives the message then a nurse, nurse practitioner, or physician assistant phones the patient and adjusts medications according to a defined protocol based on scripted questions.

On the other hand, if the patient’s pressures are stable, once-weekly review of the readings is generally sufficient. That was the protocol in CHAMPION.

“Patients don’t decompensate overnight,” Dr. Abraham observed. “They decompensate over many days to weeks.”

Audience members had lots of questions about billing. Dr. Adamson explained that remote pulmonary artery pressure monitoring is billable every 31 days, although a physician can’t bill for both pulmonary artery pressure and impedance monitoring.

“You have to have a documented encounter in the patient’s chart in which you reviewed the pressures and what your decision-making process was: either the patient was contacted and the medications increased, or you decided not to change the medications,” he said.

 

 

Also, as of October, Medicare covers the device implantation procedure under a new-technology add-on. Large private insurers are expected to follow suit. A reimbursable procedure is something of a rarity for heart failure specialists, although surgeons and general cardiologists can readily perform the implantation as well, according to Dr. Adamson.

Although for now the device is indicated in patients with NYHA class III heart failure, consideration is now being given to a possible extension of the indication to patients with class II disease as well. That’s largely because of an analysis of Medicare data led by Dr. Adamson that showed that nationally, patients with class II or III heart failure averaged a 24.7% 30-day hospital readmission rate as compared to an 18.5% rate among Medicare participants in CHAMPION.

Asked about patient acceptance of the monitoring program, Dr. Abraham said it was excellent in CHAMPION.

“In the trial, we asked patients to take a measurement daily, and on average, we got measurements on 6 out of 7 days,” he noted.

Sara Paul
Sara Paul

That high adherence rate came as no surprise to Sara Paul, a registered nurse who serves as director of the heart function clinic at Catawba Valley Medical Center in Conover, N.C.

“I think when patients find something that makes them feel better, they’re going to do it. I’m actually a little more concerned about the opposite: the patient who decides to freely partake of salty, fatty foods like pizza and hot dogs, because they know you’re going to be watching them and taking care of them. That’s my concern,” she said.

Under the medication adjustment protocols used in CHAMPION, the initial presumption was that elevated pressures were due to volume overload, so the first step was a simple increase in diuretic therapy. Many patients responded to that, according to Dr. Abraham. If not, the second-line maneuver was to add or increase a nitrate vasodilator on the presumption that the elevated pressures were most likely related to a change in venous capacitance.

Ms. Paul stressed one major caveat regarding pulmonary artery pressure–guided therapy via remote hemodynamic monitoring: The device itself is not directly therapeutic.

“This is not a device that administers treatment. So if you’re going to put this device in a patient, you’d better use the information,” she said.

Dr. Adamson and Dr. Abraham reported receiving speakers honoraria from St. Jude Medical, which markets the CardioMEMS system, as well as serving as consultants to numerous other health care companies. Ms. Paul reported having no financial conflicts.

bjancin@frontlinemedcom.com

LAS VEGAS – Clinical roll-out of a recently approved first-in-class implantable pulmonary artery measurement device ushers in a true breakthrough in the management of heart failure patients, experts forecast at the annual meeting of the Heart Failure Society of America.

Noting that in the pivotal phase III CHAMPION trial the use of the wireless implantable CardioMEMS system reduced heart failure–related admissions by 37% with a number needed to treat of just four patients for 1 year in order to avoid one hospitalization, Dr. Phillip B. Adamson declared, “It shifts us from a strategy of crisis management to one of stability management.”

Dr. Philip B. Adamson
Dr. Philip B. Adamson

Earlier this year, the Food and Drug Administration approved the implantable pulmonary artery measurement system for use in patients with New York Heart Association class III heart failure and a heart failure–related hospitalization within the previous 12 months, which defined the study population in the 550-patient randomized, single-blind, pivotal CHAMPION trial. The study included patients with heart failure with preserved ejection fraction (HFpEF) as well as those with reduced ejection fraction (HFrEF). Notably, the intervention was at least as effective in HFpEF as HFrEF.

“We saw roughly a 50% reduction in heart failure hospitalizations with a number needed to treat of two in order to prevent one hospitalization in patients with HFpEF. That’s a pretty profound result in a population of patients for which there’s been no strategy to keep them well and out of hospital,” observed Dr. Adamson, medical director of the Heart Failure Institute at Oklahoma Heart Hospital, Oklahoma City.

The 6-month results of CHAMPION have been published (Lancet 2011;377:658-66). At the heart failure meeting, Dr. Adamson and Dr. William T. Abraham presented updated results of the extended longitudinal analysis of CHAMPION. While heart failure hospitalizations were reduced by 28% during the first 6 months of the study in patients with the device turned on as compared to controls with the device off, the magnitude of benefit grew over time such that for months 6-18 in the randomized phase of the study, the relative risk reduction increased to 45%.

“It looks like we all got better over time at using this pulmonary artery pressure information,” observed Dr. Abraham, professor of internal medicine and physiology and cell biology and director of the division of cardiovascular medicine at Ohio State University, Columbus.

He drew particular attention to the highly significant 16% reduction in the risk of the combined secondary endpoint of death or all-cause hospitalization with the device on over the full duration of the randomized study; that’s an outcome many current standard-of-care pharmacologic and device therapies haven’t been able to achieve.

When former control subjects were crossed over to device-on for 13 months of open-label management, their annualized rate of heart failure hospitalizations dropped by 48%, he continued.

The principle behind this management strategy is that measurable changes in pulmonary artery pressures occur at least several weeks before patients experience symptomatic deterioration and weight gain. And these pressure changes are actionable. By remotely monitoring hemodynamic pressures via the implanted device and promptly adjusting medications in order bring elevated pressures back into target range – for example, to a mean arterial pressure of 10-25 mm Hg – heart failure hospitalizations are avoided.

Dr. William T. Abraham of Columbus OH
Dr. William T. Abraham

“In CHAMPION, even if the patient looked good and felt good, if the pressures were elevated the protocol required that they be lowered to target ranges,” Dr. Abraham explained.

The system works like this: On a daily basis, a patient lies down on a special pillow that interrogates the device for 18 seconds, then transmits the pressure readings to an Internet website. If the readings fall outside target range, an e-mail notification is automatically sent to the patient’s health care provider. Once the office receives the message then a nurse, nurse practitioner, or physician assistant phones the patient and adjusts medications according to a defined protocol based on scripted questions.

On the other hand, if the patient’s pressures are stable, once-weekly review of the readings is generally sufficient. That was the protocol in CHAMPION.

“Patients don’t decompensate overnight,” Dr. Abraham observed. “They decompensate over many days to weeks.”

Audience members had lots of questions about billing. Dr. Adamson explained that remote pulmonary artery pressure monitoring is billable every 31 days, although a physician can’t bill for both pulmonary artery pressure and impedance monitoring.

“You have to have a documented encounter in the patient’s chart in which you reviewed the pressures and what your decision-making process was: either the patient was contacted and the medications increased, or you decided not to change the medications,” he said.

 

 

Also, as of October, Medicare covers the device implantation procedure under a new-technology add-on. Large private insurers are expected to follow suit. A reimbursable procedure is something of a rarity for heart failure specialists, although surgeons and general cardiologists can readily perform the implantation as well, according to Dr. Adamson.

Although for now the device is indicated in patients with NYHA class III heart failure, consideration is now being given to a possible extension of the indication to patients with class II disease as well. That’s largely because of an analysis of Medicare data led by Dr. Adamson that showed that nationally, patients with class II or III heart failure averaged a 24.7% 30-day hospital readmission rate as compared to an 18.5% rate among Medicare participants in CHAMPION.

Asked about patient acceptance of the monitoring program, Dr. Abraham said it was excellent in CHAMPION.

“In the trial, we asked patients to take a measurement daily, and on average, we got measurements on 6 out of 7 days,” he noted.

Sara Paul
Sara Paul

That high adherence rate came as no surprise to Sara Paul, a registered nurse who serves as director of the heart function clinic at Catawba Valley Medical Center in Conover, N.C.

“I think when patients find something that makes them feel better, they’re going to do it. I’m actually a little more concerned about the opposite: the patient who decides to freely partake of salty, fatty foods like pizza and hot dogs, because they know you’re going to be watching them and taking care of them. That’s my concern,” she said.

Under the medication adjustment protocols used in CHAMPION, the initial presumption was that elevated pressures were due to volume overload, so the first step was a simple increase in diuretic therapy. Many patients responded to that, according to Dr. Abraham. If not, the second-line maneuver was to add or increase a nitrate vasodilator on the presumption that the elevated pressures were most likely related to a change in venous capacitance.

Ms. Paul stressed one major caveat regarding pulmonary artery pressure–guided therapy via remote hemodynamic monitoring: The device itself is not directly therapeutic.

“This is not a device that administers treatment. So if you’re going to put this device in a patient, you’d better use the information,” she said.

Dr. Adamson and Dr. Abraham reported receiving speakers honoraria from St. Jude Medical, which markets the CardioMEMS system, as well as serving as consultants to numerous other health care companies. Ms. Paul reported having no financial conflicts.

bjancin@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
CardioMEMS heralds new proactive era in heart failure management
Display Headline
CardioMEMS heralds new proactive era in heart failure management
Legacy Keywords
heart failure 30-day hospitalization wireless pulmonary artery pressure monitoring CardioMems
Legacy Keywords
heart failure 30-day hospitalization wireless pulmonary artery pressure monitoring CardioMems
Article Source

EXPERT ANALYSIS FROM THE HFSA ANNUAL SCIENTIFIC MEETING

PURLs Copyright

Inside the Article

Should LCZ696 receive a level I indication?

Article Type
Changed
Fri, 01/18/2019 - 14:03
Display Headline
Should LCZ696 receive a level I indication?

LAS VEGAS – Additional findings from the landmark PARADIGM-HF trial presented at the annual meeting of the Heart Failure Society of America provided what many observers deemed a persuasive case for the novel angiotensin receptor neprilysin inhibitor known for now as LCZ696 as deserving of a level I indication in the next update of the major heart failure management guidelines.

Dr. Milton Packer
Dr. Milton Packer

At a special session added late to the meeting program in the wake of the spectacularly positive top-line results of PARADIGM-HF presented just a few weeks earlier at the European Society of Cardiology meeting in Barcelona, an international panel of heart failure heavyweights tackled questions about the study’s implications, including whether the results need replication in a second randomized controlled trial before LCZ696 can win regulatory approval. And once approved, should guidelines committees give it a level I, must-use indication? How applicable are the PARADIGM-HF results to the broader population of heart failure patients, and in particular black patients and older individuals with class III/IV heart failure? And what about patients with heart failure with preserved ejection fraction (HFpEF) ?

In other words, does PARADIGM-HF, with more than 8,400 randomized subjects, represent a true paradigm shift in heart failure management?

For coprincipal investigator Dr. Milton Packer, the answer is a resounding yes.

“For the past 25 years, the magnitude of the effect of ACE inhibitors on cardiovascular mortality – about an 18% reduction – has created an ethical mandate for their use in all patients with chronic heart failure who could tolerate treatment with these drugs. The finding that LCZ696 has a 20% greater effect on cardiovascular mortality than ACE inhibitors strongly supports the conclusion that LCZ696 should replace the current use of ACE inhibitors and angiotensin receptor blockers in the management of chronic heart failure,” said Dr. Packer, professor and chair of the department of clinical sciences at University of Texas Southwestern Medical Center, Dallas.

Dr. John McMurray
Naseem S. Miller/Frontline Medical News
Dr. John McMurray

His coprincipal investigator, Dr. John J.V. McMurray, cited the statistical strength of the PARADIGM-HF results for the primary composite outcome of cardiovascular death or heart failure hospitalization, which had an extraordinary P value of .0000004, in making the case that the trial findings are sufficient to win regulatory approval without a confirmatory study.

He noted that the regulatory standard in the United States and Europe is that a positive clinical trial having a P value of less than .05 requires replication in a second study that also yields outcomes with a P value of less than .05.

“If, however, you have a large single trial, you can win approval by meeting a standard of P less than .00125. The strength of the result of PARADIGM-HF, with a P of .0000004, is equivalent to between four and five single trials replicated at P less than .05. And for the endpoint of cardiovascular mortality, where the PARADIGM-HF result was significant at a P of .00008, that’s equivalent to between two and three trials replicated at P less than .05. So in my view PARADIGM-HF easily meets the criteria for a level IA indication,” said Dr. McMurray, professor of cardiology at the University of Glasgow.

He presented for the first time a new analysis with a major wow factor. This was an imputed placebo analysis providing the answer to a question many cardiologists have asked him since the presentation of the top-line PARADIGM-HF results in Barcelona: namely, how would LCZ696 have stacked up in a placebo-controlled trial?

Such a study wouldn’t be ethical now, of course, but it’s possible to make inferences by comparing LCZ696’s superiority to enalapril at 10 mg b.i.d. in PARADIGM-HF to enalapril’s performance at the same dose relative to placebo in the earlier 2,569-patient SOLVD-Treatment trial, which featured the same composite primary endpoint (N. Engl. J. Med. 1991;325:293-302).

In SOLVD-Treatment, enalapril resulted in a 28% relative risk reduction in the composite endpoint, compared with placebo. Through indirect comparison, LCZ696 would have an imputed 43% relative risk reduction, compared with placebo. For the endpoint of cardiovascular mortality, enalapril showed a 17% risk reduction relative to placebo; when the PARADIGM-HF results are factored in, this translates to an inferred 34% relative risk reduction for LCZ696 versus placebo.

Similarly, in the CHARM-Alternative trial (Lancet 2003;362:772-6), which featured 2,028 patients on more contemporary guideline–recommended background therapy than in SOLVD-Treatment, patients on the angiotensin receptor blocker candesartan showed a 23% relative risk reduction in the composite endpoint, compared with placebo, along with a 15% reduction in cardiovascular mortality. In the imputed placebo analysis, this translated to relative risk reductions of 49% and 34%, respectively, for LCZ696 versus placebo.

 

 

“We see a doubling in the reduction in cardiovascular mortality with this new therapy over and above that obtained with an ACE inhibitor or ARB [angiotensin receptor blocker],” Dr. McMurray emphasized.

Dr. Marvin A. Konstam
Dr. Marvin A. Konstam

Panelist Dr. Lynne W. Stevenson wasn’t convinced.

“I don’t believe it is time to replace ACE inhibitors and ARBs. I don’t think LCZ696 is ready for a level I [treatment should be performed] indication; that is a higher bar. ... I think we could see a level IIa [treatment is reasonable to perform] indication based on the strong results that we’ve seen,” said Dr. Stevenson, director of the heart failure and cardiomyopathy program at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

She estimated that fewer than 10% of U.S. heart failure patients fit the description of PARADIGM-HF participants, with mild to moderate heart failure with reduced ejection fraction. Importantly, the run-in process employed in the study ensured that only patients with a demonstrated ability to tolerate enalapril in therapeutic doses were enrolled. And even in that filtered population, there was a substantial dropout rate in the LCZ696 arm due to hypotension during follow-up.

“I certainly don’t think we have any information about patients newly diagnosed with heart failure. I don’t think if you put new heart failure patients on LCZ696, they’d necessarily be able to stand up, and if they could stand up I’m not sure we could get them on the appropriate dose of beta blockers,” Dr. Stevenson added.

Noting that only 5% of PARADIGM-HF participants were black, she said that “clearly this is something we will need to watch as we get more experience with this drug, but there was no signal of concern.”

Dr. Marvin A. Konstam, professor of medicine at Tufts University, Boston, shared one of Dr. Stevenson’s concerns: “How do we know what will happen with ACE inhibitor virgins in the real world where you don’t get a run-in period?”

Panelist Dr. John G.F. Cleland said, “I don’t want to second-guess the guideline committees, but surely this must be a IA [data derived from multiple clinical trials or meta-analyses] indication. What intrigues me is what will the indication for ACE inhibitors look like in future guidelines? Is it also going to be IA in the same group of patients? That’s something the guidelines committees are going to have to sort out.”

“A lot of these questions and people’s concerns will either be increased or reduced once we start to get the medicine into clinical practice. What I find quite distressing is that we might be sitting here at this time next year and still not be in a position to prescribe this agent because it may still be going through the regulatory process,” said Dr. Cleland, professor of cardiology at the University of Hull (England).

bjancin@frontlinemedcom.com

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
LCZ696, ARNI, heart failure, PARADIGM-HF,
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

LAS VEGAS – Additional findings from the landmark PARADIGM-HF trial presented at the annual meeting of the Heart Failure Society of America provided what many observers deemed a persuasive case for the novel angiotensin receptor neprilysin inhibitor known for now as LCZ696 as deserving of a level I indication in the next update of the major heart failure management guidelines.

Dr. Milton Packer
Dr. Milton Packer

At a special session added late to the meeting program in the wake of the spectacularly positive top-line results of PARADIGM-HF presented just a few weeks earlier at the European Society of Cardiology meeting in Barcelona, an international panel of heart failure heavyweights tackled questions about the study’s implications, including whether the results need replication in a second randomized controlled trial before LCZ696 can win regulatory approval. And once approved, should guidelines committees give it a level I, must-use indication? How applicable are the PARADIGM-HF results to the broader population of heart failure patients, and in particular black patients and older individuals with class III/IV heart failure? And what about patients with heart failure with preserved ejection fraction (HFpEF) ?

In other words, does PARADIGM-HF, with more than 8,400 randomized subjects, represent a true paradigm shift in heart failure management?

For coprincipal investigator Dr. Milton Packer, the answer is a resounding yes.

“For the past 25 years, the magnitude of the effect of ACE inhibitors on cardiovascular mortality – about an 18% reduction – has created an ethical mandate for their use in all patients with chronic heart failure who could tolerate treatment with these drugs. The finding that LCZ696 has a 20% greater effect on cardiovascular mortality than ACE inhibitors strongly supports the conclusion that LCZ696 should replace the current use of ACE inhibitors and angiotensin receptor blockers in the management of chronic heart failure,” said Dr. Packer, professor and chair of the department of clinical sciences at University of Texas Southwestern Medical Center, Dallas.

Dr. John McMurray
Naseem S. Miller/Frontline Medical News
Dr. John McMurray

His coprincipal investigator, Dr. John J.V. McMurray, cited the statistical strength of the PARADIGM-HF results for the primary composite outcome of cardiovascular death or heart failure hospitalization, which had an extraordinary P value of .0000004, in making the case that the trial findings are sufficient to win regulatory approval without a confirmatory study.

He noted that the regulatory standard in the United States and Europe is that a positive clinical trial having a P value of less than .05 requires replication in a second study that also yields outcomes with a P value of less than .05.

“If, however, you have a large single trial, you can win approval by meeting a standard of P less than .00125. The strength of the result of PARADIGM-HF, with a P of .0000004, is equivalent to between four and five single trials replicated at P less than .05. And for the endpoint of cardiovascular mortality, where the PARADIGM-HF result was significant at a P of .00008, that’s equivalent to between two and three trials replicated at P less than .05. So in my view PARADIGM-HF easily meets the criteria for a level IA indication,” said Dr. McMurray, professor of cardiology at the University of Glasgow.

He presented for the first time a new analysis with a major wow factor. This was an imputed placebo analysis providing the answer to a question many cardiologists have asked him since the presentation of the top-line PARADIGM-HF results in Barcelona: namely, how would LCZ696 have stacked up in a placebo-controlled trial?

Such a study wouldn’t be ethical now, of course, but it’s possible to make inferences by comparing LCZ696’s superiority to enalapril at 10 mg b.i.d. in PARADIGM-HF to enalapril’s performance at the same dose relative to placebo in the earlier 2,569-patient SOLVD-Treatment trial, which featured the same composite primary endpoint (N. Engl. J. Med. 1991;325:293-302).

In SOLVD-Treatment, enalapril resulted in a 28% relative risk reduction in the composite endpoint, compared with placebo. Through indirect comparison, LCZ696 would have an imputed 43% relative risk reduction, compared with placebo. For the endpoint of cardiovascular mortality, enalapril showed a 17% risk reduction relative to placebo; when the PARADIGM-HF results are factored in, this translates to an inferred 34% relative risk reduction for LCZ696 versus placebo.

Similarly, in the CHARM-Alternative trial (Lancet 2003;362:772-6), which featured 2,028 patients on more contemporary guideline–recommended background therapy than in SOLVD-Treatment, patients on the angiotensin receptor blocker candesartan showed a 23% relative risk reduction in the composite endpoint, compared with placebo, along with a 15% reduction in cardiovascular mortality. In the imputed placebo analysis, this translated to relative risk reductions of 49% and 34%, respectively, for LCZ696 versus placebo.

 

 

“We see a doubling in the reduction in cardiovascular mortality with this new therapy over and above that obtained with an ACE inhibitor or ARB [angiotensin receptor blocker],” Dr. McMurray emphasized.

Dr. Marvin A. Konstam
Dr. Marvin A. Konstam

Panelist Dr. Lynne W. Stevenson wasn’t convinced.

“I don’t believe it is time to replace ACE inhibitors and ARBs. I don’t think LCZ696 is ready for a level I [treatment should be performed] indication; that is a higher bar. ... I think we could see a level IIa [treatment is reasonable to perform] indication based on the strong results that we’ve seen,” said Dr. Stevenson, director of the heart failure and cardiomyopathy program at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

She estimated that fewer than 10% of U.S. heart failure patients fit the description of PARADIGM-HF participants, with mild to moderate heart failure with reduced ejection fraction. Importantly, the run-in process employed in the study ensured that only patients with a demonstrated ability to tolerate enalapril in therapeutic doses were enrolled. And even in that filtered population, there was a substantial dropout rate in the LCZ696 arm due to hypotension during follow-up.

“I certainly don’t think we have any information about patients newly diagnosed with heart failure. I don’t think if you put new heart failure patients on LCZ696, they’d necessarily be able to stand up, and if they could stand up I’m not sure we could get them on the appropriate dose of beta blockers,” Dr. Stevenson added.

Noting that only 5% of PARADIGM-HF participants were black, she said that “clearly this is something we will need to watch as we get more experience with this drug, but there was no signal of concern.”

Dr. Marvin A. Konstam, professor of medicine at Tufts University, Boston, shared one of Dr. Stevenson’s concerns: “How do we know what will happen with ACE inhibitor virgins in the real world where you don’t get a run-in period?”

Panelist Dr. John G.F. Cleland said, “I don’t want to second-guess the guideline committees, but surely this must be a IA [data derived from multiple clinical trials or meta-analyses] indication. What intrigues me is what will the indication for ACE inhibitors look like in future guidelines? Is it also going to be IA in the same group of patients? That’s something the guidelines committees are going to have to sort out.”

“A lot of these questions and people’s concerns will either be increased or reduced once we start to get the medicine into clinical practice. What I find quite distressing is that we might be sitting here at this time next year and still not be in a position to prescribe this agent because it may still be going through the regulatory process,” said Dr. Cleland, professor of cardiology at the University of Hull (England).

bjancin@frontlinemedcom.com

LAS VEGAS – Additional findings from the landmark PARADIGM-HF trial presented at the annual meeting of the Heart Failure Society of America provided what many observers deemed a persuasive case for the novel angiotensin receptor neprilysin inhibitor known for now as LCZ696 as deserving of a level I indication in the next update of the major heart failure management guidelines.

Dr. Milton Packer
Dr. Milton Packer

At a special session added late to the meeting program in the wake of the spectacularly positive top-line results of PARADIGM-HF presented just a few weeks earlier at the European Society of Cardiology meeting in Barcelona, an international panel of heart failure heavyweights tackled questions about the study’s implications, including whether the results need replication in a second randomized controlled trial before LCZ696 can win regulatory approval. And once approved, should guidelines committees give it a level I, must-use indication? How applicable are the PARADIGM-HF results to the broader population of heart failure patients, and in particular black patients and older individuals with class III/IV heart failure? And what about patients with heart failure with preserved ejection fraction (HFpEF) ?

In other words, does PARADIGM-HF, with more than 8,400 randomized subjects, represent a true paradigm shift in heart failure management?

For coprincipal investigator Dr. Milton Packer, the answer is a resounding yes.

“For the past 25 years, the magnitude of the effect of ACE inhibitors on cardiovascular mortality – about an 18% reduction – has created an ethical mandate for their use in all patients with chronic heart failure who could tolerate treatment with these drugs. The finding that LCZ696 has a 20% greater effect on cardiovascular mortality than ACE inhibitors strongly supports the conclusion that LCZ696 should replace the current use of ACE inhibitors and angiotensin receptor blockers in the management of chronic heart failure,” said Dr. Packer, professor and chair of the department of clinical sciences at University of Texas Southwestern Medical Center, Dallas.

Dr. John McMurray
Naseem S. Miller/Frontline Medical News
Dr. John McMurray

His coprincipal investigator, Dr. John J.V. McMurray, cited the statistical strength of the PARADIGM-HF results for the primary composite outcome of cardiovascular death or heart failure hospitalization, which had an extraordinary P value of .0000004, in making the case that the trial findings are sufficient to win regulatory approval without a confirmatory study.

He noted that the regulatory standard in the United States and Europe is that a positive clinical trial having a P value of less than .05 requires replication in a second study that also yields outcomes with a P value of less than .05.

“If, however, you have a large single trial, you can win approval by meeting a standard of P less than .00125. The strength of the result of PARADIGM-HF, with a P of .0000004, is equivalent to between four and five single trials replicated at P less than .05. And for the endpoint of cardiovascular mortality, where the PARADIGM-HF result was significant at a P of .00008, that’s equivalent to between two and three trials replicated at P less than .05. So in my view PARADIGM-HF easily meets the criteria for a level IA indication,” said Dr. McMurray, professor of cardiology at the University of Glasgow.

He presented for the first time a new analysis with a major wow factor. This was an imputed placebo analysis providing the answer to a question many cardiologists have asked him since the presentation of the top-line PARADIGM-HF results in Barcelona: namely, how would LCZ696 have stacked up in a placebo-controlled trial?

Such a study wouldn’t be ethical now, of course, but it’s possible to make inferences by comparing LCZ696’s superiority to enalapril at 10 mg b.i.d. in PARADIGM-HF to enalapril’s performance at the same dose relative to placebo in the earlier 2,569-patient SOLVD-Treatment trial, which featured the same composite primary endpoint (N. Engl. J. Med. 1991;325:293-302).

In SOLVD-Treatment, enalapril resulted in a 28% relative risk reduction in the composite endpoint, compared with placebo. Through indirect comparison, LCZ696 would have an imputed 43% relative risk reduction, compared with placebo. For the endpoint of cardiovascular mortality, enalapril showed a 17% risk reduction relative to placebo; when the PARADIGM-HF results are factored in, this translates to an inferred 34% relative risk reduction for LCZ696 versus placebo.

Similarly, in the CHARM-Alternative trial (Lancet 2003;362:772-6), which featured 2,028 patients on more contemporary guideline–recommended background therapy than in SOLVD-Treatment, patients on the angiotensin receptor blocker candesartan showed a 23% relative risk reduction in the composite endpoint, compared with placebo, along with a 15% reduction in cardiovascular mortality. In the imputed placebo analysis, this translated to relative risk reductions of 49% and 34%, respectively, for LCZ696 versus placebo.

 

 

“We see a doubling in the reduction in cardiovascular mortality with this new therapy over and above that obtained with an ACE inhibitor or ARB [angiotensin receptor blocker],” Dr. McMurray emphasized.

Dr. Marvin A. Konstam
Dr. Marvin A. Konstam

Panelist Dr. Lynne W. Stevenson wasn’t convinced.

“I don’t believe it is time to replace ACE inhibitors and ARBs. I don’t think LCZ696 is ready for a level I [treatment should be performed] indication; that is a higher bar. ... I think we could see a level IIa [treatment is reasonable to perform] indication based on the strong results that we’ve seen,” said Dr. Stevenson, director of the heart failure and cardiomyopathy program at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

She estimated that fewer than 10% of U.S. heart failure patients fit the description of PARADIGM-HF participants, with mild to moderate heart failure with reduced ejection fraction. Importantly, the run-in process employed in the study ensured that only patients with a demonstrated ability to tolerate enalapril in therapeutic doses were enrolled. And even in that filtered population, there was a substantial dropout rate in the LCZ696 arm due to hypotension during follow-up.

“I certainly don’t think we have any information about patients newly diagnosed with heart failure. I don’t think if you put new heart failure patients on LCZ696, they’d necessarily be able to stand up, and if they could stand up I’m not sure we could get them on the appropriate dose of beta blockers,” Dr. Stevenson added.

Noting that only 5% of PARADIGM-HF participants were black, she said that “clearly this is something we will need to watch as we get more experience with this drug, but there was no signal of concern.”

Dr. Marvin A. Konstam, professor of medicine at Tufts University, Boston, shared one of Dr. Stevenson’s concerns: “How do we know what will happen with ACE inhibitor virgins in the real world where you don’t get a run-in period?”

Panelist Dr. John G.F. Cleland said, “I don’t want to second-guess the guideline committees, but surely this must be a IA [data derived from multiple clinical trials or meta-analyses] indication. What intrigues me is what will the indication for ACE inhibitors look like in future guidelines? Is it also going to be IA in the same group of patients? That’s something the guidelines committees are going to have to sort out.”

“A lot of these questions and people’s concerns will either be increased or reduced once we start to get the medicine into clinical practice. What I find quite distressing is that we might be sitting here at this time next year and still not be in a position to prescribe this agent because it may still be going through the regulatory process,” said Dr. Cleland, professor of cardiology at the University of Hull (England).

bjancin@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
Should LCZ696 receive a level I indication?
Display Headline
Should LCZ696 receive a level I indication?
Legacy Keywords
LCZ696, ARNI, heart failure, PARADIGM-HF,
Legacy Keywords
LCZ696, ARNI, heart failure, PARADIGM-HF,
Sections
Article Source

EXPERT OPINION FROM THE HFSA ANNUAL SCIENTIFIC MEETING

PURLs Copyright

Inside the Article

What about LCZ696 for heart failure with preserved ejection fraction?

Article Type
Changed
Fri, 01/18/2019 - 14:03
Display Headline
What about LCZ696 for heart failure with preserved ejection fraction?

LAS VEGAS – Having scored a spectacular success with its investigational agent LCZ696 for the treatment of heart failure with reduced ejection fraction in the landmark PARADIGM-HF trial, Novartis has placed a large bet that it can do the same in patients with heart failure with preserved ejection fraction in the ongoing PARAGON trial.

The phase III study, which began this summer, will enroll roughly 4,300 patients with symptomatic heart failure with preserved ejection fraction (HFpEF) in 37 countries. They are being randomized to the novel, first-in-class angiotensin receptor neprilysin inhibitor (ARNI) known for now as LCZ696 at 200 mg b.i.d. or valsartan at 160 mg b.i.d., PARAGON principal investigator Dr. Scott D. Solomon explained at the annual meeting of the Heart Failure Society of America.

The study is a bit of a gamble because, to date, there is no effective treatment for HFpEF, which accounts for at least half of all cases of heart failure. Four prior major clinical trials testing various candidate therapies have all gone down in flames, failing to achieve their primary endpoints, but there are multiple reasons to believe PARAGON will be different, according to Dr. Solomon, professor of medicine at Harvard Medical School, Boston.

For one thing, previous major trials enrolled some participants without clear evidence that they even had HFpEF. Not so in PARAGON, which requires subjects to have symptomatic heart failure, an ejection fraction of 45% or more, and evidence of structural heart disease along with either a hospitalization for heart failure within the previous 9 months or elevated natriuretic peptides.

Also, unlike the prior disappointing studies involving other agents, PARAGON is supported by positive findings in a phase II proof-of-concept study. In the phase II, double-blind PARAMOUNT trial, also led by Dr. Solomon, 301 patients with HFpEF were randomized to LCZ696 or valsartan for 36 weeks. The primary study endpoint was change in N-terminal of the prohormone brain natriuretic hormone (NT-proBNP), a biomarker of left ventricular wall stress, through 12 weeks. The result was positive, with a 23% greater reduction in elevated baseline levels in the LCZ696 group, compared with those on valsartan (Lancet 2012;380:1387-95).

By 36 weeks, the ARNI-treated patients also showed a significant reduction in left atrial volume as well as improvement in New York Heart Association functional class, the cardiologist added.

PARAGON features a novel primary endpoint: a composite of cardiovascular death and total hospitalizations for heart failure, rather than time to the first hospitalization, as used in previous trials. “Total hospitalizations for heart failure better captures the full burden of the disease,” Dr. Solomon explained.

Results of PARAGON are expected in 2019.

Dr. Solomon has received research grants and honoraria from Novartis, which is funding the PARAGON trial.

bjancin@frontlinemedcom.com

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
LCA696 ARNI PARAGON HFpEF
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

LAS VEGAS – Having scored a spectacular success with its investigational agent LCZ696 for the treatment of heart failure with reduced ejection fraction in the landmark PARADIGM-HF trial, Novartis has placed a large bet that it can do the same in patients with heart failure with preserved ejection fraction in the ongoing PARAGON trial.

The phase III study, which began this summer, will enroll roughly 4,300 patients with symptomatic heart failure with preserved ejection fraction (HFpEF) in 37 countries. They are being randomized to the novel, first-in-class angiotensin receptor neprilysin inhibitor (ARNI) known for now as LCZ696 at 200 mg b.i.d. or valsartan at 160 mg b.i.d., PARAGON principal investigator Dr. Scott D. Solomon explained at the annual meeting of the Heart Failure Society of America.

The study is a bit of a gamble because, to date, there is no effective treatment for HFpEF, which accounts for at least half of all cases of heart failure. Four prior major clinical trials testing various candidate therapies have all gone down in flames, failing to achieve their primary endpoints, but there are multiple reasons to believe PARAGON will be different, according to Dr. Solomon, professor of medicine at Harvard Medical School, Boston.

For one thing, previous major trials enrolled some participants without clear evidence that they even had HFpEF. Not so in PARAGON, which requires subjects to have symptomatic heart failure, an ejection fraction of 45% or more, and evidence of structural heart disease along with either a hospitalization for heart failure within the previous 9 months or elevated natriuretic peptides.

Also, unlike the prior disappointing studies involving other agents, PARAGON is supported by positive findings in a phase II proof-of-concept study. In the phase II, double-blind PARAMOUNT trial, also led by Dr. Solomon, 301 patients with HFpEF were randomized to LCZ696 or valsartan for 36 weeks. The primary study endpoint was change in N-terminal of the prohormone brain natriuretic hormone (NT-proBNP), a biomarker of left ventricular wall stress, through 12 weeks. The result was positive, with a 23% greater reduction in elevated baseline levels in the LCZ696 group, compared with those on valsartan (Lancet 2012;380:1387-95).

By 36 weeks, the ARNI-treated patients also showed a significant reduction in left atrial volume as well as improvement in New York Heart Association functional class, the cardiologist added.

PARAGON features a novel primary endpoint: a composite of cardiovascular death and total hospitalizations for heart failure, rather than time to the first hospitalization, as used in previous trials. “Total hospitalizations for heart failure better captures the full burden of the disease,” Dr. Solomon explained.

Results of PARAGON are expected in 2019.

Dr. Solomon has received research grants and honoraria from Novartis, which is funding the PARAGON trial.

bjancin@frontlinemedcom.com

LAS VEGAS – Having scored a spectacular success with its investigational agent LCZ696 for the treatment of heart failure with reduced ejection fraction in the landmark PARADIGM-HF trial, Novartis has placed a large bet that it can do the same in patients with heart failure with preserved ejection fraction in the ongoing PARAGON trial.

The phase III study, which began this summer, will enroll roughly 4,300 patients with symptomatic heart failure with preserved ejection fraction (HFpEF) in 37 countries. They are being randomized to the novel, first-in-class angiotensin receptor neprilysin inhibitor (ARNI) known for now as LCZ696 at 200 mg b.i.d. or valsartan at 160 mg b.i.d., PARAGON principal investigator Dr. Scott D. Solomon explained at the annual meeting of the Heart Failure Society of America.

The study is a bit of a gamble because, to date, there is no effective treatment for HFpEF, which accounts for at least half of all cases of heart failure. Four prior major clinical trials testing various candidate therapies have all gone down in flames, failing to achieve their primary endpoints, but there are multiple reasons to believe PARAGON will be different, according to Dr. Solomon, professor of medicine at Harvard Medical School, Boston.

For one thing, previous major trials enrolled some participants without clear evidence that they even had HFpEF. Not so in PARAGON, which requires subjects to have symptomatic heart failure, an ejection fraction of 45% or more, and evidence of structural heart disease along with either a hospitalization for heart failure within the previous 9 months or elevated natriuretic peptides.

Also, unlike the prior disappointing studies involving other agents, PARAGON is supported by positive findings in a phase II proof-of-concept study. In the phase II, double-blind PARAMOUNT trial, also led by Dr. Solomon, 301 patients with HFpEF were randomized to LCZ696 or valsartan for 36 weeks. The primary study endpoint was change in N-terminal of the prohormone brain natriuretic hormone (NT-proBNP), a biomarker of left ventricular wall stress, through 12 weeks. The result was positive, with a 23% greater reduction in elevated baseline levels in the LCZ696 group, compared with those on valsartan (Lancet 2012;380:1387-95).

By 36 weeks, the ARNI-treated patients also showed a significant reduction in left atrial volume as well as improvement in New York Heart Association functional class, the cardiologist added.

PARAGON features a novel primary endpoint: a composite of cardiovascular death and total hospitalizations for heart failure, rather than time to the first hospitalization, as used in previous trials. “Total hospitalizations for heart failure better captures the full burden of the disease,” Dr. Solomon explained.

Results of PARAGON are expected in 2019.

Dr. Solomon has received research grants and honoraria from Novartis, which is funding the PARAGON trial.

bjancin@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
What about LCZ696 for heart failure with preserved ejection fraction?
Display Headline
What about LCZ696 for heart failure with preserved ejection fraction?
Legacy Keywords
LCA696 ARNI PARAGON HFpEF
Legacy Keywords
LCA696 ARNI PARAGON HFpEF
Article Source

EXPERT ANALYSIS FROM THE HFSA ANNUAL SCIENTIFIC MEETING

PURLs Copyright

Inside the Article

FDA finalizes medical device cybersecurity guidance

Article Type
Changed
Tue, 05/03/2022 - 15:47
Display Headline
FDA finalizes medical device cybersecurity guidance

The Food and Drug Administration is calling on device manufacturers that have network-connected devices to consider cybersecurity risks as part of product design.

The agency finalized guidance recommending that manufacturers submit documentation to the FDA about identified risks and the controls in place to mitigate the risks, as well as about how manufacturers plan to update software as risks are discovered.

“There is no such thing as a threat-proof medical device,” Suzanne Schwartz, director of emergency preparedness/operations and medical countermeasures at the FDA’s Center for Devices and Radiological Health, said in a statement. “It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks.”

While directed at manufacturers, the guidance notes that medical device security “is a shared responsibility” across all stakeholders, including health care facilities, physicians, patients, and manufacturers.

FDA will host a 2-day workshop on Oct. 21-22, 2014, to discuss the guidance and collaborative approaches to medical device cybersecurity.

gtwachtman@frontlinemedcom.com

References

Author and Disclosure Information

Publications
Topics
Legacy Keywords
FDA, cyberattacks, cybersecurity, HACKING,
Sections
Author and Disclosure Information

Author and Disclosure Information

Related Articles

The Food and Drug Administration is calling on device manufacturers that have network-connected devices to consider cybersecurity risks as part of product design.

The agency finalized guidance recommending that manufacturers submit documentation to the FDA about identified risks and the controls in place to mitigate the risks, as well as about how manufacturers plan to update software as risks are discovered.

“There is no such thing as a threat-proof medical device,” Suzanne Schwartz, director of emergency preparedness/operations and medical countermeasures at the FDA’s Center for Devices and Radiological Health, said in a statement. “It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks.”

While directed at manufacturers, the guidance notes that medical device security “is a shared responsibility” across all stakeholders, including health care facilities, physicians, patients, and manufacturers.

FDA will host a 2-day workshop on Oct. 21-22, 2014, to discuss the guidance and collaborative approaches to medical device cybersecurity.

gtwachtman@frontlinemedcom.com

The Food and Drug Administration is calling on device manufacturers that have network-connected devices to consider cybersecurity risks as part of product design.

The agency finalized guidance recommending that manufacturers submit documentation to the FDA about identified risks and the controls in place to mitigate the risks, as well as about how manufacturers plan to update software as risks are discovered.

“There is no such thing as a threat-proof medical device,” Suzanne Schwartz, director of emergency preparedness/operations and medical countermeasures at the FDA’s Center for Devices and Radiological Health, said in a statement. “It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks.”

While directed at manufacturers, the guidance notes that medical device security “is a shared responsibility” across all stakeholders, including health care facilities, physicians, patients, and manufacturers.

FDA will host a 2-day workshop on Oct. 21-22, 2014, to discuss the guidance and collaborative approaches to medical device cybersecurity.

gtwachtman@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
FDA finalizes medical device cybersecurity guidance
Display Headline
FDA finalizes medical device cybersecurity guidance
Legacy Keywords
FDA, cyberattacks, cybersecurity, HACKING,
Legacy Keywords
FDA, cyberattacks, cybersecurity, HACKING,
Sections
Article Source

PURLs Copyright

Inside the Article

Type 2 diabetes boosts risk of death in heart failure patients by 70%

Article Type
Changed
Fri, 01/18/2019 - 13:59
Display Headline
Type 2 diabetes boosts risk of death in heart failure patients by 70%

VIENNA – Among patients with ischemic heart failure, type 2 diabetes increased the risk of death by 70% over 2 years.

Even patients with a prior revascularization were in danger, with a 60% increased risk of death. The findings were slightly better for patients with a preserved ejection fraction of at least 50%; type 2 diabetes increased their mortality risk by 40%, Dr. Anna Norhammar and Dr. Isabelle Johansson of Karolinska Institute, Stockholm, reported at the annual meeting of the European Society for the Study of Diabetes.

The results were drawn from the large Swedish Heart Failure Registry. It contains data on about 41,000 patients who have been treated for heart failure since 2003. Of these, 17,673 had ischemic heart failure, and 30% had both type 2 diabetes and ischemic heart failure.

These patients were younger than those without diabetes (75 vs. 77 years), and congestive heart failure of at least 6 months was present in 61% of those with diabetes and 54% of those without it. Those with diabetes had more severe heart failure, with a New York Heart Association class of III/IV in 53%, compared with 46% of those without diabetes, Dr. Norhammar reported.

Hypertension and atrial fibrillation were significantly more common among those with diabetes. A prior revascularization had occurred in 48% of those without diabetes, compared with 54% of those with diabetes.

In a multivariate model that adjusted for 29 variables, the investigators found that type 2 diabetes increased the risk of death by 70% over a median follow-up of 22 months. Prior revascularization cut the risk by 60%.

Dr. Johansson presented a separate analysis of patients who had a preserved ejection fraction of at least 50% (6,705). Of these, 1,658 had type 2 diabetes. Again, these patients were younger (76 vs. 78 years), more likely to have congestive heart failure (53% vs. 48%), and more likely to be in the NYHA class III/IV (44% vs. 39%). More of those with diabetes had concomitant ischemic heart disease, hypertension, atrial fibrillation, and valvular heart disease.

In this multivariate analysis, having type 2 diabetes increased the risk of death by 40%, Dr. Johansson said.

Dr. Norhammar and Dr. Johansson had no relevant financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

References

Click for Credit Link
Author and Disclosure Information

Publications
Topics
Legacy Keywords
ischemic heart failure, type 2 diabetes, revascularizatio, ejection fraction, Anna Norhammar, Isabelle Johansson, Karolinska Institute, Stockholm, European Society for the Study of Diabetes,
Sections
Click for Credit Link
Click for Credit Link
Author and Disclosure Information

Author and Disclosure Information

VIENNA – Among patients with ischemic heart failure, type 2 diabetes increased the risk of death by 70% over 2 years.

Even patients with a prior revascularization were in danger, with a 60% increased risk of death. The findings were slightly better for patients with a preserved ejection fraction of at least 50%; type 2 diabetes increased their mortality risk by 40%, Dr. Anna Norhammar and Dr. Isabelle Johansson of Karolinska Institute, Stockholm, reported at the annual meeting of the European Society for the Study of Diabetes.

The results were drawn from the large Swedish Heart Failure Registry. It contains data on about 41,000 patients who have been treated for heart failure since 2003. Of these, 17,673 had ischemic heart failure, and 30% had both type 2 diabetes and ischemic heart failure.

These patients were younger than those without diabetes (75 vs. 77 years), and congestive heart failure of at least 6 months was present in 61% of those with diabetes and 54% of those without it. Those with diabetes had more severe heart failure, with a New York Heart Association class of III/IV in 53%, compared with 46% of those without diabetes, Dr. Norhammar reported.

Hypertension and atrial fibrillation were significantly more common among those with diabetes. A prior revascularization had occurred in 48% of those without diabetes, compared with 54% of those with diabetes.

In a multivariate model that adjusted for 29 variables, the investigators found that type 2 diabetes increased the risk of death by 70% over a median follow-up of 22 months. Prior revascularization cut the risk by 60%.

Dr. Johansson presented a separate analysis of patients who had a preserved ejection fraction of at least 50% (6,705). Of these, 1,658 had type 2 diabetes. Again, these patients were younger (76 vs. 78 years), more likely to have congestive heart failure (53% vs. 48%), and more likely to be in the NYHA class III/IV (44% vs. 39%). More of those with diabetes had concomitant ischemic heart disease, hypertension, atrial fibrillation, and valvular heart disease.

In this multivariate analysis, having type 2 diabetes increased the risk of death by 40%, Dr. Johansson said.

Dr. Norhammar and Dr. Johansson had no relevant financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

VIENNA – Among patients with ischemic heart failure, type 2 diabetes increased the risk of death by 70% over 2 years.

Even patients with a prior revascularization were in danger, with a 60% increased risk of death. The findings were slightly better for patients with a preserved ejection fraction of at least 50%; type 2 diabetes increased their mortality risk by 40%, Dr. Anna Norhammar and Dr. Isabelle Johansson of Karolinska Institute, Stockholm, reported at the annual meeting of the European Society for the Study of Diabetes.

The results were drawn from the large Swedish Heart Failure Registry. It contains data on about 41,000 patients who have been treated for heart failure since 2003. Of these, 17,673 had ischemic heart failure, and 30% had both type 2 diabetes and ischemic heart failure.

These patients were younger than those without diabetes (75 vs. 77 years), and congestive heart failure of at least 6 months was present in 61% of those with diabetes and 54% of those without it. Those with diabetes had more severe heart failure, with a New York Heart Association class of III/IV in 53%, compared with 46% of those without diabetes, Dr. Norhammar reported.

Hypertension and atrial fibrillation were significantly more common among those with diabetes. A prior revascularization had occurred in 48% of those without diabetes, compared with 54% of those with diabetes.

In a multivariate model that adjusted for 29 variables, the investigators found that type 2 diabetes increased the risk of death by 70% over a median follow-up of 22 months. Prior revascularization cut the risk by 60%.

Dr. Johansson presented a separate analysis of patients who had a preserved ejection fraction of at least 50% (6,705). Of these, 1,658 had type 2 diabetes. Again, these patients were younger (76 vs. 78 years), more likely to have congestive heart failure (53% vs. 48%), and more likely to be in the NYHA class III/IV (44% vs. 39%). More of those with diabetes had concomitant ischemic heart disease, hypertension, atrial fibrillation, and valvular heart disease.

In this multivariate analysis, having type 2 diabetes increased the risk of death by 40%, Dr. Johansson said.

Dr. Norhammar and Dr. Johansson had no relevant financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

References

References

Publications
Publications
Topics
Article Type
Display Headline
Type 2 diabetes boosts risk of death in heart failure patients by 70%
Display Headline
Type 2 diabetes boosts risk of death in heart failure patients by 70%
Legacy Keywords
ischemic heart failure, type 2 diabetes, revascularizatio, ejection fraction, Anna Norhammar, Isabelle Johansson, Karolinska Institute, Stockholm, European Society for the Study of Diabetes,
Legacy Keywords
ischemic heart failure, type 2 diabetes, revascularizatio, ejection fraction, Anna Norhammar, Isabelle Johansson, Karolinska Institute, Stockholm, European Society for the Study of Diabetes,
Sections
Article Source

AT EASD 2014

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Among patients with ischemic heart failure, type 2 diabetes is associated with an increased mortality risk.

Major finding: Type 2 diabetes increased the risk of death by 70% in patients with ischemic heart disease.

Data source: A prospective database study of 41,000 patients with heart failure.

Disclosures: Dr. Norhammar and Dr. Johansson had no relevant financial disclosures.

Wearable defibrillator impresses as bridge to ICD decision

Article Type
Changed
Fri, 12/07/2018 - 20:18
Display Headline
Wearable defibrillator impresses as bridge to ICD decision

BARCELONA – Use of the LifeVest wearable cardioverter defibrillator for 3 months is a safe and effective means of buying time to decide whether to place a permanent implantable cardioverter defibrillator for primary prevention of sudden cardiac death in potential candidates, according to the first report from a large prospective U.S. registry.

The wearable cardioverter defibrillator (WCD) simultaneously provides patient monitoring and reliable protection against fatal arrhythmias while physicians wait to see if, for example, a patient’s left ventricular ejection fraction, depressed to less than 35% immediately post-MI, will recover over the first several months or if life-threatening arrhythmias will arise warranting implantable cardioverter defibrillator (ICD) implantation, Dr. Valentina Kutyifa explained while presenting the results of the WEARIT-II registry at the annual congress of the European Society of Cardiology.

Dr. Valentina Kutyifa

"The WCD seems to be a powerful risk-assessment tool to identify patients at a high risk for sudden cardiac death who need subsequent ICD implantation. The WCD can be used as a bridge to a decision for appropriate ICD implantation in patients with a low ejection fraction who are immediately post-MI, or following coronary revascularization, or with new-onset dilated cardiomyopathy who are at high risk for sudden cardiac death until stabilization, or who have an inherited arrhythmia or congenital disorder," said Dr. Kutyifa of the University of Rochester (N.Y.).

She reported on 2,000 U.S. patients in those categories who participated in the prospective WEARIT-II (Prospective Registry and Follow-Up of Patients Using the Wearable Defibrillator) registry. All received from their physicians a 3-month prescription for the LifeVest WCD, which is covered by Medicare and by most health plans. Of the 2,000 patients, 927 had a left ventricular ejection fraction (LVEF) of 35% or below owing to nonischemic cardiomyopathy, 805 had ischemic cardiomyopathy, and 268 had an inherited or congenital arrhythmogenic disorder, such as long QT syndrome or arrhythmogenic right ventricular dysplasia.

Participants’ median ejection fraction at enrollment was 25%, and 52% of subjects had heart failure symptoms at that time. Patients wore the WCD for a median of 22.5 hours per day, with no difference in wear time by disease etiology.

In terms of WCD safety, the inappropriate shock rate was just 0.5% in 2,000 patients during 3 months. No study deaths occurred related to unsuccessful attempts at termination of ventricular tachycardia (VT) or ventricular fibrillation (VF) by the WCD. Three patients died while wearing the WCD, and in all three cases the WCD detected asystole at the time of death.

During 90 days of WCD wear, 2.1% of patients experienced VT or VF, for an event rate of 22 per 100 person-years. The WCD administered a shock for VT/VF in 1.1% of patients. Sustained VT or VF occurred in 1.4% of patients, while 3.6% of participants experienced atrial arrhythmias or supraventricular tachycardia, with an event rate of 121 per 100 person-years.

At the end of the 3-month period of WCD use, 42% of patients with ischemic cardiomyopathy got an ICD, as did 36% of those with nonischemic cardiomyopathy and 46% who had a congenital or inherited condition. The main reason for not implanting an ICD was a boost in ejection fraction.

The WCD frequently detected arrhythmias which facilitated the decision whether to implant an ICD or not. Eighty-five percent of patients with VT/VF treated with a WCD shock got an ICD, as did 65% of those with sustained VT that terminated spontaneously during the wearable device’s detection time. Of patients with WCD-detected atrial arrhythmias, 48% received an ICD, as did 39% of those with no arrhythmias during the 3-month period.

Dr. Kutyifa characterized the WCD as helping to fill an unmet need for improved selection of patients for primary ICD therapy. In the landmark MADIT-II trial, for example, only 4% of patients received an appropriate ICD shock during 4 years of follow-up (N. Engl. J. Med. 2002;346:877-82).

Asked about the cost-effectiveness of WCD as a bridge to the ICD decision, she replied that such data weren’t included in the WEARIT-II registry.

"The up-front cost of the device may seem rather high, but if you think about the fact that if we use the WCD and are then able to make the decision to not implant an ICD in patients who don’t need it, we really need to look at the long-term savings: the cost of the ICD, battery changes, and issues of possible lead extraction. So I think long-term this management strategy would be cost-effective," the electrophysiologist said, adding that the WCD is also rentable.

At the congress-closing conference highlights overview session, Dr. Sylvia G. Priori singled out the WEARIT-II registry as one of the top developments in the field of arrhythmias presented at this year’s meeting. She noted that the WCD has been available for several years – Medicare covers it, as do most U.S. health plans – yet until now many physicians have wanted to see stronger evidence of safety and effectiveness before incorporating the WCD into their own practices. WEARIT-II, she said, provides that supporting evidence.

 

 

"This was quite an important study. It showed the device is able to recognize life-threatening arrhythmias, so it is safe, and it does not deliver an excessive number of inappropriate shocks. And there were no deaths related to the device," commented Dr. Priori of the University of Pavia (Italy).

"The take-home message is that, yes, we know there are patients where we are reluctant to immediately say that an ICD should be implanted forever, and now we should consider testing with this WCD, which has a low risk of inappropriate shocks and a good record in shocking patients out of the arrhythmia," she added.

The WEARIT-II registry is now expanding via enrollment of patients in Europe and Israel. The registry is funded by Zoll, which markets the WCD. Dr. Kutyifa reported having received research grants from the company as well as from other device manufacturers.

bjancin@frontlinemedcom.com

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
LifeVest, wearable cardioverter defibrillator, permanent, implantable, primary prevention, sudden cardiac death, WCD, fatal arrhythmias, ICD, Valentina Kutyifa, WEARIT-II, European Society of Cardiology, University of Rochester,
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

BARCELONA – Use of the LifeVest wearable cardioverter defibrillator for 3 months is a safe and effective means of buying time to decide whether to place a permanent implantable cardioverter defibrillator for primary prevention of sudden cardiac death in potential candidates, according to the first report from a large prospective U.S. registry.

The wearable cardioverter defibrillator (WCD) simultaneously provides patient monitoring and reliable protection against fatal arrhythmias while physicians wait to see if, for example, a patient’s left ventricular ejection fraction, depressed to less than 35% immediately post-MI, will recover over the first several months or if life-threatening arrhythmias will arise warranting implantable cardioverter defibrillator (ICD) implantation, Dr. Valentina Kutyifa explained while presenting the results of the WEARIT-II registry at the annual congress of the European Society of Cardiology.

Dr. Valentina Kutyifa

"The WCD seems to be a powerful risk-assessment tool to identify patients at a high risk for sudden cardiac death who need subsequent ICD implantation. The WCD can be used as a bridge to a decision for appropriate ICD implantation in patients with a low ejection fraction who are immediately post-MI, or following coronary revascularization, or with new-onset dilated cardiomyopathy who are at high risk for sudden cardiac death until stabilization, or who have an inherited arrhythmia or congenital disorder," said Dr. Kutyifa of the University of Rochester (N.Y.).

She reported on 2,000 U.S. patients in those categories who participated in the prospective WEARIT-II (Prospective Registry and Follow-Up of Patients Using the Wearable Defibrillator) registry. All received from their physicians a 3-month prescription for the LifeVest WCD, which is covered by Medicare and by most health plans. Of the 2,000 patients, 927 had a left ventricular ejection fraction (LVEF) of 35% or below owing to nonischemic cardiomyopathy, 805 had ischemic cardiomyopathy, and 268 had an inherited or congenital arrhythmogenic disorder, such as long QT syndrome or arrhythmogenic right ventricular dysplasia.

Participants’ median ejection fraction at enrollment was 25%, and 52% of subjects had heart failure symptoms at that time. Patients wore the WCD for a median of 22.5 hours per day, with no difference in wear time by disease etiology.

In terms of WCD safety, the inappropriate shock rate was just 0.5% in 2,000 patients during 3 months. No study deaths occurred related to unsuccessful attempts at termination of ventricular tachycardia (VT) or ventricular fibrillation (VF) by the WCD. Three patients died while wearing the WCD, and in all three cases the WCD detected asystole at the time of death.

During 90 days of WCD wear, 2.1% of patients experienced VT or VF, for an event rate of 22 per 100 person-years. The WCD administered a shock for VT/VF in 1.1% of patients. Sustained VT or VF occurred in 1.4% of patients, while 3.6% of participants experienced atrial arrhythmias or supraventricular tachycardia, with an event rate of 121 per 100 person-years.

At the end of the 3-month period of WCD use, 42% of patients with ischemic cardiomyopathy got an ICD, as did 36% of those with nonischemic cardiomyopathy and 46% who had a congenital or inherited condition. The main reason for not implanting an ICD was a boost in ejection fraction.

The WCD frequently detected arrhythmias which facilitated the decision whether to implant an ICD or not. Eighty-five percent of patients with VT/VF treated with a WCD shock got an ICD, as did 65% of those with sustained VT that terminated spontaneously during the wearable device’s detection time. Of patients with WCD-detected atrial arrhythmias, 48% received an ICD, as did 39% of those with no arrhythmias during the 3-month period.

Dr. Kutyifa characterized the WCD as helping to fill an unmet need for improved selection of patients for primary ICD therapy. In the landmark MADIT-II trial, for example, only 4% of patients received an appropriate ICD shock during 4 years of follow-up (N. Engl. J. Med. 2002;346:877-82).

Asked about the cost-effectiveness of WCD as a bridge to the ICD decision, she replied that such data weren’t included in the WEARIT-II registry.

"The up-front cost of the device may seem rather high, but if you think about the fact that if we use the WCD and are then able to make the decision to not implant an ICD in patients who don’t need it, we really need to look at the long-term savings: the cost of the ICD, battery changes, and issues of possible lead extraction. So I think long-term this management strategy would be cost-effective," the electrophysiologist said, adding that the WCD is also rentable.

At the congress-closing conference highlights overview session, Dr. Sylvia G. Priori singled out the WEARIT-II registry as one of the top developments in the field of arrhythmias presented at this year’s meeting. She noted that the WCD has been available for several years – Medicare covers it, as do most U.S. health plans – yet until now many physicians have wanted to see stronger evidence of safety and effectiveness before incorporating the WCD into their own practices. WEARIT-II, she said, provides that supporting evidence.

 

 

"This was quite an important study. It showed the device is able to recognize life-threatening arrhythmias, so it is safe, and it does not deliver an excessive number of inappropriate shocks. And there were no deaths related to the device," commented Dr. Priori of the University of Pavia (Italy).

"The take-home message is that, yes, we know there are patients where we are reluctant to immediately say that an ICD should be implanted forever, and now we should consider testing with this WCD, which has a low risk of inappropriate shocks and a good record in shocking patients out of the arrhythmia," she added.

The WEARIT-II registry is now expanding via enrollment of patients in Europe and Israel. The registry is funded by Zoll, which markets the WCD. Dr. Kutyifa reported having received research grants from the company as well as from other device manufacturers.

bjancin@frontlinemedcom.com

BARCELONA – Use of the LifeVest wearable cardioverter defibrillator for 3 months is a safe and effective means of buying time to decide whether to place a permanent implantable cardioverter defibrillator for primary prevention of sudden cardiac death in potential candidates, according to the first report from a large prospective U.S. registry.

The wearable cardioverter defibrillator (WCD) simultaneously provides patient monitoring and reliable protection against fatal arrhythmias while physicians wait to see if, for example, a patient’s left ventricular ejection fraction, depressed to less than 35% immediately post-MI, will recover over the first several months or if life-threatening arrhythmias will arise warranting implantable cardioverter defibrillator (ICD) implantation, Dr. Valentina Kutyifa explained while presenting the results of the WEARIT-II registry at the annual congress of the European Society of Cardiology.

Dr. Valentina Kutyifa

"The WCD seems to be a powerful risk-assessment tool to identify patients at a high risk for sudden cardiac death who need subsequent ICD implantation. The WCD can be used as a bridge to a decision for appropriate ICD implantation in patients with a low ejection fraction who are immediately post-MI, or following coronary revascularization, or with new-onset dilated cardiomyopathy who are at high risk for sudden cardiac death until stabilization, or who have an inherited arrhythmia or congenital disorder," said Dr. Kutyifa of the University of Rochester (N.Y.).

She reported on 2,000 U.S. patients in those categories who participated in the prospective WEARIT-II (Prospective Registry and Follow-Up of Patients Using the Wearable Defibrillator) registry. All received from their physicians a 3-month prescription for the LifeVest WCD, which is covered by Medicare and by most health plans. Of the 2,000 patients, 927 had a left ventricular ejection fraction (LVEF) of 35% or below owing to nonischemic cardiomyopathy, 805 had ischemic cardiomyopathy, and 268 had an inherited or congenital arrhythmogenic disorder, such as long QT syndrome or arrhythmogenic right ventricular dysplasia.

Participants’ median ejection fraction at enrollment was 25%, and 52% of subjects had heart failure symptoms at that time. Patients wore the WCD for a median of 22.5 hours per day, with no difference in wear time by disease etiology.

In terms of WCD safety, the inappropriate shock rate was just 0.5% in 2,000 patients during 3 months. No study deaths occurred related to unsuccessful attempts at termination of ventricular tachycardia (VT) or ventricular fibrillation (VF) by the WCD. Three patients died while wearing the WCD, and in all three cases the WCD detected asystole at the time of death.

During 90 days of WCD wear, 2.1% of patients experienced VT or VF, for an event rate of 22 per 100 person-years. The WCD administered a shock for VT/VF in 1.1% of patients. Sustained VT or VF occurred in 1.4% of patients, while 3.6% of participants experienced atrial arrhythmias or supraventricular tachycardia, with an event rate of 121 per 100 person-years.

At the end of the 3-month period of WCD use, 42% of patients with ischemic cardiomyopathy got an ICD, as did 36% of those with nonischemic cardiomyopathy and 46% who had a congenital or inherited condition. The main reason for not implanting an ICD was a boost in ejection fraction.

The WCD frequently detected arrhythmias which facilitated the decision whether to implant an ICD or not. Eighty-five percent of patients with VT/VF treated with a WCD shock got an ICD, as did 65% of those with sustained VT that terminated spontaneously during the wearable device’s detection time. Of patients with WCD-detected atrial arrhythmias, 48% received an ICD, as did 39% of those with no arrhythmias during the 3-month period.

Dr. Kutyifa characterized the WCD as helping to fill an unmet need for improved selection of patients for primary ICD therapy. In the landmark MADIT-II trial, for example, only 4% of patients received an appropriate ICD shock during 4 years of follow-up (N. Engl. J. Med. 2002;346:877-82).

Asked about the cost-effectiveness of WCD as a bridge to the ICD decision, she replied that such data weren’t included in the WEARIT-II registry.

"The up-front cost of the device may seem rather high, but if you think about the fact that if we use the WCD and are then able to make the decision to not implant an ICD in patients who don’t need it, we really need to look at the long-term savings: the cost of the ICD, battery changes, and issues of possible lead extraction. So I think long-term this management strategy would be cost-effective," the electrophysiologist said, adding that the WCD is also rentable.

At the congress-closing conference highlights overview session, Dr. Sylvia G. Priori singled out the WEARIT-II registry as one of the top developments in the field of arrhythmias presented at this year’s meeting. She noted that the WCD has been available for several years – Medicare covers it, as do most U.S. health plans – yet until now many physicians have wanted to see stronger evidence of safety and effectiveness before incorporating the WCD into their own practices. WEARIT-II, she said, provides that supporting evidence.

 

 

"This was quite an important study. It showed the device is able to recognize life-threatening arrhythmias, so it is safe, and it does not deliver an excessive number of inappropriate shocks. And there were no deaths related to the device," commented Dr. Priori of the University of Pavia (Italy).

"The take-home message is that, yes, we know there are patients where we are reluctant to immediately say that an ICD should be implanted forever, and now we should consider testing with this WCD, which has a low risk of inappropriate shocks and a good record in shocking patients out of the arrhythmia," she added.

The WEARIT-II registry is now expanding via enrollment of patients in Europe and Israel. The registry is funded by Zoll, which markets the WCD. Dr. Kutyifa reported having received research grants from the company as well as from other device manufacturers.

bjancin@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
Wearable defibrillator impresses as bridge to ICD decision
Display Headline
Wearable defibrillator impresses as bridge to ICD decision
Legacy Keywords
LifeVest, wearable cardioverter defibrillator, permanent, implantable, primary prevention, sudden cardiac death, WCD, fatal arrhythmias, ICD, Valentina Kutyifa, WEARIT-II, European Society of Cardiology, University of Rochester,
Legacy Keywords
LifeVest, wearable cardioverter defibrillator, permanent, implantable, primary prevention, sudden cardiac death, WCD, fatal arrhythmias, ICD, Valentina Kutyifa, WEARIT-II, European Society of Cardiology, University of Rochester,
Sections
Article Source

AT THE ESC CONGRESS 2014

PURLs Copyright

Inside the Article

Vitals

Key clinical point: The temporary use of a commercially available wearable cardioverter defibrillator buys physicians time to decide whether or not to take the big step of permanent implantable cardioverter defibrillator placement in potential candidates for whom questions exist.

Major finding: During 3 months use of the LifeVest wearable cardioverter defibrillator, the vest detected VT/VF and administered an arrhythmia-ending shock in 1.1% of device wearers with an LVEF of 35% or less.

Data source: The prospective WEARIT-II registry includes to date 2,000 patients who are potential candidates for prophylactic implantation of a permanent cardioverter defibrillator for primary prevention of sudden cardiac arrest.

Disclosures: The presenter reported receiving research grant support from Zoll, which funded the WEARIT-II registry.

Beta-blockers no help for heart failure with atrial fib

Article Type
Changed
Fri, 01/18/2019 - 13:56
Display Headline
Beta-blockers no help for heart failure with atrial fib

Beta-blocker therapy doesn’t reduce all-cause mortality, cardiovascular mortality, cardiovascular hospitalization, or stroke in patients with heart failure who also have atrial fibrillation, Dipak Kotecha, Ph.D., reported at the annual congress of the European Society of Cardiology in Barcelona.

In a meta-analysis that used the "arduous" process of analyzing individual-patient data from all the high-quality randomized controlled trials available, Dr. Kotecha and his associates found no evidence that beta-blockers prevent adverse clinical events in this patient population. "Beta-blockers should no longer be regarded as standard therapy to improve prognosis" in patients with concomitant heart failure (HF) and atrial fibrillation (AF), he said.

In contrast, the drugs are effective and are strongly recommended for patients with HF who are in sinus rhythm, Dr. Kotecha said in a paper presented at the meeting and simultaneously published online Sept. 2 (Lancet 2014 [doi:10.1016/S0140-6736(14)61373-8]).

Heart failure and atrial fibrillation are common disorders, and both are becoming more prevalent. They often coexist, and an estimated 14%-50% of patients who have symptomatic HF also have AF.

At present, both European and American guidelines advise the use of beta-blockers for symptomatic heart failure without regard to AF status, based on trials that predominantly enrolled patients in sinus rhythm. There have been concerns about the drugs’ efficacy in certain subgroups of patients, including those with AF. "Patients with AF are often prescribed beta-blockers for both prognostic benefit in HF and heart-rate control, although there is little and underpowered evidence for efficacy in terms of clinical outcomes," he noted.

Dr. Kotecha and his associates in the Beta-Blockers in Heart Failure Collaborative Group – a multinational organization "formed to provide definitive answers to open questions about HF and beta-blocker therapy" and to provide clinicians with clear guidance – reviewed data from 18,254 study participants who were followed for a mean of 1.5 years, which allowed a robust and adequately powered analysis of this issue. They included "only unconfounded head-to-head trials with recruitment of more than 300 patients and a planned follow-up of more than 6 months."

A total of 3,066 (17%) of the study participants had AF as well as heart failure, and 633 of them died during follow-up. "A consistent benefit of beta-blockers versus placebo was noted for all death or hospital admission outcomes in patients with sinus rhythm, but the differences were not significant in patients with AF," said Dr. Kotecha of the University of Birmingham (England) Centre for Cardiovascular Sciences.

"The substantial benefit identified in patients with sinus rhythm should not be extrapolated to patients with AF," he said.

It is important to note that beta-blockers did appear to be safe, with no increase in mortality or adverse events, compared with placebo. "This should reassure clinicians, particularly for patients with another indication for beta-blockers, such as MI or the need for rate control of rapid AF with ongoing symptoms," he added.

This study was funded by Menarini Farmaceutica Internazionale, and GlaxoSmithKline provided data extraction support. Neither pharmaceutical group had a role in data analysis or manuscript preparation. Dr. Kotecha is supported by the U.K. National Institute for Health Research and reported receiving grants and honoraria from Menarini. His associates reported ties to numerous device and pharmaceutical sources.

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
Beta-blocker, therapy, all-cause mortality, cardiovascular mortality, cardiovascular hospitalization, stroke, heart failure, atrial fibrillation, Dipak Kotecha, European Society of Cardiology, Barcelona, HF, AF,
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

Beta-blocker therapy doesn’t reduce all-cause mortality, cardiovascular mortality, cardiovascular hospitalization, or stroke in patients with heart failure who also have atrial fibrillation, Dipak Kotecha, Ph.D., reported at the annual congress of the European Society of Cardiology in Barcelona.

In a meta-analysis that used the "arduous" process of analyzing individual-patient data from all the high-quality randomized controlled trials available, Dr. Kotecha and his associates found no evidence that beta-blockers prevent adverse clinical events in this patient population. "Beta-blockers should no longer be regarded as standard therapy to improve prognosis" in patients with concomitant heart failure (HF) and atrial fibrillation (AF), he said.

In contrast, the drugs are effective and are strongly recommended for patients with HF who are in sinus rhythm, Dr. Kotecha said in a paper presented at the meeting and simultaneously published online Sept. 2 (Lancet 2014 [doi:10.1016/S0140-6736(14)61373-8]).

Heart failure and atrial fibrillation are common disorders, and both are becoming more prevalent. They often coexist, and an estimated 14%-50% of patients who have symptomatic HF also have AF.

At present, both European and American guidelines advise the use of beta-blockers for symptomatic heart failure without regard to AF status, based on trials that predominantly enrolled patients in sinus rhythm. There have been concerns about the drugs’ efficacy in certain subgroups of patients, including those with AF. "Patients with AF are often prescribed beta-blockers for both prognostic benefit in HF and heart-rate control, although there is little and underpowered evidence for efficacy in terms of clinical outcomes," he noted.

Dr. Kotecha and his associates in the Beta-Blockers in Heart Failure Collaborative Group – a multinational organization "formed to provide definitive answers to open questions about HF and beta-blocker therapy" and to provide clinicians with clear guidance – reviewed data from 18,254 study participants who were followed for a mean of 1.5 years, which allowed a robust and adequately powered analysis of this issue. They included "only unconfounded head-to-head trials with recruitment of more than 300 patients and a planned follow-up of more than 6 months."

A total of 3,066 (17%) of the study participants had AF as well as heart failure, and 633 of them died during follow-up. "A consistent benefit of beta-blockers versus placebo was noted for all death or hospital admission outcomes in patients with sinus rhythm, but the differences were not significant in patients with AF," said Dr. Kotecha of the University of Birmingham (England) Centre for Cardiovascular Sciences.

"The substantial benefit identified in patients with sinus rhythm should not be extrapolated to patients with AF," he said.

It is important to note that beta-blockers did appear to be safe, with no increase in mortality or adverse events, compared with placebo. "This should reassure clinicians, particularly for patients with another indication for beta-blockers, such as MI or the need for rate control of rapid AF with ongoing symptoms," he added.

This study was funded by Menarini Farmaceutica Internazionale, and GlaxoSmithKline provided data extraction support. Neither pharmaceutical group had a role in data analysis or manuscript preparation. Dr. Kotecha is supported by the U.K. National Institute for Health Research and reported receiving grants and honoraria from Menarini. His associates reported ties to numerous device and pharmaceutical sources.

Beta-blocker therapy doesn’t reduce all-cause mortality, cardiovascular mortality, cardiovascular hospitalization, or stroke in patients with heart failure who also have atrial fibrillation, Dipak Kotecha, Ph.D., reported at the annual congress of the European Society of Cardiology in Barcelona.

In a meta-analysis that used the "arduous" process of analyzing individual-patient data from all the high-quality randomized controlled trials available, Dr. Kotecha and his associates found no evidence that beta-blockers prevent adverse clinical events in this patient population. "Beta-blockers should no longer be regarded as standard therapy to improve prognosis" in patients with concomitant heart failure (HF) and atrial fibrillation (AF), he said.

In contrast, the drugs are effective and are strongly recommended for patients with HF who are in sinus rhythm, Dr. Kotecha said in a paper presented at the meeting and simultaneously published online Sept. 2 (Lancet 2014 [doi:10.1016/S0140-6736(14)61373-8]).

Heart failure and atrial fibrillation are common disorders, and both are becoming more prevalent. They often coexist, and an estimated 14%-50% of patients who have symptomatic HF also have AF.

At present, both European and American guidelines advise the use of beta-blockers for symptomatic heart failure without regard to AF status, based on trials that predominantly enrolled patients in sinus rhythm. There have been concerns about the drugs’ efficacy in certain subgroups of patients, including those with AF. "Patients with AF are often prescribed beta-blockers for both prognostic benefit in HF and heart-rate control, although there is little and underpowered evidence for efficacy in terms of clinical outcomes," he noted.

Dr. Kotecha and his associates in the Beta-Blockers in Heart Failure Collaborative Group – a multinational organization "formed to provide definitive answers to open questions about HF and beta-blocker therapy" and to provide clinicians with clear guidance – reviewed data from 18,254 study participants who were followed for a mean of 1.5 years, which allowed a robust and adequately powered analysis of this issue. They included "only unconfounded head-to-head trials with recruitment of more than 300 patients and a planned follow-up of more than 6 months."

A total of 3,066 (17%) of the study participants had AF as well as heart failure, and 633 of them died during follow-up. "A consistent benefit of beta-blockers versus placebo was noted for all death or hospital admission outcomes in patients with sinus rhythm, but the differences were not significant in patients with AF," said Dr. Kotecha of the University of Birmingham (England) Centre for Cardiovascular Sciences.

"The substantial benefit identified in patients with sinus rhythm should not be extrapolated to patients with AF," he said.

It is important to note that beta-blockers did appear to be safe, with no increase in mortality or adverse events, compared with placebo. "This should reassure clinicians, particularly for patients with another indication for beta-blockers, such as MI or the need for rate control of rapid AF with ongoing symptoms," he added.

This study was funded by Menarini Farmaceutica Internazionale, and GlaxoSmithKline provided data extraction support. Neither pharmaceutical group had a role in data analysis or manuscript preparation. Dr. Kotecha is supported by the U.K. National Institute for Health Research and reported receiving grants and honoraria from Menarini. His associates reported ties to numerous device and pharmaceutical sources.

References

References

Publications
Publications
Topics
Article Type
Display Headline
Beta-blockers no help for heart failure with atrial fib
Display Headline
Beta-blockers no help for heart failure with atrial fib
Legacy Keywords
Beta-blocker, therapy, all-cause mortality, cardiovascular mortality, cardiovascular hospitalization, stroke, heart failure, atrial fibrillation, Dipak Kotecha, European Society of Cardiology, Barcelona, HF, AF,
Legacy Keywords
Beta-blocker, therapy, all-cause mortality, cardiovascular mortality, cardiovascular hospitalization, stroke, heart failure, atrial fibrillation, Dipak Kotecha, European Society of Cardiology, Barcelona, HF, AF,
Sections
Article Source

FROM THE ESC CONGRESS 2014

PURLs Copyright

Inside the Article

Vitals

Key clinical point: The benefit of beta-blockers in patients with HF and sinus rhythm cannot be extended to those with HF and atrial fibrillation.

Major finding: A consistent benefit of beta-blockers versus placebo was noted for all-cause mortality, CV mortality, CV hospitalization, and stroke in patients with sinus rhythm, but the differences were not significant in patients with AF.

Data source: A metaanalysis of all large high-quality randomized controlled trials assessing mortality and CV outcomes for 18,254 adults with HF, including 3,066 with concomitant AF, who received either beta-blockers or placebo and were followed for a mean of 1.5 years.

Disclosures: This study was funded by Menarini Farmaceutica Internazionale, and GlaxoSmithKline provided data extraction support. Neither pharmaceutical group had a role in data analysis or manuscript preparation. Dr. Kotecha is supported by the U.K. National Institute for Health Research and reported receiving grants and honoraria from Menarini. His associates reported ties to numerous device and pharmaceutical sources.