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CMS Revisits VAD Coverage Criteria
The Centers for Medicare and Medicaid Services is revisiting the National Coverage Determination for ventricular assist devices.
CMS is seeking public comment on the clinical evidence supporting identification of patients whose outcomes would improve with ventricular assist device (VAD) placement, health care teams, and hospital standards that would optimize patient outcomes, including evidence to support the current requirement for certification of hospitals implanting VADs for destination therapy.
CMS added that it is particularly interested in comments that include clinical studies and other scientific information that provides evidence for improvement in short-and long-erm outcomes with VADs.
"My own personal opinion is that it’s a good thing that they’ve reopened the NCD," said Dr. Lee Goldberg, medical director of the heart failure and transplantation program at the University of Pennsylvania, Philadelphia.
"For one, the technology has really changed, the experience of the centers and physicians have changed over time ... and the criteria to certify various centers and surgeons involved is somewhat archaic and arbitrary, so tightening that up in the context of updating evidence and approach makes sense." The challenge, he added, is that there’s not enough clinical data to answer all of the CMS questions and inquiries.
The NCD reopening, announced on Feb. 7, follows a Medicare advisory group meeting in November that aimed to review the available evidence on the management of heart failure using VADs, including the value of VAD-specific certification for various facilities, and patient selection and outcomes.
During the Medicare Advisory (MEDCAC) meeting, heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.
Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.
CMS will accept comments for 30 days on the reopened NCD, and various entities, including the American College of Cardiology, are expected to submit comments. "We want to make sure that we’re putting forth things that are most important to impact CMS decision making," said Dr. Goldberg, chair of the ACC’s heart failure and transplant council. "For instance, the appropriate certification of hospitals, appropriate utilization of a heart care team. ... Also, currently we know transplant is superior to VAD therapy for long-term survival and therefore we want to ensure that patients do have access to transplant evaluation."
The CMS review includes VADs used for bridge-to-transplant and as destination therapy. It does not include devices that are used for temporary, in-hospital use.
The reconsideration was requested by Det Norske Veritas Healthcare Inc. (DNV) to include the DNV mechanical circulatory support certification program as an acceptable credential for facilities that qualify for Medicare reimbursement.
The 140 U.S. centers that place LVADs were expected to implant nearly 3,000 devices in 2012. Nearly 4,600 patients have received an LVAD since 2010.
"I personally think that they’re going to try and tighten up [the requirements] a little bit," said Dr. Goldberg. "And try to understand who’s too sick, and where’s the appropriate cut-off, and to try and maximize or improve long-term outcomes for VAD patients. Whether they’ll be able to come up with something that’s better than what we have, I don’t know." It’s too soon to tell whether the NCD reconsideration will have an impact on procedure volumes, he added.
Dr. Goldberg and Dr. Pinney had no relevant disclosures.
On Twitter @NaseemSMiller
The Centers for Medicare and Medicaid Services is revisiting the National Coverage Determination for ventricular assist devices.
CMS is seeking public comment on the clinical evidence supporting identification of patients whose outcomes would improve with ventricular assist device (VAD) placement, health care teams, and hospital standards that would optimize patient outcomes, including evidence to support the current requirement for certification of hospitals implanting VADs for destination therapy.
CMS added that it is particularly interested in comments that include clinical studies and other scientific information that provides evidence for improvement in short-and long-erm outcomes with VADs.
"My own personal opinion is that it’s a good thing that they’ve reopened the NCD," said Dr. Lee Goldberg, medical director of the heart failure and transplantation program at the University of Pennsylvania, Philadelphia.
"For one, the technology has really changed, the experience of the centers and physicians have changed over time ... and the criteria to certify various centers and surgeons involved is somewhat archaic and arbitrary, so tightening that up in the context of updating evidence and approach makes sense." The challenge, he added, is that there’s not enough clinical data to answer all of the CMS questions and inquiries.
The NCD reopening, announced on Feb. 7, follows a Medicare advisory group meeting in November that aimed to review the available evidence on the management of heart failure using VADs, including the value of VAD-specific certification for various facilities, and patient selection and outcomes.
During the Medicare Advisory (MEDCAC) meeting, heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.
Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.
CMS will accept comments for 30 days on the reopened NCD, and various entities, including the American College of Cardiology, are expected to submit comments. "We want to make sure that we’re putting forth things that are most important to impact CMS decision making," said Dr. Goldberg, chair of the ACC’s heart failure and transplant council. "For instance, the appropriate certification of hospitals, appropriate utilization of a heart care team. ... Also, currently we know transplant is superior to VAD therapy for long-term survival and therefore we want to ensure that patients do have access to transplant evaluation."
The CMS review includes VADs used for bridge-to-transplant and as destination therapy. It does not include devices that are used for temporary, in-hospital use.
The reconsideration was requested by Det Norske Veritas Healthcare Inc. (DNV) to include the DNV mechanical circulatory support certification program as an acceptable credential for facilities that qualify for Medicare reimbursement.
The 140 U.S. centers that place LVADs were expected to implant nearly 3,000 devices in 2012. Nearly 4,600 patients have received an LVAD since 2010.
"I personally think that they’re going to try and tighten up [the requirements] a little bit," said Dr. Goldberg. "And try to understand who’s too sick, and where’s the appropriate cut-off, and to try and maximize or improve long-term outcomes for VAD patients. Whether they’ll be able to come up with something that’s better than what we have, I don’t know." It’s too soon to tell whether the NCD reconsideration will have an impact on procedure volumes, he added.
Dr. Goldberg and Dr. Pinney had no relevant disclosures.
On Twitter @NaseemSMiller
The Centers for Medicare and Medicaid Services is revisiting the National Coverage Determination for ventricular assist devices.
CMS is seeking public comment on the clinical evidence supporting identification of patients whose outcomes would improve with ventricular assist device (VAD) placement, health care teams, and hospital standards that would optimize patient outcomes, including evidence to support the current requirement for certification of hospitals implanting VADs for destination therapy.
CMS added that it is particularly interested in comments that include clinical studies and other scientific information that provides evidence for improvement in short-and long-erm outcomes with VADs.
"My own personal opinion is that it’s a good thing that they’ve reopened the NCD," said Dr. Lee Goldberg, medical director of the heart failure and transplantation program at the University of Pennsylvania, Philadelphia.
"For one, the technology has really changed, the experience of the centers and physicians have changed over time ... and the criteria to certify various centers and surgeons involved is somewhat archaic and arbitrary, so tightening that up in the context of updating evidence and approach makes sense." The challenge, he added, is that there’s not enough clinical data to answer all of the CMS questions and inquiries.
The NCD reopening, announced on Feb. 7, follows a Medicare advisory group meeting in November that aimed to review the available evidence on the management of heart failure using VADs, including the value of VAD-specific certification for various facilities, and patient selection and outcomes.
During the Medicare Advisory (MEDCAC) meeting, heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.
Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.
CMS will accept comments for 30 days on the reopened NCD, and various entities, including the American College of Cardiology, are expected to submit comments. "We want to make sure that we’re putting forth things that are most important to impact CMS decision making," said Dr. Goldberg, chair of the ACC’s heart failure and transplant council. "For instance, the appropriate certification of hospitals, appropriate utilization of a heart care team. ... Also, currently we know transplant is superior to VAD therapy for long-term survival and therefore we want to ensure that patients do have access to transplant evaluation."
The CMS review includes VADs used for bridge-to-transplant and as destination therapy. It does not include devices that are used for temporary, in-hospital use.
The reconsideration was requested by Det Norske Veritas Healthcare Inc. (DNV) to include the DNV mechanical circulatory support certification program as an acceptable credential for facilities that qualify for Medicare reimbursement.
The 140 U.S. centers that place LVADs were expected to implant nearly 3,000 devices in 2012. Nearly 4,600 patients have received an LVAD since 2010.
"I personally think that they’re going to try and tighten up [the requirements] a little bit," said Dr. Goldberg. "And try to understand who’s too sick, and where’s the appropriate cut-off, and to try and maximize or improve long-term outcomes for VAD patients. Whether they’ll be able to come up with something that’s better than what we have, I don’t know." It’s too soon to tell whether the NCD reconsideration will have an impact on procedure volumes, he added.
Dr. Goldberg and Dr. Pinney had no relevant disclosures.
On Twitter @NaseemSMiller
Atrial fib ablation in heart failure shows promise
LOS ANGELES – A strategy of catheter ablation–based rhythm control in patients with long-standing persistent atrial fibrillation plus heart failure improved cardiopulmonary exercise capacity, quality of life, and neurohormonal status, compared with pharmacologic rate control in a single-center randomized trial.
The majority of improvement seen in these endpoints in the ARC-HF (Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure) trial occurred 3-12 months after the initial ablation procedure, Dr. David G. Jones reported at the annual scientific sessions of the American Heart Association.
"This may reflect progressive amelioration of the heart failure syndrome. And our findings may also have prognostic significance," said Dr. Jones of Imperial College London.
Indeed, although clinical outcomes weren’t included in the relatively small ARC-HF study, they were reported in the recently published 1,620-patient HF-ACTION (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure) trial (Circ. Heart Fail. 2012;5:579-85). And HF-ACTION showed that every 6% increase in peak oxygen uptake (VO2) was associated with an 8% lower risk of the combined endpoint of cardiovascular mortality or heart failure hospitalization and a 7% reduction in all-cause mortality.
"By comparison, ours was close to a 20% increase in peak VO2 at 1 year with ablation therapy," Dr. Jones observed.
The ARC-HF trial included 51 patients with continuous persistent atrial fibrillation (AF) for an average of 24 months, symptomatic systolic heart failure, and a left ventricular ejection fraction of 35% or less. Because it has been unclear whether restoration of sinus rhythm or pharmacologic rate control is the optimal management strategy in patients with AF and the common comorbidity of heart failure, the investigators randomized participants to catheter ablation of the arrhythmia or to rate control.
The primary endpoint was the change in peak VO2 at 12 months from a baseline of roughly 17 mL/kg per minute. Peak VO2 increased by a mean of 2.0 mL/kg per minute in the 25 patients in the ablation group while declining over time in the rate control group, for an impressive 12-month intergroup difference of 3.07 mL/kg per minute.
The ablation group also displayed significant improvements in quality of life as measured by the Minnesota Living With Heart Failure Questionnaire, as well as neurohormonal status as reflected in a reduction in brain natriuretic peptide levels. Data on other cardiac biomarkers are still being analyzed.
A significant reduction in baseline left atrial dilation was documented in the ablation group at 6 months and maintained at 12 months. The ablation group showed a nonsignificant trend toward improved left ventricular ejection fraction.
Dr. Jones stressed that the ablation procedures were long and challenging. They averaged 333 minutes in duration, including mapping, with fully 80 minutes of fluoroscopy time and 82 minutes of actual ablation.
Seven patients experienced recurrent atrial arrhythmias post ablation; five of them underwent a second ablation procedure and one had a third. The single-procedure success rate in achieving sinus rhythm at 12 months was 72%, with a multiprocedure success rate of 92%.
Of the 26 patients in the rate control group, 2 were in sinus rhythm at 12 months (including 1 patient who crossed over to catheter ablation), and 23 of the remaining 24 were optimally rate controlled, with a resting heart rate below 80 beats per minute and a maximum heart rate below 110 bpm during a 6-minute walk test.
Discussant Dr. Karl-Heinz Kuck called the ARC-HF results "remarkable." So much so, in fact, that he doesn’t think catheter ablation can be recommended for now in patients with long-standing persistent AF and heart failure, because the single-center ARC-HF results are out of step with those reported in observational series. Better, he said, to wait for the results of ongoing, much larger multicenter randomized trials, including CASTLE-AF as well as AMICA, for which he serves as principal investigator.
Among Dr. Kuck’s concerns was the whopping 2.0-mL/kg per minute increase in peak VO2 reported in ARC-HF. To put that in perspective, the major randomized trials of cardiac resynchronization therapy and cardiac contractility modulation therapy for heart failure achieved increases of only 0.7-1.0 mL/kg per minute.
Also, a recent report from Dr. Kuck and his coinvestigators in the Hamburg Sequential Ablation Group, which involved 202 patients who underwent catheter ablation for long-standing persistent AF, showed only 36% were in sinus rhythm at 12 months after a single procedure and 60% after multiple procedures. Those success rates are substantially lower than in ARC-HF, noted Dr. Kuck, head of the cardiology department at St. Georg Hospital, Hamburg, Germany.
The 5-year success rates in the large Hamburg series were 20% and 45% after single and multiple ablation procedures, respectively. Success rates were far better in patients with a history of less than 2 years of persistent AF than in those who were arrhythmic for longer (J. Am. Coll. Cardiol. 2012;60:1921-9).
The ARC-HF study was supported by research grants from the Royal Brompton & Harefield NHS Foundation Trust. Dr. Jones reported having no financial conflicts. Dr. Kuck is on the speakers bureaus for Biosense Webster, Medtronic, St. Jude Medical, Abbott, Cardiofocus, and Biotronik.
LOS ANGELES – A strategy of catheter ablation–based rhythm control in patients with long-standing persistent atrial fibrillation plus heart failure improved cardiopulmonary exercise capacity, quality of life, and neurohormonal status, compared with pharmacologic rate control in a single-center randomized trial.
The majority of improvement seen in these endpoints in the ARC-HF (Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure) trial occurred 3-12 months after the initial ablation procedure, Dr. David G. Jones reported at the annual scientific sessions of the American Heart Association.
"This may reflect progressive amelioration of the heart failure syndrome. And our findings may also have prognostic significance," said Dr. Jones of Imperial College London.
Indeed, although clinical outcomes weren’t included in the relatively small ARC-HF study, they were reported in the recently published 1,620-patient HF-ACTION (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure) trial (Circ. Heart Fail. 2012;5:579-85). And HF-ACTION showed that every 6% increase in peak oxygen uptake (VO2) was associated with an 8% lower risk of the combined endpoint of cardiovascular mortality or heart failure hospitalization and a 7% reduction in all-cause mortality.
"By comparison, ours was close to a 20% increase in peak VO2 at 1 year with ablation therapy," Dr. Jones observed.
The ARC-HF trial included 51 patients with continuous persistent atrial fibrillation (AF) for an average of 24 months, symptomatic systolic heart failure, and a left ventricular ejection fraction of 35% or less. Because it has been unclear whether restoration of sinus rhythm or pharmacologic rate control is the optimal management strategy in patients with AF and the common comorbidity of heart failure, the investigators randomized participants to catheter ablation of the arrhythmia or to rate control.
The primary endpoint was the change in peak VO2 at 12 months from a baseline of roughly 17 mL/kg per minute. Peak VO2 increased by a mean of 2.0 mL/kg per minute in the 25 patients in the ablation group while declining over time in the rate control group, for an impressive 12-month intergroup difference of 3.07 mL/kg per minute.
The ablation group also displayed significant improvements in quality of life as measured by the Minnesota Living With Heart Failure Questionnaire, as well as neurohormonal status as reflected in a reduction in brain natriuretic peptide levels. Data on other cardiac biomarkers are still being analyzed.
A significant reduction in baseline left atrial dilation was documented in the ablation group at 6 months and maintained at 12 months. The ablation group showed a nonsignificant trend toward improved left ventricular ejection fraction.
Dr. Jones stressed that the ablation procedures were long and challenging. They averaged 333 minutes in duration, including mapping, with fully 80 minutes of fluoroscopy time and 82 minutes of actual ablation.
Seven patients experienced recurrent atrial arrhythmias post ablation; five of them underwent a second ablation procedure and one had a third. The single-procedure success rate in achieving sinus rhythm at 12 months was 72%, with a multiprocedure success rate of 92%.
Of the 26 patients in the rate control group, 2 were in sinus rhythm at 12 months (including 1 patient who crossed over to catheter ablation), and 23 of the remaining 24 were optimally rate controlled, with a resting heart rate below 80 beats per minute and a maximum heart rate below 110 bpm during a 6-minute walk test.
Discussant Dr. Karl-Heinz Kuck called the ARC-HF results "remarkable." So much so, in fact, that he doesn’t think catheter ablation can be recommended for now in patients with long-standing persistent AF and heart failure, because the single-center ARC-HF results are out of step with those reported in observational series. Better, he said, to wait for the results of ongoing, much larger multicenter randomized trials, including CASTLE-AF as well as AMICA, for which he serves as principal investigator.
Among Dr. Kuck’s concerns was the whopping 2.0-mL/kg per minute increase in peak VO2 reported in ARC-HF. To put that in perspective, the major randomized trials of cardiac resynchronization therapy and cardiac contractility modulation therapy for heart failure achieved increases of only 0.7-1.0 mL/kg per minute.
Also, a recent report from Dr. Kuck and his coinvestigators in the Hamburg Sequential Ablation Group, which involved 202 patients who underwent catheter ablation for long-standing persistent AF, showed only 36% were in sinus rhythm at 12 months after a single procedure and 60% after multiple procedures. Those success rates are substantially lower than in ARC-HF, noted Dr. Kuck, head of the cardiology department at St. Georg Hospital, Hamburg, Germany.
The 5-year success rates in the large Hamburg series were 20% and 45% after single and multiple ablation procedures, respectively. Success rates were far better in patients with a history of less than 2 years of persistent AF than in those who were arrhythmic for longer (J. Am. Coll. Cardiol. 2012;60:1921-9).
The ARC-HF study was supported by research grants from the Royal Brompton & Harefield NHS Foundation Trust. Dr. Jones reported having no financial conflicts. Dr. Kuck is on the speakers bureaus for Biosense Webster, Medtronic, St. Jude Medical, Abbott, Cardiofocus, and Biotronik.
LOS ANGELES – A strategy of catheter ablation–based rhythm control in patients with long-standing persistent atrial fibrillation plus heart failure improved cardiopulmonary exercise capacity, quality of life, and neurohormonal status, compared with pharmacologic rate control in a single-center randomized trial.
The majority of improvement seen in these endpoints in the ARC-HF (Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure) trial occurred 3-12 months after the initial ablation procedure, Dr. David G. Jones reported at the annual scientific sessions of the American Heart Association.
"This may reflect progressive amelioration of the heart failure syndrome. And our findings may also have prognostic significance," said Dr. Jones of Imperial College London.
Indeed, although clinical outcomes weren’t included in the relatively small ARC-HF study, they were reported in the recently published 1,620-patient HF-ACTION (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure) trial (Circ. Heart Fail. 2012;5:579-85). And HF-ACTION showed that every 6% increase in peak oxygen uptake (VO2) was associated with an 8% lower risk of the combined endpoint of cardiovascular mortality or heart failure hospitalization and a 7% reduction in all-cause mortality.
"By comparison, ours was close to a 20% increase in peak VO2 at 1 year with ablation therapy," Dr. Jones observed.
The ARC-HF trial included 51 patients with continuous persistent atrial fibrillation (AF) for an average of 24 months, symptomatic systolic heart failure, and a left ventricular ejection fraction of 35% or less. Because it has been unclear whether restoration of sinus rhythm or pharmacologic rate control is the optimal management strategy in patients with AF and the common comorbidity of heart failure, the investigators randomized participants to catheter ablation of the arrhythmia or to rate control.
The primary endpoint was the change in peak VO2 at 12 months from a baseline of roughly 17 mL/kg per minute. Peak VO2 increased by a mean of 2.0 mL/kg per minute in the 25 patients in the ablation group while declining over time in the rate control group, for an impressive 12-month intergroup difference of 3.07 mL/kg per minute.
The ablation group also displayed significant improvements in quality of life as measured by the Minnesota Living With Heart Failure Questionnaire, as well as neurohormonal status as reflected in a reduction in brain natriuretic peptide levels. Data on other cardiac biomarkers are still being analyzed.
A significant reduction in baseline left atrial dilation was documented in the ablation group at 6 months and maintained at 12 months. The ablation group showed a nonsignificant trend toward improved left ventricular ejection fraction.
Dr. Jones stressed that the ablation procedures were long and challenging. They averaged 333 minutes in duration, including mapping, with fully 80 minutes of fluoroscopy time and 82 minutes of actual ablation.
Seven patients experienced recurrent atrial arrhythmias post ablation; five of them underwent a second ablation procedure and one had a third. The single-procedure success rate in achieving sinus rhythm at 12 months was 72%, with a multiprocedure success rate of 92%.
Of the 26 patients in the rate control group, 2 were in sinus rhythm at 12 months (including 1 patient who crossed over to catheter ablation), and 23 of the remaining 24 were optimally rate controlled, with a resting heart rate below 80 beats per minute and a maximum heart rate below 110 bpm during a 6-minute walk test.
Discussant Dr. Karl-Heinz Kuck called the ARC-HF results "remarkable." So much so, in fact, that he doesn’t think catheter ablation can be recommended for now in patients with long-standing persistent AF and heart failure, because the single-center ARC-HF results are out of step with those reported in observational series. Better, he said, to wait for the results of ongoing, much larger multicenter randomized trials, including CASTLE-AF as well as AMICA, for which he serves as principal investigator.
Among Dr. Kuck’s concerns was the whopping 2.0-mL/kg per minute increase in peak VO2 reported in ARC-HF. To put that in perspective, the major randomized trials of cardiac resynchronization therapy and cardiac contractility modulation therapy for heart failure achieved increases of only 0.7-1.0 mL/kg per minute.
Also, a recent report from Dr. Kuck and his coinvestigators in the Hamburg Sequential Ablation Group, which involved 202 patients who underwent catheter ablation for long-standing persistent AF, showed only 36% were in sinus rhythm at 12 months after a single procedure and 60% after multiple procedures. Those success rates are substantially lower than in ARC-HF, noted Dr. Kuck, head of the cardiology department at St. Georg Hospital, Hamburg, Germany.
The 5-year success rates in the large Hamburg series were 20% and 45% after single and multiple ablation procedures, respectively. Success rates were far better in patients with a history of less than 2 years of persistent AF than in those who were arrhythmic for longer (J. Am. Coll. Cardiol. 2012;60:1921-9).
The ARC-HF study was supported by research grants from the Royal Brompton & Harefield NHS Foundation Trust. Dr. Jones reported having no financial conflicts. Dr. Kuck is on the speakers bureaus for Biosense Webster, Medtronic, St. Jude Medical, Abbott, Cardiofocus, and Biotronik.
AT THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN HEART ASSOCIATION
Major Finding: Patients with long-standing persistent atrial fibrillation and systolic heart failure averaged a 3.07-mL/kg per minute increase in peak VO2 12 months after undergoing catheter ablation of their arrhythmia, compared with patients assigned to a strategy of pharmacologic rate control.
Data Source: The ARC-HF trial was a single-center randomized trial in which endpoints were assessed by investigators blinded as to treatment arm.
Disclosures: The ARC-HF study was supported by research grants from the Royal Brompton & Harefield NHS Foundation Trust. Dr. Jones reported having no financial conflicts. Dr. Kuck is on the speakers bureaus for Biosense Webster, Medtronic, St. Jude Medical, Abbott, Cardiofocus, and Biotronik.
Comprehensive mechanical circulatory support guidelines issued
As a further sign of how much mechanical circulatory support for advanced heart failure has matured, the International Society of Heart and Lung Transplantation issued on Jan. 10 the first comprehensive guidelines for all phases of evaluating, implanting, and managing patients who receive left ventricular assist devices or related equipment.
"Traditionally management of patients with mechanical circulatory support [MCS] was very center specific, but because the number of treated patients has increased, and because patients now live with these devices for years, we reached a point where we needed best practices guidelines, an expert consensus on what is the best way to approach this treatment" said Dr. Salpy V. Pamboukian, a cardiologist and one of three cochairs of the guidelines-writing project.
"When MSC started, the role of the devices was as a bridge to heart transplantation, but the field has evolved over the past decade and now MCS for destination therapy has opened a new array of patients who could benefit from these devices," said Dr. Pamboukian, medical director of the MCS device program at the University of Alabama, Birmingham. "We hope these guidelines will serve as a springboard for further research into the long-term management of these patients," she said in an interview.
"As pumps improve and the number of patients with advanced heart failure increases more and more patients will receive a ventricular assist device [VAD], and heart transplant will grow less relevant. These guidelines are much more comprehensive [than anything previously published] and they represent the opinions of the physicians, surgeons, nurses, and other providers who care for these patients," said Dr. David S. Feldman, a cardiologist who is director of the heart failure, VAD, and cardiac transplantation program at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and another cochair of the guidelines committee.
The guidelines, which took about 3 years to produce, came from a committee of 35 health care providers, with initial review by three independent experts followed by additional peer review and then a period of open comment from the society’s membership. The 146-page document consists of more than 250 individual recommendations presented in five sections: patient selection; risk management prior to surgery; intraoperative procedures and immediate postoperative management; in-patient management during the immediate postoperative period; and long-term outpatient management (J. Heart Lung Transplant. 2013;32:157-87).
The writing committee admitted up front in the paper that most of the recommendations are consensus opinions with no clear evidence base. "It’s a limitation," admitted Dr. Pamboukian, "but you need a common approach to patients. Even a busy center may put in 50 or 60 VADs a year. Hopefully, a result of the guidelines is that they will help centers get together and produce the critical mass of patients needed to conduct meaningful trials. It was time to get something on paper; the new guidelines are what we will now work off of." But despite an absence of evidence on which to base many recommendations, "I was pleasantly surprised that there was more consensus than controversy. There was more commonality in our approaches than differences," she added.
The most limited number of recommendations came from the third task force of the panel, which handled intraoperative procedures and immediate postoperative care. Though this section runs 17 pages and deals with topics such as anesthesia, implantation techniques, establishing hemostasis, performing concomitant procedures, methods for explantation, and management of postoperative hemodynamics and bleeding, it contains just three specific recommendations, all dealing with anesthesia. "There are essentially no studies that have looked at how to make things better in the surgical suite," explained Dr. Feldman.
"It’s very challenging to standardize a surgical procedure," added Dr. Pamboukian. "We tried to summarize useful practices, but consensus-based recommendations are difficult to do."
Another topic the guidelines finesse is patient selection. The field is currently trying to sort out the best stage of advanced heart failure for patients to receive mechanical circulatory support. "You’d be amazed at the disparity of who gets these devices now," Dr. Feldman said. In addition, the guideline writing committee decided to defer definitive choices until results are available from a large study starting later this year. The study, Evaluation of VAD Intervention Before Inotropic Therapy (REVIVE-IT), will examine the outcomes of patients with advanced New York Heart Association stage III heart failure who receive a VAD. "It didn’t seem appropriate to address this because of the trial," he added.
Both Dr. Pamboukian and Dr. Feldman agreed that the newly released guidelines will likely be in place for only a couple of years before a revision comes out, testament to the rapid changes in this field. Dr. Feldman cited new VADs from at least two manufacturers expected to enter first-in-man studies this year, and the continued snowballing of VAD implantation rates. The most recent 2012 numbers (through Sept. 30, 2012) from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed nearly 2,000 VADS getting implanted into U.S. patients last year, the highest annual rate ever.
"Because the field is growing, a lot of new centers want to establish programs. We want this treatment to reach as many appropriate patients as possible, but we want it to grow responsibly. These guidelines help establish the best practices, and help ensure that patients get the best care wherever they go," Dr. Pamboukian said.
Dr. Pamboukian said that she had no disclosures. Dr. Feldman said that he has received research support from Terumo.
As a further sign of how much mechanical circulatory support for advanced heart failure has matured, the International Society of Heart and Lung Transplantation issued on Jan. 10 the first comprehensive guidelines for all phases of evaluating, implanting, and managing patients who receive left ventricular assist devices or related equipment.
"Traditionally management of patients with mechanical circulatory support [MCS] was very center specific, but because the number of treated patients has increased, and because patients now live with these devices for years, we reached a point where we needed best practices guidelines, an expert consensus on what is the best way to approach this treatment" said Dr. Salpy V. Pamboukian, a cardiologist and one of three cochairs of the guidelines-writing project.
"When MSC started, the role of the devices was as a bridge to heart transplantation, but the field has evolved over the past decade and now MCS for destination therapy has opened a new array of patients who could benefit from these devices," said Dr. Pamboukian, medical director of the MCS device program at the University of Alabama, Birmingham. "We hope these guidelines will serve as a springboard for further research into the long-term management of these patients," she said in an interview.
"As pumps improve and the number of patients with advanced heart failure increases more and more patients will receive a ventricular assist device [VAD], and heart transplant will grow less relevant. These guidelines are much more comprehensive [than anything previously published] and they represent the opinions of the physicians, surgeons, nurses, and other providers who care for these patients," said Dr. David S. Feldman, a cardiologist who is director of the heart failure, VAD, and cardiac transplantation program at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and another cochair of the guidelines committee.
The guidelines, which took about 3 years to produce, came from a committee of 35 health care providers, with initial review by three independent experts followed by additional peer review and then a period of open comment from the society’s membership. The 146-page document consists of more than 250 individual recommendations presented in five sections: patient selection; risk management prior to surgery; intraoperative procedures and immediate postoperative management; in-patient management during the immediate postoperative period; and long-term outpatient management (J. Heart Lung Transplant. 2013;32:157-87).
The writing committee admitted up front in the paper that most of the recommendations are consensus opinions with no clear evidence base. "It’s a limitation," admitted Dr. Pamboukian, "but you need a common approach to patients. Even a busy center may put in 50 or 60 VADs a year. Hopefully, a result of the guidelines is that they will help centers get together and produce the critical mass of patients needed to conduct meaningful trials. It was time to get something on paper; the new guidelines are what we will now work off of." But despite an absence of evidence on which to base many recommendations, "I was pleasantly surprised that there was more consensus than controversy. There was more commonality in our approaches than differences," she added.
The most limited number of recommendations came from the third task force of the panel, which handled intraoperative procedures and immediate postoperative care. Though this section runs 17 pages and deals with topics such as anesthesia, implantation techniques, establishing hemostasis, performing concomitant procedures, methods for explantation, and management of postoperative hemodynamics and bleeding, it contains just three specific recommendations, all dealing with anesthesia. "There are essentially no studies that have looked at how to make things better in the surgical suite," explained Dr. Feldman.
"It’s very challenging to standardize a surgical procedure," added Dr. Pamboukian. "We tried to summarize useful practices, but consensus-based recommendations are difficult to do."
Another topic the guidelines finesse is patient selection. The field is currently trying to sort out the best stage of advanced heart failure for patients to receive mechanical circulatory support. "You’d be amazed at the disparity of who gets these devices now," Dr. Feldman said. In addition, the guideline writing committee decided to defer definitive choices until results are available from a large study starting later this year. The study, Evaluation of VAD Intervention Before Inotropic Therapy (REVIVE-IT), will examine the outcomes of patients with advanced New York Heart Association stage III heart failure who receive a VAD. "It didn’t seem appropriate to address this because of the trial," he added.
Both Dr. Pamboukian and Dr. Feldman agreed that the newly released guidelines will likely be in place for only a couple of years before a revision comes out, testament to the rapid changes in this field. Dr. Feldman cited new VADs from at least two manufacturers expected to enter first-in-man studies this year, and the continued snowballing of VAD implantation rates. The most recent 2012 numbers (through Sept. 30, 2012) from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed nearly 2,000 VADS getting implanted into U.S. patients last year, the highest annual rate ever.
"Because the field is growing, a lot of new centers want to establish programs. We want this treatment to reach as many appropriate patients as possible, but we want it to grow responsibly. These guidelines help establish the best practices, and help ensure that patients get the best care wherever they go," Dr. Pamboukian said.
Dr. Pamboukian said that she had no disclosures. Dr. Feldman said that he has received research support from Terumo.
As a further sign of how much mechanical circulatory support for advanced heart failure has matured, the International Society of Heart and Lung Transplantation issued on Jan. 10 the first comprehensive guidelines for all phases of evaluating, implanting, and managing patients who receive left ventricular assist devices or related equipment.
"Traditionally management of patients with mechanical circulatory support [MCS] was very center specific, but because the number of treated patients has increased, and because patients now live with these devices for years, we reached a point where we needed best practices guidelines, an expert consensus on what is the best way to approach this treatment" said Dr. Salpy V. Pamboukian, a cardiologist and one of three cochairs of the guidelines-writing project.
"When MSC started, the role of the devices was as a bridge to heart transplantation, but the field has evolved over the past decade and now MCS for destination therapy has opened a new array of patients who could benefit from these devices," said Dr. Pamboukian, medical director of the MCS device program at the University of Alabama, Birmingham. "We hope these guidelines will serve as a springboard for further research into the long-term management of these patients," she said in an interview.
"As pumps improve and the number of patients with advanced heart failure increases more and more patients will receive a ventricular assist device [VAD], and heart transplant will grow less relevant. These guidelines are much more comprehensive [than anything previously published] and they represent the opinions of the physicians, surgeons, nurses, and other providers who care for these patients," said Dr. David S. Feldman, a cardiologist who is director of the heart failure, VAD, and cardiac transplantation program at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and another cochair of the guidelines committee.
The guidelines, which took about 3 years to produce, came from a committee of 35 health care providers, with initial review by three independent experts followed by additional peer review and then a period of open comment from the society’s membership. The 146-page document consists of more than 250 individual recommendations presented in five sections: patient selection; risk management prior to surgery; intraoperative procedures and immediate postoperative management; in-patient management during the immediate postoperative period; and long-term outpatient management (J. Heart Lung Transplant. 2013;32:157-87).
The writing committee admitted up front in the paper that most of the recommendations are consensus opinions with no clear evidence base. "It’s a limitation," admitted Dr. Pamboukian, "but you need a common approach to patients. Even a busy center may put in 50 or 60 VADs a year. Hopefully, a result of the guidelines is that they will help centers get together and produce the critical mass of patients needed to conduct meaningful trials. It was time to get something on paper; the new guidelines are what we will now work off of." But despite an absence of evidence on which to base many recommendations, "I was pleasantly surprised that there was more consensus than controversy. There was more commonality in our approaches than differences," she added.
The most limited number of recommendations came from the third task force of the panel, which handled intraoperative procedures and immediate postoperative care. Though this section runs 17 pages and deals with topics such as anesthesia, implantation techniques, establishing hemostasis, performing concomitant procedures, methods for explantation, and management of postoperative hemodynamics and bleeding, it contains just three specific recommendations, all dealing with anesthesia. "There are essentially no studies that have looked at how to make things better in the surgical suite," explained Dr. Feldman.
"It’s very challenging to standardize a surgical procedure," added Dr. Pamboukian. "We tried to summarize useful practices, but consensus-based recommendations are difficult to do."
Another topic the guidelines finesse is patient selection. The field is currently trying to sort out the best stage of advanced heart failure for patients to receive mechanical circulatory support. "You’d be amazed at the disparity of who gets these devices now," Dr. Feldman said. In addition, the guideline writing committee decided to defer definitive choices until results are available from a large study starting later this year. The study, Evaluation of VAD Intervention Before Inotropic Therapy (REVIVE-IT), will examine the outcomes of patients with advanced New York Heart Association stage III heart failure who receive a VAD. "It didn’t seem appropriate to address this because of the trial," he added.
Both Dr. Pamboukian and Dr. Feldman agreed that the newly released guidelines will likely be in place for only a couple of years before a revision comes out, testament to the rapid changes in this field. Dr. Feldman cited new VADs from at least two manufacturers expected to enter first-in-man studies this year, and the continued snowballing of VAD implantation rates. The most recent 2012 numbers (through Sept. 30, 2012) from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed nearly 2,000 VADS getting implanted into U.S. patients last year, the highest annual rate ever.
"Because the field is growing, a lot of new centers want to establish programs. We want this treatment to reach as many appropriate patients as possible, but we want it to grow responsibly. These guidelines help establish the best practices, and help ensure that patients get the best care wherever they go," Dr. Pamboukian said.
Dr. Pamboukian said that she had no disclosures. Dr. Feldman said that he has received research support from Terumo.
FROM THE JOURNAL OF HEART AND LUNG TRANSPLANTATION
Vitamin D lowered aldosterone in heart failure
LOS ANGELES – Oral vitamin D3 may have a future as adjunctive therapy in patients with heart failure, according to Dr. Rebecca S. Boxer.
Six months of oral vitamin D3 therapy at 50,000 IU/wk resulted in a 37% decrease in serum aldosterone level in a randomized, double-blind, placebo-controlled trial conducted in vitamin D–deficient patients with heart failure.
Moreover, parathyroid hormone levels, which were elevated at baseline, fell by 41% in the active treatment arm, she reported at the annual scientific sessions of the American Heart Association.
The study involved 64 patients with New York Heart Association class II-IV heart failure, all having a baseline serum vitamin D level below 20 ng/mL. All participants were on maximum tolerated doses of standard heart failure medications. The patients were randomized to oral vitamin D3 at 50,000 IU/wk plus 400 mg of calcium citrate twice daily for 6 months or to calcium plus placebo.
Mean serum vitamin D levels climbed from 19 ng/mL to 60 ng/mL in treated patients while remaining unchanged over time in controls.
Serum aldosterone levels fell from 10.0 ng/mL to 6.3 ng/dL in the active treatment group and remained static in controls. The mean serum parathyroid hormone level dropped from 62.3 pg/mL to 37.1 pg/mL with vitamin D therapy but stayed steady in controls, said Dr. Boxer of Case Western Reserve University, Cleveland.
The primary endpoint in this randomized trial was change in aerobic capacity; vitamin D supplementation had no effect on this endpoint. Nor did it have any significant impact on heart failure symptoms, echocardiographic findings, body weight, blood pressure, serum renin, or C-reactive protein levels in this relatively small study.
Nonetheless, the finding of a moderate reduction in serum aldosterone level indicates that the effects of vitamin D3 on the renin-angiotensin-aldosterone system (RAAS) in patients with heart failure warrants further study, including assessment of possible long-term clinical benefit.
Dr. Boxer pointed out that serum aldosterone level in patients with heart failure predicts mortality. And aldosterone blockade with an aldosterone antagonist has been shown to improve clinical outcomes in heart failure patients with a depressed left ventricular ejection fraction in RALES, the Randomized Aldactone Evaluation Study (N. Engl. J. Med. 1999;341:709-17) and EPHESUS, the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (N. Engl. J. Med. 2003;348:1309-21). Aldosterone blockade is also actively under study in heart failure patients with preserved systolic function in the ongoing TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) study, due to report results next year.
"There may be certain patient groups that could greatly benefit from vitamin D3 therapy, particularly patients who may not be able to tolerate RAAS blockade or those who have aldosterone escape," she said.
The mechanism by which oral vitamin D3 reduces serum aldosterone is unknown. The mechanism is clearly non–renin-dependent, given that serum renin level remained unchanged. In vitro studies suggest that vitamin D might act through a direct effect on steroidogenesis in adrenal cortical cells, Dr. Boxer said.
The study was funded by the American Heart Association. Dr. Boxer reported having no relevant financial conflicts.
LOS ANGELES – Oral vitamin D3 may have a future as adjunctive therapy in patients with heart failure, according to Dr. Rebecca S. Boxer.
Six months of oral vitamin D3 therapy at 50,000 IU/wk resulted in a 37% decrease in serum aldosterone level in a randomized, double-blind, placebo-controlled trial conducted in vitamin D–deficient patients with heart failure.
Moreover, parathyroid hormone levels, which were elevated at baseline, fell by 41% in the active treatment arm, she reported at the annual scientific sessions of the American Heart Association.
The study involved 64 patients with New York Heart Association class II-IV heart failure, all having a baseline serum vitamin D level below 20 ng/mL. All participants were on maximum tolerated doses of standard heart failure medications. The patients were randomized to oral vitamin D3 at 50,000 IU/wk plus 400 mg of calcium citrate twice daily for 6 months or to calcium plus placebo.
Mean serum vitamin D levels climbed from 19 ng/mL to 60 ng/mL in treated patients while remaining unchanged over time in controls.
Serum aldosterone levels fell from 10.0 ng/mL to 6.3 ng/dL in the active treatment group and remained static in controls. The mean serum parathyroid hormone level dropped from 62.3 pg/mL to 37.1 pg/mL with vitamin D therapy but stayed steady in controls, said Dr. Boxer of Case Western Reserve University, Cleveland.
The primary endpoint in this randomized trial was change in aerobic capacity; vitamin D supplementation had no effect on this endpoint. Nor did it have any significant impact on heart failure symptoms, echocardiographic findings, body weight, blood pressure, serum renin, or C-reactive protein levels in this relatively small study.
Nonetheless, the finding of a moderate reduction in serum aldosterone level indicates that the effects of vitamin D3 on the renin-angiotensin-aldosterone system (RAAS) in patients with heart failure warrants further study, including assessment of possible long-term clinical benefit.
Dr. Boxer pointed out that serum aldosterone level in patients with heart failure predicts mortality. And aldosterone blockade with an aldosterone antagonist has been shown to improve clinical outcomes in heart failure patients with a depressed left ventricular ejection fraction in RALES, the Randomized Aldactone Evaluation Study (N. Engl. J. Med. 1999;341:709-17) and EPHESUS, the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (N. Engl. J. Med. 2003;348:1309-21). Aldosterone blockade is also actively under study in heart failure patients with preserved systolic function in the ongoing TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) study, due to report results next year.
"There may be certain patient groups that could greatly benefit from vitamin D3 therapy, particularly patients who may not be able to tolerate RAAS blockade or those who have aldosterone escape," she said.
The mechanism by which oral vitamin D3 reduces serum aldosterone is unknown. The mechanism is clearly non–renin-dependent, given that serum renin level remained unchanged. In vitro studies suggest that vitamin D might act through a direct effect on steroidogenesis in adrenal cortical cells, Dr. Boxer said.
The study was funded by the American Heart Association. Dr. Boxer reported having no relevant financial conflicts.
LOS ANGELES – Oral vitamin D3 may have a future as adjunctive therapy in patients with heart failure, according to Dr. Rebecca S. Boxer.
Six months of oral vitamin D3 therapy at 50,000 IU/wk resulted in a 37% decrease in serum aldosterone level in a randomized, double-blind, placebo-controlled trial conducted in vitamin D–deficient patients with heart failure.
Moreover, parathyroid hormone levels, which were elevated at baseline, fell by 41% in the active treatment arm, she reported at the annual scientific sessions of the American Heart Association.
The study involved 64 patients with New York Heart Association class II-IV heart failure, all having a baseline serum vitamin D level below 20 ng/mL. All participants were on maximum tolerated doses of standard heart failure medications. The patients were randomized to oral vitamin D3 at 50,000 IU/wk plus 400 mg of calcium citrate twice daily for 6 months or to calcium plus placebo.
Mean serum vitamin D levels climbed from 19 ng/mL to 60 ng/mL in treated patients while remaining unchanged over time in controls.
Serum aldosterone levels fell from 10.0 ng/mL to 6.3 ng/dL in the active treatment group and remained static in controls. The mean serum parathyroid hormone level dropped from 62.3 pg/mL to 37.1 pg/mL with vitamin D therapy but stayed steady in controls, said Dr. Boxer of Case Western Reserve University, Cleveland.
The primary endpoint in this randomized trial was change in aerobic capacity; vitamin D supplementation had no effect on this endpoint. Nor did it have any significant impact on heart failure symptoms, echocardiographic findings, body weight, blood pressure, serum renin, or C-reactive protein levels in this relatively small study.
Nonetheless, the finding of a moderate reduction in serum aldosterone level indicates that the effects of vitamin D3 on the renin-angiotensin-aldosterone system (RAAS) in patients with heart failure warrants further study, including assessment of possible long-term clinical benefit.
Dr. Boxer pointed out that serum aldosterone level in patients with heart failure predicts mortality. And aldosterone blockade with an aldosterone antagonist has been shown to improve clinical outcomes in heart failure patients with a depressed left ventricular ejection fraction in RALES, the Randomized Aldactone Evaluation Study (N. Engl. J. Med. 1999;341:709-17) and EPHESUS, the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (N. Engl. J. Med. 2003;348:1309-21). Aldosterone blockade is also actively under study in heart failure patients with preserved systolic function in the ongoing TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) study, due to report results next year.
"There may be certain patient groups that could greatly benefit from vitamin D3 therapy, particularly patients who may not be able to tolerate RAAS blockade or those who have aldosterone escape," she said.
The mechanism by which oral vitamin D3 reduces serum aldosterone is unknown. The mechanism is clearly non–renin-dependent, given that serum renin level remained unchanged. In vitro studies suggest that vitamin D might act through a direct effect on steroidogenesis in adrenal cortical cells, Dr. Boxer said.
The study was funded by the American Heart Association. Dr. Boxer reported having no relevant financial conflicts.
AT THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN HEART ASSOCIATION
Major Finding: Six months of oral vitamin D3 at 50,000 IU/wk resulted in a 37% reduction in serum aldosterone and a 41% decrease in baseline elevated parathyroid hormone levels in heart failure patients with low serum vitamin D levels.
Data Source: A randomized, double-blind trial of 64 vitamin D–deficient heart failure patients.
Disclosures: The study was funded primarily by the American Heart Association. The presenter reported having no relevant financial conflicts.
Hospital readmissions under attack
Readmissions after hospital discharge for acute myocardial infarction, heart failure, and pneumonia have now become major targets for proposed Medicare savings as part of the current budget tightening in Washington. Hospitals in the past have viewed readmissions either with disdain and disinterest or as a "cash cow."
Readmissions have been good business, as long as Medicare reimbursed hospitals for individual admissions no matter how long or short or how frequent. Readmissions are estimated to cost $17 billion annually. As Medicare costs continue to increase, the control of readmissions appears to be a good target for saving some money. As a result, Medicare levied a maximum reduction of 1% on payments last year on 307 of the nation’s hospitals that were deemed to have too many readmissions (New York Times, Nov. 26, 2012).
Readmissions for AMI and heart failure are among the most frequent hospital admissions and readmissions. Readmissions in cardiology have been an important outcome measure in clinical trials for the last half century. As mortality rates decreased over the years, rehospitalization became more important as clinicians realized its importance in the composite outcome measure of cost and benefit of new therapies. Two of the potential causes of readmission have been early discharge and the lack of postdischarge medical support. The urgency for early discharge for both heart failure and AMI has been driven largely by the misplaced emphasis on shorter hospital stays.
A recent international trial examined readmission rates as an outcome measure in patients who were treated with a percutaneous coronary intervention after an ST-elevation MI. According to that study, the readmission rate in the United States is almost twice that of European centers. Much of this increase was related to a shorter hospital stay in the United States that was half that of the European centers: 8 vs. 3 days (JAMA 2012;307:66-74).
In the last few years there has actually been a speed contest in some cardiology quarters to see how quickly patients can be discharged after a STEMI. As a result, a "drive through" mentality for percutaneous coronary intervention and AMI treatment has developed. Some of this has been generated by hospital administration, but with full participation by cardiologists. There appears to be little or no benefit to the short stay other than on the hospital bottom line. It now appears that, in the future, the financial benefit of this expedited care will be challenged.
Heart failure admissions suffer from similar expedited care. The duration of a hospital stay for heart failure decreased from 8.8 to 6.3 days between 1996 and 2006. Similar international disparity exists as observed with AMI. The rate of readmission in 30 days after discharge is estimated to be roughly 20%. The occurrence of readmission within 30 days is not just an abstract statistic and an inconvenience to patients but is associated with a mortality in the same period of 6.4%, which exceeded inpatient mortality (JAMA 2010;303;2141-7).
Many patients admitted with fluid overload leave the hospital on the same medication that they were taking prior to admission and at the same weight as at admission. Some of this is the result of undertreatment with diuretics, driven by misconceptions about serum creatinine levels, but in many situations patients may not even be weighed. Heart failure patients are often elderly who have significant concomitant disease and require careful in-hospital modification of heart failure therapy. Many of these elderly patients also require the institution of medical and social support prior to discharge.
Inner-city and referral hospitals indicate that they are being unfairly penalized by the nature of the demographic and severity of their patient mix. Some of this pushback is warranted. The "one size fits all" approach by Medicare may well require some modification in view of the variation in both the medical and social complexity. Some form of staging of severity and the need for outpatient nurse support needs to be considered.
Hospitals, nevertheless, are scrambling to respond to the Medicare threat and have begun to apply resources and innovation to solve this pressing issue. Cardiologists themselves also can have an important impact on the problem. We all need to slow down and spend some time dealing with the long-term solutions to short-term problems like acute heart failure and AMI.
Dr. Goldstein writes the column, "Heart of the Matter," which appears regularly in Cardiology News, a Frontline Medical Communications publication. He is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Readmissions after hospital discharge for acute myocardial infarction, heart failure, and pneumonia have now become major targets for proposed Medicare savings as part of the current budget tightening in Washington. Hospitals in the past have viewed readmissions either with disdain and disinterest or as a "cash cow."
Readmissions have been good business, as long as Medicare reimbursed hospitals for individual admissions no matter how long or short or how frequent. Readmissions are estimated to cost $17 billion annually. As Medicare costs continue to increase, the control of readmissions appears to be a good target for saving some money. As a result, Medicare levied a maximum reduction of 1% on payments last year on 307 of the nation’s hospitals that were deemed to have too many readmissions (New York Times, Nov. 26, 2012).
Readmissions for AMI and heart failure are among the most frequent hospital admissions and readmissions. Readmissions in cardiology have been an important outcome measure in clinical trials for the last half century. As mortality rates decreased over the years, rehospitalization became more important as clinicians realized its importance in the composite outcome measure of cost and benefit of new therapies. Two of the potential causes of readmission have been early discharge and the lack of postdischarge medical support. The urgency for early discharge for both heart failure and AMI has been driven largely by the misplaced emphasis on shorter hospital stays.
A recent international trial examined readmission rates as an outcome measure in patients who were treated with a percutaneous coronary intervention after an ST-elevation MI. According to that study, the readmission rate in the United States is almost twice that of European centers. Much of this increase was related to a shorter hospital stay in the United States that was half that of the European centers: 8 vs. 3 days (JAMA 2012;307:66-74).
In the last few years there has actually been a speed contest in some cardiology quarters to see how quickly patients can be discharged after a STEMI. As a result, a "drive through" mentality for percutaneous coronary intervention and AMI treatment has developed. Some of this has been generated by hospital administration, but with full participation by cardiologists. There appears to be little or no benefit to the short stay other than on the hospital bottom line. It now appears that, in the future, the financial benefit of this expedited care will be challenged.
Heart failure admissions suffer from similar expedited care. The duration of a hospital stay for heart failure decreased from 8.8 to 6.3 days between 1996 and 2006. Similar international disparity exists as observed with AMI. The rate of readmission in 30 days after discharge is estimated to be roughly 20%. The occurrence of readmission within 30 days is not just an abstract statistic and an inconvenience to patients but is associated with a mortality in the same period of 6.4%, which exceeded inpatient mortality (JAMA 2010;303;2141-7).
Many patients admitted with fluid overload leave the hospital on the same medication that they were taking prior to admission and at the same weight as at admission. Some of this is the result of undertreatment with diuretics, driven by misconceptions about serum creatinine levels, but in many situations patients may not even be weighed. Heart failure patients are often elderly who have significant concomitant disease and require careful in-hospital modification of heart failure therapy. Many of these elderly patients also require the institution of medical and social support prior to discharge.
Inner-city and referral hospitals indicate that they are being unfairly penalized by the nature of the demographic and severity of their patient mix. Some of this pushback is warranted. The "one size fits all" approach by Medicare may well require some modification in view of the variation in both the medical and social complexity. Some form of staging of severity and the need for outpatient nurse support needs to be considered.
Hospitals, nevertheless, are scrambling to respond to the Medicare threat and have begun to apply resources and innovation to solve this pressing issue. Cardiologists themselves also can have an important impact on the problem. We all need to slow down and spend some time dealing with the long-term solutions to short-term problems like acute heart failure and AMI.
Dr. Goldstein writes the column, "Heart of the Matter," which appears regularly in Cardiology News, a Frontline Medical Communications publication. He is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Readmissions after hospital discharge for acute myocardial infarction, heart failure, and pneumonia have now become major targets for proposed Medicare savings as part of the current budget tightening in Washington. Hospitals in the past have viewed readmissions either with disdain and disinterest or as a "cash cow."
Readmissions have been good business, as long as Medicare reimbursed hospitals for individual admissions no matter how long or short or how frequent. Readmissions are estimated to cost $17 billion annually. As Medicare costs continue to increase, the control of readmissions appears to be a good target for saving some money. As a result, Medicare levied a maximum reduction of 1% on payments last year on 307 of the nation’s hospitals that were deemed to have too many readmissions (New York Times, Nov. 26, 2012).
Readmissions for AMI and heart failure are among the most frequent hospital admissions and readmissions. Readmissions in cardiology have been an important outcome measure in clinical trials for the last half century. As mortality rates decreased over the years, rehospitalization became more important as clinicians realized its importance in the composite outcome measure of cost and benefit of new therapies. Two of the potential causes of readmission have been early discharge and the lack of postdischarge medical support. The urgency for early discharge for both heart failure and AMI has been driven largely by the misplaced emphasis on shorter hospital stays.
A recent international trial examined readmission rates as an outcome measure in patients who were treated with a percutaneous coronary intervention after an ST-elevation MI. According to that study, the readmission rate in the United States is almost twice that of European centers. Much of this increase was related to a shorter hospital stay in the United States that was half that of the European centers: 8 vs. 3 days (JAMA 2012;307:66-74).
In the last few years there has actually been a speed contest in some cardiology quarters to see how quickly patients can be discharged after a STEMI. As a result, a "drive through" mentality for percutaneous coronary intervention and AMI treatment has developed. Some of this has been generated by hospital administration, but with full participation by cardiologists. There appears to be little or no benefit to the short stay other than on the hospital bottom line. It now appears that, in the future, the financial benefit of this expedited care will be challenged.
Heart failure admissions suffer from similar expedited care. The duration of a hospital stay for heart failure decreased from 8.8 to 6.3 days between 1996 and 2006. Similar international disparity exists as observed with AMI. The rate of readmission in 30 days after discharge is estimated to be roughly 20%. The occurrence of readmission within 30 days is not just an abstract statistic and an inconvenience to patients but is associated with a mortality in the same period of 6.4%, which exceeded inpatient mortality (JAMA 2010;303;2141-7).
Many patients admitted with fluid overload leave the hospital on the same medication that they were taking prior to admission and at the same weight as at admission. Some of this is the result of undertreatment with diuretics, driven by misconceptions about serum creatinine levels, but in many situations patients may not even be weighed. Heart failure patients are often elderly who have significant concomitant disease and require careful in-hospital modification of heart failure therapy. Many of these elderly patients also require the institution of medical and social support prior to discharge.
Inner-city and referral hospitals indicate that they are being unfairly penalized by the nature of the demographic and severity of their patient mix. Some of this pushback is warranted. The "one size fits all" approach by Medicare may well require some modification in view of the variation in both the medical and social complexity. Some form of staging of severity and the need for outpatient nurse support needs to be considered.
Hospitals, nevertheless, are scrambling to respond to the Medicare threat and have begun to apply resources and innovation to solve this pressing issue. Cardiologists themselves also can have an important impact on the problem. We all need to slow down and spend some time dealing with the long-term solutions to short-term problems like acute heart failure and AMI.
Dr. Goldstein writes the column, "Heart of the Matter," which appears regularly in Cardiology News, a Frontline Medical Communications publication. He is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Metabolic bone disease markers poor in CKD patients with HF
SAN DIEGO – Levels of calcium, phosphorus, and parathyroid hormone are poorer in patients with heart failure at each stage of chronic kidney disease, results from a large study showed.
The finding "raises more questions than it answers," Dr. Claudine T. Jurkovitz said in an interview during a poster session at Kidney Week 2012. "The question is, are these patients less well managed for their metabolic bone disease than the patients without HF? If so, why? Is it because their HF is so severe, or is it because the nephrologists count on cardiologists or primary care physicians to treat the patients’ metabolic bone disease also? And do cardiologists identify metabolic bone disease in patients with HF?"
Dr. Jurkovitz, a physician scientist with Christiana Care Health System in Newark, Del., and her associates compared the management of CKD-associated metabolic bone disease between patients with and without HF who were treated at a local nephrology practice between 2000 and 2010. They evaluated the medical records of 11,883 patients with CKD stage 3 and above, and excluded dialysis and transplant patients. The researchers calculated average calcium, phosphorus, and intact parathyroid hormone (iPTH) by radioimmunoassay for each patient, and used multilinear regressions to determine the effects of CKD and HF on calcium, phosphorus, and iPTH after controlling for age, race, and gender.
The mean follow-up of the 11,883 patients was 4 years. Of these, nearly one-quarter (24%) had HF at baseline, while 76% had stage 3 CKD, 22% had stage 4 CKD, and 2% had stage 5 CKD. Patients with HF were slightly older, with a mean of 69 years, than were their counterparts without HF, who had a mean 66 years.
Dr. Jurkovitz and her associates found that the adjusted mean for calcium was significantly lower in patients with HF at each CKD stage. The interaction between CKD and HF was statistically significant. The adjusted means for phosphorus and iPTH were significantly higher in patients with HF at each CKD stage, while the interactions between CKD and HF were not significant.
"Physicians need to be concerned about the management of chronic kidney disease in their patients with HF, and the management of metabolic bone disease addressed on a case by case basis in a dialogue between the cardiologists, nephrologists, and primary care physicians," she concluded.
The meeting was sponsored by the American Society of Nephrology. Dr. Jurkovitz said that she had no relevant financial conflicts to disclose.
SAN DIEGO – Levels of calcium, phosphorus, and parathyroid hormone are poorer in patients with heart failure at each stage of chronic kidney disease, results from a large study showed.
The finding "raises more questions than it answers," Dr. Claudine T. Jurkovitz said in an interview during a poster session at Kidney Week 2012. "The question is, are these patients less well managed for their metabolic bone disease than the patients without HF? If so, why? Is it because their HF is so severe, or is it because the nephrologists count on cardiologists or primary care physicians to treat the patients’ metabolic bone disease also? And do cardiologists identify metabolic bone disease in patients with HF?"
Dr. Jurkovitz, a physician scientist with Christiana Care Health System in Newark, Del., and her associates compared the management of CKD-associated metabolic bone disease between patients with and without HF who were treated at a local nephrology practice between 2000 and 2010. They evaluated the medical records of 11,883 patients with CKD stage 3 and above, and excluded dialysis and transplant patients. The researchers calculated average calcium, phosphorus, and intact parathyroid hormone (iPTH) by radioimmunoassay for each patient, and used multilinear regressions to determine the effects of CKD and HF on calcium, phosphorus, and iPTH after controlling for age, race, and gender.
The mean follow-up of the 11,883 patients was 4 years. Of these, nearly one-quarter (24%) had HF at baseline, while 76% had stage 3 CKD, 22% had stage 4 CKD, and 2% had stage 5 CKD. Patients with HF were slightly older, with a mean of 69 years, than were their counterparts without HF, who had a mean 66 years.
Dr. Jurkovitz and her associates found that the adjusted mean for calcium was significantly lower in patients with HF at each CKD stage. The interaction between CKD and HF was statistically significant. The adjusted means for phosphorus and iPTH were significantly higher in patients with HF at each CKD stage, while the interactions between CKD and HF were not significant.
"Physicians need to be concerned about the management of chronic kidney disease in their patients with HF, and the management of metabolic bone disease addressed on a case by case basis in a dialogue between the cardiologists, nephrologists, and primary care physicians," she concluded.
The meeting was sponsored by the American Society of Nephrology. Dr. Jurkovitz said that she had no relevant financial conflicts to disclose.
SAN DIEGO – Levels of calcium, phosphorus, and parathyroid hormone are poorer in patients with heart failure at each stage of chronic kidney disease, results from a large study showed.
The finding "raises more questions than it answers," Dr. Claudine T. Jurkovitz said in an interview during a poster session at Kidney Week 2012. "The question is, are these patients less well managed for their metabolic bone disease than the patients without HF? If so, why? Is it because their HF is so severe, or is it because the nephrologists count on cardiologists or primary care physicians to treat the patients’ metabolic bone disease also? And do cardiologists identify metabolic bone disease in patients with HF?"
Dr. Jurkovitz, a physician scientist with Christiana Care Health System in Newark, Del., and her associates compared the management of CKD-associated metabolic bone disease between patients with and without HF who were treated at a local nephrology practice between 2000 and 2010. They evaluated the medical records of 11,883 patients with CKD stage 3 and above, and excluded dialysis and transplant patients. The researchers calculated average calcium, phosphorus, and intact parathyroid hormone (iPTH) by radioimmunoassay for each patient, and used multilinear regressions to determine the effects of CKD and HF on calcium, phosphorus, and iPTH after controlling for age, race, and gender.
The mean follow-up of the 11,883 patients was 4 years. Of these, nearly one-quarter (24%) had HF at baseline, while 76% had stage 3 CKD, 22% had stage 4 CKD, and 2% had stage 5 CKD. Patients with HF were slightly older, with a mean of 69 years, than were their counterparts without HF, who had a mean 66 years.
Dr. Jurkovitz and her associates found that the adjusted mean for calcium was significantly lower in patients with HF at each CKD stage. The interaction between CKD and HF was statistically significant. The adjusted means for phosphorus and iPTH were significantly higher in patients with HF at each CKD stage, while the interactions between CKD and HF were not significant.
"Physicians need to be concerned about the management of chronic kidney disease in their patients with HF, and the management of metabolic bone disease addressed on a case by case basis in a dialogue between the cardiologists, nephrologists, and primary care physicians," she concluded.
The meeting was sponsored by the American Society of Nephrology. Dr. Jurkovitz said that she had no relevant financial conflicts to disclose.
AT KIDNEY WEEK 2012
Major Finding: The adjusted mean for serum calcium was significantly lower in patients with heart failure at each CKD stage, while the adjusted means for serum phosphorus and parathyroid hormone by immunoassay were significantly higher in patients with HF at each CKD stage.
Data Source: This was a study of 11,883 patients with CKD stage 3 and above who were treated at a single nephrology practice during 2000-2010.
Disclosures: The meeting was sponsored by the American Society of Nephrology. Dr. Jurkovitz said that she had no relevant financial conflicts to disclose.
Ultrafiltration Flops for Acute Cardiorenal Syndrome
LOS ANGELES – Mechanical venovenous ultrafiltration proved inferior to drug therapy in diuretic-responsive patients hospitalized with acute decompensated heart failure and cardiorenal syndrome in a major multicenter randomized trial.
In the Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARRESS-HF), weight loss due to elimination of excess fluid was similar at 96 hours in the two treatment arms. However, renal function was significantly worse in the ultrafiltration group at that time point, and it remained so even 60 days from baseline, Dr. Bradley A. Bart reported at the annual scientific sessions of the American Heart Association.
Moreover, the combined rate of the secondary end point comprising death or serious adverse events at 6 months was 72% in the ultrafiltration group, compared with 57% in patients treated with a standardized pharmacologic regimen, for an adjusted 50% increased risk in the ultrafiltration group. Serious adverse events included kidney failure, bleeding complications, and problems due to intravenous catheters.
"Neither group was adequately decongested at the time of hospital discharge. This is a challenging group of patients to treat. The 60-day event rates are very high, and better therapies are needed in the future," said Dr. Bart of the Hennepin County Medical Center, Minneapolis.
Acute cardiorenal syndrome occurs in up to one-third of patients with acute decompensated heart failure. The CARRESS-HF trial randomized 188 affected patients who were diuretic responsive to a stepped pharmacologic care algorithm or to ultrafiltration at a rate of 200 mL/hr using the commercially available Aquadex System 100 device manufactured by CHF Solutions.
Both treatment groups lost about 12 pounds through 96 hours. However, while mean serum creatinine was unchanged from baseline in the drug therapy group, it climbed by 0.25 mg/dL in the ultrafiltration group.
Discussant Dr. Milton Packer agreed with the investigators’ conclusion that the study data offer no support for the use of mechanical ultrafiltration in patients who are responsive to diuretics.
"I still think there’s a role for ultrafiltration in patients who are diuretic unresponsive," added Dr. Packer, professor and chairman of the department of clinical sciences at the University of Texas Southwestern Medical Center, Dallas.
He called CARRESS-HF "a really terrific study and an important one." Ultrafiltration can be programmed to pull fluid off of patients more rapidly than is possible with drug therapy. Had mechanical ultrafiltration performed better than well-managed drug therapy in CARRESS-HF, the message to physicians would have been that they shouldn’t spend much time fiddling with diuretic therapy in such patients, but should instead turn to ultrafiltration much earlier during the hospitalization, even in diuretic-responsive patients.
"What is striking about this study is that the difference in renal function was present not only during the ultrafiltration but afterward. That’s something that, frankly speaking, gives us pause. It may be worthwhile in someone who’s diuretic unresponsive; it’s not worthwhile in someone who is diuretic responsive," according to Dr. Packer.
Simultaneous with Dr. Bart’s presentation of the CARRESS-HF results at the AHA conference, the study findings were published online (N. Engl. J. Med. 2012 [doi:10.1056/NEJMoa1210357]).
In an accompanying editorial, Dr. W.H. Wilson Tang of the Cleveland Clinic called the outcomes in CARRESS-HF "overall dismal," with more than one-third of patients dying or being readmitted for acute decompensated heart failure within 60 days, regardless of their treatment arm. But that’s representative of what happens in everyday clinical practice when acute cardiorenal syndrome occurs (N. Engl. J. Med. 2012 [doi:10.1056/NEJMe1212881]).
It’s unclear why serum creatinine rose further and stayed high in the ultrafiltration-treated patients. Dr. Tang speculated that it might be because the mechanical device drew off fluid so rapidly that kidney perfusion was decreased.
"We may even have to confront the possibility that the pressure to reduce hospital length of stay with a strategy of initial aggressive diuresis in patients with acute decompensated heart failure may actually result in an increased incidence of the acute cardiorenal syndrome and cause unwanted consequences. Perhaps slow and steady may ultimately win the race after all," according to Dr. Tang.
CARRESS-HF was sponsored by the National Heart, Lung, and Blood Institute and carried out by the Heart Failure Clinical Research Network. Dr. Bart, Dr. Packer, and Dr. Tang reported having no relevant financial disclosures.
LOS ANGELES – Mechanical venovenous ultrafiltration proved inferior to drug therapy in diuretic-responsive patients hospitalized with acute decompensated heart failure and cardiorenal syndrome in a major multicenter randomized trial.
In the Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARRESS-HF), weight loss due to elimination of excess fluid was similar at 96 hours in the two treatment arms. However, renal function was significantly worse in the ultrafiltration group at that time point, and it remained so even 60 days from baseline, Dr. Bradley A. Bart reported at the annual scientific sessions of the American Heart Association.
Moreover, the combined rate of the secondary end point comprising death or serious adverse events at 6 months was 72% in the ultrafiltration group, compared with 57% in patients treated with a standardized pharmacologic regimen, for an adjusted 50% increased risk in the ultrafiltration group. Serious adverse events included kidney failure, bleeding complications, and problems due to intravenous catheters.
"Neither group was adequately decongested at the time of hospital discharge. This is a challenging group of patients to treat. The 60-day event rates are very high, and better therapies are needed in the future," said Dr. Bart of the Hennepin County Medical Center, Minneapolis.
Acute cardiorenal syndrome occurs in up to one-third of patients with acute decompensated heart failure. The CARRESS-HF trial randomized 188 affected patients who were diuretic responsive to a stepped pharmacologic care algorithm or to ultrafiltration at a rate of 200 mL/hr using the commercially available Aquadex System 100 device manufactured by CHF Solutions.
Both treatment groups lost about 12 pounds through 96 hours. However, while mean serum creatinine was unchanged from baseline in the drug therapy group, it climbed by 0.25 mg/dL in the ultrafiltration group.
Discussant Dr. Milton Packer agreed with the investigators’ conclusion that the study data offer no support for the use of mechanical ultrafiltration in patients who are responsive to diuretics.
"I still think there’s a role for ultrafiltration in patients who are diuretic unresponsive," added Dr. Packer, professor and chairman of the department of clinical sciences at the University of Texas Southwestern Medical Center, Dallas.
He called CARRESS-HF "a really terrific study and an important one." Ultrafiltration can be programmed to pull fluid off of patients more rapidly than is possible with drug therapy. Had mechanical ultrafiltration performed better than well-managed drug therapy in CARRESS-HF, the message to physicians would have been that they shouldn’t spend much time fiddling with diuretic therapy in such patients, but should instead turn to ultrafiltration much earlier during the hospitalization, even in diuretic-responsive patients.
"What is striking about this study is that the difference in renal function was present not only during the ultrafiltration but afterward. That’s something that, frankly speaking, gives us pause. It may be worthwhile in someone who’s diuretic unresponsive; it’s not worthwhile in someone who is diuretic responsive," according to Dr. Packer.
Simultaneous with Dr. Bart’s presentation of the CARRESS-HF results at the AHA conference, the study findings were published online (N. Engl. J. Med. 2012 [doi:10.1056/NEJMoa1210357]).
In an accompanying editorial, Dr. W.H. Wilson Tang of the Cleveland Clinic called the outcomes in CARRESS-HF "overall dismal," with more than one-third of patients dying or being readmitted for acute decompensated heart failure within 60 days, regardless of their treatment arm. But that’s representative of what happens in everyday clinical practice when acute cardiorenal syndrome occurs (N. Engl. J. Med. 2012 [doi:10.1056/NEJMe1212881]).
It’s unclear why serum creatinine rose further and stayed high in the ultrafiltration-treated patients. Dr. Tang speculated that it might be because the mechanical device drew off fluid so rapidly that kidney perfusion was decreased.
"We may even have to confront the possibility that the pressure to reduce hospital length of stay with a strategy of initial aggressive diuresis in patients with acute decompensated heart failure may actually result in an increased incidence of the acute cardiorenal syndrome and cause unwanted consequences. Perhaps slow and steady may ultimately win the race after all," according to Dr. Tang.
CARRESS-HF was sponsored by the National Heart, Lung, and Blood Institute and carried out by the Heart Failure Clinical Research Network. Dr. Bart, Dr. Packer, and Dr. Tang reported having no relevant financial disclosures.
LOS ANGELES – Mechanical venovenous ultrafiltration proved inferior to drug therapy in diuretic-responsive patients hospitalized with acute decompensated heart failure and cardiorenal syndrome in a major multicenter randomized trial.
In the Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARRESS-HF), weight loss due to elimination of excess fluid was similar at 96 hours in the two treatment arms. However, renal function was significantly worse in the ultrafiltration group at that time point, and it remained so even 60 days from baseline, Dr. Bradley A. Bart reported at the annual scientific sessions of the American Heart Association.
Moreover, the combined rate of the secondary end point comprising death or serious adverse events at 6 months was 72% in the ultrafiltration group, compared with 57% in patients treated with a standardized pharmacologic regimen, for an adjusted 50% increased risk in the ultrafiltration group. Serious adverse events included kidney failure, bleeding complications, and problems due to intravenous catheters.
"Neither group was adequately decongested at the time of hospital discharge. This is a challenging group of patients to treat. The 60-day event rates are very high, and better therapies are needed in the future," said Dr. Bart of the Hennepin County Medical Center, Minneapolis.
Acute cardiorenal syndrome occurs in up to one-third of patients with acute decompensated heart failure. The CARRESS-HF trial randomized 188 affected patients who were diuretic responsive to a stepped pharmacologic care algorithm or to ultrafiltration at a rate of 200 mL/hr using the commercially available Aquadex System 100 device manufactured by CHF Solutions.
Both treatment groups lost about 12 pounds through 96 hours. However, while mean serum creatinine was unchanged from baseline in the drug therapy group, it climbed by 0.25 mg/dL in the ultrafiltration group.
Discussant Dr. Milton Packer agreed with the investigators’ conclusion that the study data offer no support for the use of mechanical ultrafiltration in patients who are responsive to diuretics.
"I still think there’s a role for ultrafiltration in patients who are diuretic unresponsive," added Dr. Packer, professor and chairman of the department of clinical sciences at the University of Texas Southwestern Medical Center, Dallas.
He called CARRESS-HF "a really terrific study and an important one." Ultrafiltration can be programmed to pull fluid off of patients more rapidly than is possible with drug therapy. Had mechanical ultrafiltration performed better than well-managed drug therapy in CARRESS-HF, the message to physicians would have been that they shouldn’t spend much time fiddling with diuretic therapy in such patients, but should instead turn to ultrafiltration much earlier during the hospitalization, even in diuretic-responsive patients.
"What is striking about this study is that the difference in renal function was present not only during the ultrafiltration but afterward. That’s something that, frankly speaking, gives us pause. It may be worthwhile in someone who’s diuretic unresponsive; it’s not worthwhile in someone who is diuretic responsive," according to Dr. Packer.
Simultaneous with Dr. Bart’s presentation of the CARRESS-HF results at the AHA conference, the study findings were published online (N. Engl. J. Med. 2012 [doi:10.1056/NEJMoa1210357]).
In an accompanying editorial, Dr. W.H. Wilson Tang of the Cleveland Clinic called the outcomes in CARRESS-HF "overall dismal," with more than one-third of patients dying or being readmitted for acute decompensated heart failure within 60 days, regardless of their treatment arm. But that’s representative of what happens in everyday clinical practice when acute cardiorenal syndrome occurs (N. Engl. J. Med. 2012 [doi:10.1056/NEJMe1212881]).
It’s unclear why serum creatinine rose further and stayed high in the ultrafiltration-treated patients. Dr. Tang speculated that it might be because the mechanical device drew off fluid so rapidly that kidney perfusion was decreased.
"We may even have to confront the possibility that the pressure to reduce hospital length of stay with a strategy of initial aggressive diuresis in patients with acute decompensated heart failure may actually result in an increased incidence of the acute cardiorenal syndrome and cause unwanted consequences. Perhaps slow and steady may ultimately win the race after all," according to Dr. Tang.
CARRESS-HF was sponsored by the National Heart, Lung, and Blood Institute and carried out by the Heart Failure Clinical Research Network. Dr. Bart, Dr. Packer, and Dr. Tang reported having no relevant financial disclosures.
AT THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN HEART ASSOCIATION
Major Finding: Short- and longer-term outcomes were significantly worse in diuretic-responsive patients with acute decompensated heart failure and acute cardiorenal syndrome who were randomized to ultrafiltration for diuresis than in those treated pharmacologically.
Data Source: Data are from a randomized, prospective multicenter trial carried out by the Heart Failure Clinical Research Network. It included 188 patients hospitalized for acute decompensated heart failure, all diuretic responsive and all with acute cardiorenal syndrome.
Disclosures: The CARRESS-HF trial was sponsored by the National Heart, Lung, and Blood Institute. Dr. Bart, Dr. Packer, and Dr. Tang reported having no relevant financial disclosures.
ICDs' Role Remains Uncertain in CKD Patients
LOS ANGELES – Patients with advanced chronic kidney disease who receive an implantable cardioverter defibrillator are not like other patients who receive these devices.
But results from a trio of studies reported at the meeting show how hard it is for researchers to get a clear handle on what makes chronic kidney disease patients different, whether they have different outcomes than defibrillator recipients without CKD, and what is the best approach for judiciously using implantable cardioverter defibrillators (ICDs) in patients with renal dysfunction.
It’s a particularly relevant question because CKD is linked with a substantially increased risk for sudden cardiac death (patients on dialysis have about a fivefold higher risk for sudden cardiac death, compared with patients with normal or mildly impaired renal function), but patients with CKD were excluded from the major trials that proved the efficacy of ICDs for preventing sudden cardiac death. The lack of data from randomized, prospective trials leaves questions about the efficacy, and perhaps as importantly, the cost efficiency of ICDs in CKD patients.
"Should patients with CKD get ICDs? I don’t know the answer, but I don’t think that, categorically, patients with CKD should be excluded from ICD treatment," commented Dr. Matthew Reynolds, a cardiac electrophysiologist and director of the Economics and Quality of Life Research Center at Harvard Medical School in Boston. But many patients with CKD, especially advanced disease, are not good ICD candidates.
"For a lot of patients with CKD, someone decides not to place an ICD. Those patients are not represented" in studies that focus on ICD recipients, said Dr. Reynolds, who cochaired the session where the three studies were presented.
"For every CKD patients who gets an ICD, an electrophysiologist has made a decision that this was a CKD patient who could benefit. It’s hard to extrapolate from that" to all CKD patients, agreed Dr. Paul Varosy, director of electrophysiology at the Denver Veterans Administration Medical Center. "Patients with CKD who get ICDs are fundamentally different patients."
The aim of one of the studies reported was to assess ICD efficacy in CKD patients by comparing survival between patients with ICDs divided into stage III CKD (an estimated glomerular filtration rate [GFR] of 30-59 mL/min per 1.73 m2), stage IV or V (a GFR of less than mL/min per 1.73 m2), or no CKD. The study examined 3-year follow-up data from 556 patients who received an ICD or similar device during 2006-2010 at the Minneapolis Veterans Administration Medical Center at the University of Minnesota. The series included 301 patients with no CKD, 230 with stage III CKD, and 25 patients with more severe CKD.
The analysis showed a similar incidence of appropriate and inappropriate shocks from the ICDs in all three groups, and roughly similar efficacy of the ICDs for preventing sudden cardiac death, Dr. Selcuk Adabag said at the Annual Scientific Sessions of the American Heart Association. But mortality rates rose substantially higher as renal function worsened, rising from 17% in patients without CKD to 30% in those with stage III disease, and to 56% in those with stage IV or V disease, reported Dr. Adabag, a cardiac electrophysiologist at the University of Minnesota in Minneapolis.
The mortality differences were hardly surprising, and they likely have little direct relationship to the ICDs. "In patients with CKD, the worse the disease, the worse their prognosis. CKD is a complex disease with a whole range of [mortality] risk factors; preventable sudden cardiac death is just one" of the risks these patients face, Dr. Varosy said in an interview.
Selection bias makes the ICD observations questionable, Dr. Reynolds said. "I’m very concerned about concluding that ICDs have similar effectiveness in patients with stage IV or V CKD, compared with no CKD. The study had only 25 patients with stage IV or V disease. I have to think that there was some belief that these were good candidates and that there were a lot of other patients with severe CKD where a physician decided not to implant an ICD. Those patients are not represented in the data," Dr. Reynolds said.
Another study ran a pair of meta-analyses to explore the interactions of ICDs and CKD. In both analyses, CKD was defined as patients on dialysis, those with a creatinine clearance of less than 60 mL/kg per 1.73 m2, or patients with a serum creatinine of at least 1.5 mg/dL.
The first analysis looked at the impact of ICDs on all-cause death among CKD patients at high risk for sudden cardiac death. The literature search found five reports that addressed this issue, in a total of 17,460 patients, which showed that ICD placement linked with a statistically significant 35% cut in total mortality, compared with similar, propensity-score matched patients who did not get ICDs, Dr. Nader Makki said at the meeting.
The second analysis involved 15 reports with 5,333 patients, and used multivariate adjustment to find that patients who had received an ICD and also had CKD had a statistically significant, 2.9-fold higher mortality rate than did ICD recipients without CKD, highlighting the high risk for nonarrhythmic death that CKD patients face, said Dr. Makki, a researcher at the University of Iowa in Iowa City. "Despite a paucity of randomized trials in the CKD population, these data support use of ICDs for the prevention of sudden cardiac death in patients at risk," he said. "We believe that ICDs are underused in this population," patients with CKD.
But these analyses are compromised by the data they used, said Dr. Reynolds. The data were "heavily weighted with a couple of large studies that used claims data. My concern is the potential for confounding by indication. Patients who get ICDs are somehow not as sick as those who don’t."
The third study looked at the impact of CKD on the aftermath of ICD replacement among the 1,744 patients enrolled in the REPLACE (Implantable Cardiac Pulse Generator Replacement Registry) trial, which tracked the incidence of complications following replacement of ICD generators and leads. Among the enrolled patients, researchers had renal-function data for 1,662 patients. About 80% had either mild or moderate renal dysfunction, while 6% had an estimated GFR less than 30 mL/min per 1.73 m2, and the remained had normal renal function.
The incidence of complications was 15% overall, and the analysis showed roughly this rate across all strata of CKD severity. Even among patients with severe CKD, the complication rate was about 20%, and not significantly different from patients with even normal renal function, Dr. Suneet Mittal reported at the meeting. The split between major and minor complications also varied little by renal function, and the incidence of infections was 1%-2% across all five levels of renal function examined.
But CKD severity played a big role in 6-month mortality. A multivariate analysis showed that CKD stage played a significant role in survival; for each stage of worsened renal function the risk of death rose by 50%. (Other significant predictors were recent heart-failure hospitalization, severe heart failure, treatment with an antiarrhythmic drug, and history of cerebrovascular disease.) In actual numbers, the 6-month mortality rate was 2% among patients with either none or mild renal dysfunction that jumped to a 9% rate in patients with an estimated GFR of 15-29 mL/min per 1.73 m2, and to 16% in those on dialysis, said Dr. Mittal, a cardiac electrophysiologist at Columbia University in New York. The analyses also showed that the increased mortality risk linked to severe CKD became apparent by a month after ICD replacement, and it was not driven by procedure-related complications.
"Why do these patients [with severe CKD] do so much worse? We thought that if we looked at all their complications we’d pick up the reason, but clearly there are things that we have not yet recognized," Dr. Mittal said. "There are a lot of things that we didn’t capture in the study."
Although the analysis shed little light on what was behind the high mortality risk in severe CKD patients, it effectively highlighted how risky ICD replacements are in any patient.
"The incidence of complications, 15%-23%, was striking. It’s substantially greater than what’s been seen in any registry-based data or administrative-based data," said Dr. Varosy. He cited the unique ability of this registry to capture all the minor complications following ICD replacement.
"These are frightening numbers [because] we tell patients that there is a very small risk" from ICD replacement procedures, commented Dr. Kalyanam Shivkumar, professor and director of the University of California Los Angeles Cardiac Arrhythmia Center.
Dr. Reynolds said that he has been a consultant to Medtronic and Biosense Webster and has received research grants from Edwards Lifesciences. Dr. Varosy had no disclosures. Dr. Adabag said that he had received research grants from Medtronic and Boston Scientific. Dr. Makki had no disclosures. The REPLACE registry was sponsored by Biotronik and Dr. Mittal said that has been a consultant to Biotronik. Dr. Shivkumar had no disclosures.
LOS ANGELES – Patients with advanced chronic kidney disease who receive an implantable cardioverter defibrillator are not like other patients who receive these devices.
But results from a trio of studies reported at the meeting show how hard it is for researchers to get a clear handle on what makes chronic kidney disease patients different, whether they have different outcomes than defibrillator recipients without CKD, and what is the best approach for judiciously using implantable cardioverter defibrillators (ICDs) in patients with renal dysfunction.
It’s a particularly relevant question because CKD is linked with a substantially increased risk for sudden cardiac death (patients on dialysis have about a fivefold higher risk for sudden cardiac death, compared with patients with normal or mildly impaired renal function), but patients with CKD were excluded from the major trials that proved the efficacy of ICDs for preventing sudden cardiac death. The lack of data from randomized, prospective trials leaves questions about the efficacy, and perhaps as importantly, the cost efficiency of ICDs in CKD patients.
"Should patients with CKD get ICDs? I don’t know the answer, but I don’t think that, categorically, patients with CKD should be excluded from ICD treatment," commented Dr. Matthew Reynolds, a cardiac electrophysiologist and director of the Economics and Quality of Life Research Center at Harvard Medical School in Boston. But many patients with CKD, especially advanced disease, are not good ICD candidates.
"For a lot of patients with CKD, someone decides not to place an ICD. Those patients are not represented" in studies that focus on ICD recipients, said Dr. Reynolds, who cochaired the session where the three studies were presented.
"For every CKD patients who gets an ICD, an electrophysiologist has made a decision that this was a CKD patient who could benefit. It’s hard to extrapolate from that" to all CKD patients, agreed Dr. Paul Varosy, director of electrophysiology at the Denver Veterans Administration Medical Center. "Patients with CKD who get ICDs are fundamentally different patients."
The aim of one of the studies reported was to assess ICD efficacy in CKD patients by comparing survival between patients with ICDs divided into stage III CKD (an estimated glomerular filtration rate [GFR] of 30-59 mL/min per 1.73 m2), stage IV or V (a GFR of less than mL/min per 1.73 m2), or no CKD. The study examined 3-year follow-up data from 556 patients who received an ICD or similar device during 2006-2010 at the Minneapolis Veterans Administration Medical Center at the University of Minnesota. The series included 301 patients with no CKD, 230 with stage III CKD, and 25 patients with more severe CKD.
The analysis showed a similar incidence of appropriate and inappropriate shocks from the ICDs in all three groups, and roughly similar efficacy of the ICDs for preventing sudden cardiac death, Dr. Selcuk Adabag said at the Annual Scientific Sessions of the American Heart Association. But mortality rates rose substantially higher as renal function worsened, rising from 17% in patients without CKD to 30% in those with stage III disease, and to 56% in those with stage IV or V disease, reported Dr. Adabag, a cardiac electrophysiologist at the University of Minnesota in Minneapolis.
The mortality differences were hardly surprising, and they likely have little direct relationship to the ICDs. "In patients with CKD, the worse the disease, the worse their prognosis. CKD is a complex disease with a whole range of [mortality] risk factors; preventable sudden cardiac death is just one" of the risks these patients face, Dr. Varosy said in an interview.
Selection bias makes the ICD observations questionable, Dr. Reynolds said. "I’m very concerned about concluding that ICDs have similar effectiveness in patients with stage IV or V CKD, compared with no CKD. The study had only 25 patients with stage IV or V disease. I have to think that there was some belief that these were good candidates and that there were a lot of other patients with severe CKD where a physician decided not to implant an ICD. Those patients are not represented in the data," Dr. Reynolds said.
Another study ran a pair of meta-analyses to explore the interactions of ICDs and CKD. In both analyses, CKD was defined as patients on dialysis, those with a creatinine clearance of less than 60 mL/kg per 1.73 m2, or patients with a serum creatinine of at least 1.5 mg/dL.
The first analysis looked at the impact of ICDs on all-cause death among CKD patients at high risk for sudden cardiac death. The literature search found five reports that addressed this issue, in a total of 17,460 patients, which showed that ICD placement linked with a statistically significant 35% cut in total mortality, compared with similar, propensity-score matched patients who did not get ICDs, Dr. Nader Makki said at the meeting.
The second analysis involved 15 reports with 5,333 patients, and used multivariate adjustment to find that patients who had received an ICD and also had CKD had a statistically significant, 2.9-fold higher mortality rate than did ICD recipients without CKD, highlighting the high risk for nonarrhythmic death that CKD patients face, said Dr. Makki, a researcher at the University of Iowa in Iowa City. "Despite a paucity of randomized trials in the CKD population, these data support use of ICDs for the prevention of sudden cardiac death in patients at risk," he said. "We believe that ICDs are underused in this population," patients with CKD.
But these analyses are compromised by the data they used, said Dr. Reynolds. The data were "heavily weighted with a couple of large studies that used claims data. My concern is the potential for confounding by indication. Patients who get ICDs are somehow not as sick as those who don’t."
The third study looked at the impact of CKD on the aftermath of ICD replacement among the 1,744 patients enrolled in the REPLACE (Implantable Cardiac Pulse Generator Replacement Registry) trial, which tracked the incidence of complications following replacement of ICD generators and leads. Among the enrolled patients, researchers had renal-function data for 1,662 patients. About 80% had either mild or moderate renal dysfunction, while 6% had an estimated GFR less than 30 mL/min per 1.73 m2, and the remained had normal renal function.
The incidence of complications was 15% overall, and the analysis showed roughly this rate across all strata of CKD severity. Even among patients with severe CKD, the complication rate was about 20%, and not significantly different from patients with even normal renal function, Dr. Suneet Mittal reported at the meeting. The split between major and minor complications also varied little by renal function, and the incidence of infections was 1%-2% across all five levels of renal function examined.
But CKD severity played a big role in 6-month mortality. A multivariate analysis showed that CKD stage played a significant role in survival; for each stage of worsened renal function the risk of death rose by 50%. (Other significant predictors were recent heart-failure hospitalization, severe heart failure, treatment with an antiarrhythmic drug, and history of cerebrovascular disease.) In actual numbers, the 6-month mortality rate was 2% among patients with either none or mild renal dysfunction that jumped to a 9% rate in patients with an estimated GFR of 15-29 mL/min per 1.73 m2, and to 16% in those on dialysis, said Dr. Mittal, a cardiac electrophysiologist at Columbia University in New York. The analyses also showed that the increased mortality risk linked to severe CKD became apparent by a month after ICD replacement, and it was not driven by procedure-related complications.
"Why do these patients [with severe CKD] do so much worse? We thought that if we looked at all their complications we’d pick up the reason, but clearly there are things that we have not yet recognized," Dr. Mittal said. "There are a lot of things that we didn’t capture in the study."
Although the analysis shed little light on what was behind the high mortality risk in severe CKD patients, it effectively highlighted how risky ICD replacements are in any patient.
"The incidence of complications, 15%-23%, was striking. It’s substantially greater than what’s been seen in any registry-based data or administrative-based data," said Dr. Varosy. He cited the unique ability of this registry to capture all the minor complications following ICD replacement.
"These are frightening numbers [because] we tell patients that there is a very small risk" from ICD replacement procedures, commented Dr. Kalyanam Shivkumar, professor and director of the University of California Los Angeles Cardiac Arrhythmia Center.
Dr. Reynolds said that he has been a consultant to Medtronic and Biosense Webster and has received research grants from Edwards Lifesciences. Dr. Varosy had no disclosures. Dr. Adabag said that he had received research grants from Medtronic and Boston Scientific. Dr. Makki had no disclosures. The REPLACE registry was sponsored by Biotronik and Dr. Mittal said that has been a consultant to Biotronik. Dr. Shivkumar had no disclosures.
LOS ANGELES – Patients with advanced chronic kidney disease who receive an implantable cardioverter defibrillator are not like other patients who receive these devices.
But results from a trio of studies reported at the meeting show how hard it is for researchers to get a clear handle on what makes chronic kidney disease patients different, whether they have different outcomes than defibrillator recipients without CKD, and what is the best approach for judiciously using implantable cardioverter defibrillators (ICDs) in patients with renal dysfunction.
It’s a particularly relevant question because CKD is linked with a substantially increased risk for sudden cardiac death (patients on dialysis have about a fivefold higher risk for sudden cardiac death, compared with patients with normal or mildly impaired renal function), but patients with CKD were excluded from the major trials that proved the efficacy of ICDs for preventing sudden cardiac death. The lack of data from randomized, prospective trials leaves questions about the efficacy, and perhaps as importantly, the cost efficiency of ICDs in CKD patients.
"Should patients with CKD get ICDs? I don’t know the answer, but I don’t think that, categorically, patients with CKD should be excluded from ICD treatment," commented Dr. Matthew Reynolds, a cardiac electrophysiologist and director of the Economics and Quality of Life Research Center at Harvard Medical School in Boston. But many patients with CKD, especially advanced disease, are not good ICD candidates.
"For a lot of patients with CKD, someone decides not to place an ICD. Those patients are not represented" in studies that focus on ICD recipients, said Dr. Reynolds, who cochaired the session where the three studies were presented.
"For every CKD patients who gets an ICD, an electrophysiologist has made a decision that this was a CKD patient who could benefit. It’s hard to extrapolate from that" to all CKD patients, agreed Dr. Paul Varosy, director of electrophysiology at the Denver Veterans Administration Medical Center. "Patients with CKD who get ICDs are fundamentally different patients."
The aim of one of the studies reported was to assess ICD efficacy in CKD patients by comparing survival between patients with ICDs divided into stage III CKD (an estimated glomerular filtration rate [GFR] of 30-59 mL/min per 1.73 m2), stage IV or V (a GFR of less than mL/min per 1.73 m2), or no CKD. The study examined 3-year follow-up data from 556 patients who received an ICD or similar device during 2006-2010 at the Minneapolis Veterans Administration Medical Center at the University of Minnesota. The series included 301 patients with no CKD, 230 with stage III CKD, and 25 patients with more severe CKD.
The analysis showed a similar incidence of appropriate and inappropriate shocks from the ICDs in all three groups, and roughly similar efficacy of the ICDs for preventing sudden cardiac death, Dr. Selcuk Adabag said at the Annual Scientific Sessions of the American Heart Association. But mortality rates rose substantially higher as renal function worsened, rising from 17% in patients without CKD to 30% in those with stage III disease, and to 56% in those with stage IV or V disease, reported Dr. Adabag, a cardiac electrophysiologist at the University of Minnesota in Minneapolis.
The mortality differences were hardly surprising, and they likely have little direct relationship to the ICDs. "In patients with CKD, the worse the disease, the worse their prognosis. CKD is a complex disease with a whole range of [mortality] risk factors; preventable sudden cardiac death is just one" of the risks these patients face, Dr. Varosy said in an interview.
Selection bias makes the ICD observations questionable, Dr. Reynolds said. "I’m very concerned about concluding that ICDs have similar effectiveness in patients with stage IV or V CKD, compared with no CKD. The study had only 25 patients with stage IV or V disease. I have to think that there was some belief that these were good candidates and that there were a lot of other patients with severe CKD where a physician decided not to implant an ICD. Those patients are not represented in the data," Dr. Reynolds said.
Another study ran a pair of meta-analyses to explore the interactions of ICDs and CKD. In both analyses, CKD was defined as patients on dialysis, those with a creatinine clearance of less than 60 mL/kg per 1.73 m2, or patients with a serum creatinine of at least 1.5 mg/dL.
The first analysis looked at the impact of ICDs on all-cause death among CKD patients at high risk for sudden cardiac death. The literature search found five reports that addressed this issue, in a total of 17,460 patients, which showed that ICD placement linked with a statistically significant 35% cut in total mortality, compared with similar, propensity-score matched patients who did not get ICDs, Dr. Nader Makki said at the meeting.
The second analysis involved 15 reports with 5,333 patients, and used multivariate adjustment to find that patients who had received an ICD and also had CKD had a statistically significant, 2.9-fold higher mortality rate than did ICD recipients without CKD, highlighting the high risk for nonarrhythmic death that CKD patients face, said Dr. Makki, a researcher at the University of Iowa in Iowa City. "Despite a paucity of randomized trials in the CKD population, these data support use of ICDs for the prevention of sudden cardiac death in patients at risk," he said. "We believe that ICDs are underused in this population," patients with CKD.
But these analyses are compromised by the data they used, said Dr. Reynolds. The data were "heavily weighted with a couple of large studies that used claims data. My concern is the potential for confounding by indication. Patients who get ICDs are somehow not as sick as those who don’t."
The third study looked at the impact of CKD on the aftermath of ICD replacement among the 1,744 patients enrolled in the REPLACE (Implantable Cardiac Pulse Generator Replacement Registry) trial, which tracked the incidence of complications following replacement of ICD generators and leads. Among the enrolled patients, researchers had renal-function data for 1,662 patients. About 80% had either mild or moderate renal dysfunction, while 6% had an estimated GFR less than 30 mL/min per 1.73 m2, and the remained had normal renal function.
The incidence of complications was 15% overall, and the analysis showed roughly this rate across all strata of CKD severity. Even among patients with severe CKD, the complication rate was about 20%, and not significantly different from patients with even normal renal function, Dr. Suneet Mittal reported at the meeting. The split between major and minor complications also varied little by renal function, and the incidence of infections was 1%-2% across all five levels of renal function examined.
But CKD severity played a big role in 6-month mortality. A multivariate analysis showed that CKD stage played a significant role in survival; for each stage of worsened renal function the risk of death rose by 50%. (Other significant predictors were recent heart-failure hospitalization, severe heart failure, treatment with an antiarrhythmic drug, and history of cerebrovascular disease.) In actual numbers, the 6-month mortality rate was 2% among patients with either none or mild renal dysfunction that jumped to a 9% rate in patients with an estimated GFR of 15-29 mL/min per 1.73 m2, and to 16% in those on dialysis, said Dr. Mittal, a cardiac electrophysiologist at Columbia University in New York. The analyses also showed that the increased mortality risk linked to severe CKD became apparent by a month after ICD replacement, and it was not driven by procedure-related complications.
"Why do these patients [with severe CKD] do so much worse? We thought that if we looked at all their complications we’d pick up the reason, but clearly there are things that we have not yet recognized," Dr. Mittal said. "There are a lot of things that we didn’t capture in the study."
Although the analysis shed little light on what was behind the high mortality risk in severe CKD patients, it effectively highlighted how risky ICD replacements are in any patient.
"The incidence of complications, 15%-23%, was striking. It’s substantially greater than what’s been seen in any registry-based data or administrative-based data," said Dr. Varosy. He cited the unique ability of this registry to capture all the minor complications following ICD replacement.
"These are frightening numbers [because] we tell patients that there is a very small risk" from ICD replacement procedures, commented Dr. Kalyanam Shivkumar, professor and director of the University of California Los Angeles Cardiac Arrhythmia Center.
Dr. Reynolds said that he has been a consultant to Medtronic and Biosense Webster and has received research grants from Edwards Lifesciences. Dr. Varosy had no disclosures. Dr. Adabag said that he had received research grants from Medtronic and Boston Scientific. Dr. Makki had no disclosures. The REPLACE registry was sponsored by Biotronik and Dr. Mittal said that has been a consultant to Biotronik. Dr. Shivkumar had no disclosures.
AT THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN HEART ASSOCIATION
Early results promising for micropump in heart failure
SEATTLE – A tiny pump that provides partial support to patients with heart failure may improve outcomes, at least in the short term, for those in the earlier stages of the disease, clinical experience with the device has shown.
The 20 patients in Belgium and Germany who underwent implantation of the newest version of the investigational device had significantly improved hemodynamics, exercise tolerance, and end organ function at a median of 12 weeks’ follow-up, Dr. Daniel Burkhoff reported at the annual meeting of the Heart Failure Society of America.
The rate of adverse events was about 10 per patient-year in the first month after implantation and roughly 3 per patient-year thereafter.
The findings suggest that "significant and sustained improvements in hemodynamics, exercise capacity, and quality of life can be achieved in this population," commented Dr. Burkhoff of Columbia University in New York and also medical director of CircuLite.
The micropump (known as the Synergy System and manufactured by CircuLite in Saddle Brook, N.J.) received the CE mark for use in Europe in September.
Discussant Dr. Robert L. Kormos of the University of Pittsburgh Medical Center maintained that longer-term data will be needed to assess true sustainability of the results. He also questioned whether the 20 patients described were similar clinically to the entire group of 58 patients who have received some version of the device.
It’s unclear at this point if a U.S. trial designed for Food and Drug Administration approval will focus on a combined heart failure indication versus that of a separate indication as a bridge to transplant or destination therapy, he said.
"The trial suggested that a major reduction in adverse events compared to those seen with contemporary LVADs [left ventricular assist devices] can be achieved through the strategy of early implantation in the spectrum of heart failure and the minimally invasive approach that was used," Dr. Kormos commented. However, the relative contributions of patient selection and the device to this favorable outcome were unclear, he added.
"I do consider this in many respects a landmark [study]. This opens a window to a new therapy that many of us, especially as surgeons, are looking forward to, specifically because it allows us to operate on a group of patients who have fewer comorbidities than we currently see," he concluded.
The patients in the study had heart failure with Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 4 or higher disease, corresponding to New York Heart Association class III or IV, and were symptomatic despite appropriate medical therapy and cardiac resynchronization therapy. They were ambulatory, were not dependent on inotropes, and had recently had a hospitalization and/or increasing medical visits.
The device was used for any of three management strategies, Dr. Burkhoff noted: bridge to transplant, destination therapy, or bridge to decision. "We have not made a distinction between these because especially in Europe, the wait times for heart transplant are so long that these traditional boundaries are really being blurred," he explained.
The patients underwent implantation of the micropump, which is the size of a AA battery, weighs 25 g, and pumps 1.5-4.25 L/min. It is implanted subcutaneously and extrathoracically in a pacemaker pocket with an off-pump minithoracotomy procedure. The device pumps blood from the left atrium to the subclavian artery to increase circulation.
Of the 20 patients who received the most current version of the device, 82% had an implantable cardioverter-defibrillator and 65% had had cardiac resynchronization therapy.
"In terms of the postoperative care, it’s important to consider the differences between this and other VADs [ventricular assist devices]," Dr. Burkhoff maintained, noting the typically short times with the micropump to extubation (within hours), chest tube removal (1 day), and ambulation (1-2 days).
"In terms of the hemodynamic effectiveness, these data show that use of this partial support device can really interrupt and reverse the hemodynamic derangements of heart failure," he said.
Specifically, at a median follow-up of 12 weeks, patients had significant improvements from baseline in cardiac output (by about 1 L/min), pulmonary capillary wedge pressure (10 mm Hg), central venous pressure (5 mm Hg), pulmonary artery pressures (5-15 mm Hg), and pulmonary vascular resistance (1 Wood unit).
Because the device provides only partial cardiac support, the heart still beats regularly; thus, arterial systolic and diastolic pressures did not change significantly, and normal pulsatility in the arterial system was preserved.
Patients also had significant improvements in exercise tolerance as assessed with the 6-minute walk test (by 120 m) and peak VO2 (1.6 mL/kg per minute), and in end organ function, as assessed from creatinine level (0.5 mg/dL), but not in total bilirubin level (0.2 m/dL.
The rate of adverse events, predominantly bleeding, was 9.9 per patient-year in the first month after implantation and 2.5 per patient-year thereafter.
There were three deaths due to perioperative complications; two were related to bleeding, and one was related to a stroke after administration of two doses of vitamin K.
Taken together, the adverse events and deaths "remind us that this is still a surgical procedure, and patients are exposed to certain risks," he said.
Dr. Burkhoff disclosed that he is medical director of and a stockholder in CircuLite. Dr. Kormos disclosed that he receives research support from HeartWare. The study was sponsored by CircuLite.
SEATTLE – A tiny pump that provides partial support to patients with heart failure may improve outcomes, at least in the short term, for those in the earlier stages of the disease, clinical experience with the device has shown.
The 20 patients in Belgium and Germany who underwent implantation of the newest version of the investigational device had significantly improved hemodynamics, exercise tolerance, and end organ function at a median of 12 weeks’ follow-up, Dr. Daniel Burkhoff reported at the annual meeting of the Heart Failure Society of America.
The rate of adverse events was about 10 per patient-year in the first month after implantation and roughly 3 per patient-year thereafter.
The findings suggest that "significant and sustained improvements in hemodynamics, exercise capacity, and quality of life can be achieved in this population," commented Dr. Burkhoff of Columbia University in New York and also medical director of CircuLite.
The micropump (known as the Synergy System and manufactured by CircuLite in Saddle Brook, N.J.) received the CE mark for use in Europe in September.
Discussant Dr. Robert L. Kormos of the University of Pittsburgh Medical Center maintained that longer-term data will be needed to assess true sustainability of the results. He also questioned whether the 20 patients described were similar clinically to the entire group of 58 patients who have received some version of the device.
It’s unclear at this point if a U.S. trial designed for Food and Drug Administration approval will focus on a combined heart failure indication versus that of a separate indication as a bridge to transplant or destination therapy, he said.
"The trial suggested that a major reduction in adverse events compared to those seen with contemporary LVADs [left ventricular assist devices] can be achieved through the strategy of early implantation in the spectrum of heart failure and the minimally invasive approach that was used," Dr. Kormos commented. However, the relative contributions of patient selection and the device to this favorable outcome were unclear, he added.
"I do consider this in many respects a landmark [study]. This opens a window to a new therapy that many of us, especially as surgeons, are looking forward to, specifically because it allows us to operate on a group of patients who have fewer comorbidities than we currently see," he concluded.
The patients in the study had heart failure with Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 4 or higher disease, corresponding to New York Heart Association class III or IV, and were symptomatic despite appropriate medical therapy and cardiac resynchronization therapy. They were ambulatory, were not dependent on inotropes, and had recently had a hospitalization and/or increasing medical visits.
The device was used for any of three management strategies, Dr. Burkhoff noted: bridge to transplant, destination therapy, or bridge to decision. "We have not made a distinction between these because especially in Europe, the wait times for heart transplant are so long that these traditional boundaries are really being blurred," he explained.
The patients underwent implantation of the micropump, which is the size of a AA battery, weighs 25 g, and pumps 1.5-4.25 L/min. It is implanted subcutaneously and extrathoracically in a pacemaker pocket with an off-pump minithoracotomy procedure. The device pumps blood from the left atrium to the subclavian artery to increase circulation.
Of the 20 patients who received the most current version of the device, 82% had an implantable cardioverter-defibrillator and 65% had had cardiac resynchronization therapy.
"In terms of the postoperative care, it’s important to consider the differences between this and other VADs [ventricular assist devices]," Dr. Burkhoff maintained, noting the typically short times with the micropump to extubation (within hours), chest tube removal (1 day), and ambulation (1-2 days).
"In terms of the hemodynamic effectiveness, these data show that use of this partial support device can really interrupt and reverse the hemodynamic derangements of heart failure," he said.
Specifically, at a median follow-up of 12 weeks, patients had significant improvements from baseline in cardiac output (by about 1 L/min), pulmonary capillary wedge pressure (10 mm Hg), central venous pressure (5 mm Hg), pulmonary artery pressures (5-15 mm Hg), and pulmonary vascular resistance (1 Wood unit).
Because the device provides only partial cardiac support, the heart still beats regularly; thus, arterial systolic and diastolic pressures did not change significantly, and normal pulsatility in the arterial system was preserved.
Patients also had significant improvements in exercise tolerance as assessed with the 6-minute walk test (by 120 m) and peak VO2 (1.6 mL/kg per minute), and in end organ function, as assessed from creatinine level (0.5 mg/dL), but not in total bilirubin level (0.2 m/dL.
The rate of adverse events, predominantly bleeding, was 9.9 per patient-year in the first month after implantation and 2.5 per patient-year thereafter.
There were three deaths due to perioperative complications; two were related to bleeding, and one was related to a stroke after administration of two doses of vitamin K.
Taken together, the adverse events and deaths "remind us that this is still a surgical procedure, and patients are exposed to certain risks," he said.
Dr. Burkhoff disclosed that he is medical director of and a stockholder in CircuLite. Dr. Kormos disclosed that he receives research support from HeartWare. The study was sponsored by CircuLite.
SEATTLE – A tiny pump that provides partial support to patients with heart failure may improve outcomes, at least in the short term, for those in the earlier stages of the disease, clinical experience with the device has shown.
The 20 patients in Belgium and Germany who underwent implantation of the newest version of the investigational device had significantly improved hemodynamics, exercise tolerance, and end organ function at a median of 12 weeks’ follow-up, Dr. Daniel Burkhoff reported at the annual meeting of the Heart Failure Society of America.
The rate of adverse events was about 10 per patient-year in the first month after implantation and roughly 3 per patient-year thereafter.
The findings suggest that "significant and sustained improvements in hemodynamics, exercise capacity, and quality of life can be achieved in this population," commented Dr. Burkhoff of Columbia University in New York and also medical director of CircuLite.
The micropump (known as the Synergy System and manufactured by CircuLite in Saddle Brook, N.J.) received the CE mark for use in Europe in September.
Discussant Dr. Robert L. Kormos of the University of Pittsburgh Medical Center maintained that longer-term data will be needed to assess true sustainability of the results. He also questioned whether the 20 patients described were similar clinically to the entire group of 58 patients who have received some version of the device.
It’s unclear at this point if a U.S. trial designed for Food and Drug Administration approval will focus on a combined heart failure indication versus that of a separate indication as a bridge to transplant or destination therapy, he said.
"The trial suggested that a major reduction in adverse events compared to those seen with contemporary LVADs [left ventricular assist devices] can be achieved through the strategy of early implantation in the spectrum of heart failure and the minimally invasive approach that was used," Dr. Kormos commented. However, the relative contributions of patient selection and the device to this favorable outcome were unclear, he added.
"I do consider this in many respects a landmark [study]. This opens a window to a new therapy that many of us, especially as surgeons, are looking forward to, specifically because it allows us to operate on a group of patients who have fewer comorbidities than we currently see," he concluded.
The patients in the study had heart failure with Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 4 or higher disease, corresponding to New York Heart Association class III or IV, and were symptomatic despite appropriate medical therapy and cardiac resynchronization therapy. They were ambulatory, were not dependent on inotropes, and had recently had a hospitalization and/or increasing medical visits.
The device was used for any of three management strategies, Dr. Burkhoff noted: bridge to transplant, destination therapy, or bridge to decision. "We have not made a distinction between these because especially in Europe, the wait times for heart transplant are so long that these traditional boundaries are really being blurred," he explained.
The patients underwent implantation of the micropump, which is the size of a AA battery, weighs 25 g, and pumps 1.5-4.25 L/min. It is implanted subcutaneously and extrathoracically in a pacemaker pocket with an off-pump minithoracotomy procedure. The device pumps blood from the left atrium to the subclavian artery to increase circulation.
Of the 20 patients who received the most current version of the device, 82% had an implantable cardioverter-defibrillator and 65% had had cardiac resynchronization therapy.
"In terms of the postoperative care, it’s important to consider the differences between this and other VADs [ventricular assist devices]," Dr. Burkhoff maintained, noting the typically short times with the micropump to extubation (within hours), chest tube removal (1 day), and ambulation (1-2 days).
"In terms of the hemodynamic effectiveness, these data show that use of this partial support device can really interrupt and reverse the hemodynamic derangements of heart failure," he said.
Specifically, at a median follow-up of 12 weeks, patients had significant improvements from baseline in cardiac output (by about 1 L/min), pulmonary capillary wedge pressure (10 mm Hg), central venous pressure (5 mm Hg), pulmonary artery pressures (5-15 mm Hg), and pulmonary vascular resistance (1 Wood unit).
Because the device provides only partial cardiac support, the heart still beats regularly; thus, arterial systolic and diastolic pressures did not change significantly, and normal pulsatility in the arterial system was preserved.
Patients also had significant improvements in exercise tolerance as assessed with the 6-minute walk test (by 120 m) and peak VO2 (1.6 mL/kg per minute), and in end organ function, as assessed from creatinine level (0.5 mg/dL), but not in total bilirubin level (0.2 m/dL.
The rate of adverse events, predominantly bleeding, was 9.9 per patient-year in the first month after implantation and 2.5 per patient-year thereafter.
There were three deaths due to perioperative complications; two were related to bleeding, and one was related to a stroke after administration of two doses of vitamin K.
Taken together, the adverse events and deaths "remind us that this is still a surgical procedure, and patients are exposed to certain risks," he said.
Dr. Burkhoff disclosed that he is medical director of and a stockholder in CircuLite. Dr. Kormos disclosed that he receives research support from HeartWare. The study was sponsored by CircuLite.
AT THE ANNUAL MEETING OF THE HEART FAILURE SOCIETY OF AMERICA
Major Finding: Patients had significant improvements in hemodynamics, exercise tolerance, and end organ function. The adverse event rates were 9.9 and 2.5 per patient-year in the first month and thereafter, respectively.
Data Source: Data are from a series of 20 patients with heart failure who underwent implantation of the newest version of the micropump system.
Disclosures: Dr. Burkhoff disclosed that he is medical director of and a stockholder in CircuLite. Dr. Kormos disclosed that he receives research support from HeartWare. The study was sponsored by CircuLite.
Dark Chocolate Improves Heart Failure Markers ... Mmmm!
LOS ANGELES – Chronic heart failure patients who ate a special superhigh-flavonol dark chocolate bar daily experienced favorable changes consistent with decreased vascular resistance and diminished left ventricular afterload in a randomized, double-blind, crossover pilot study.
"It should be emphasized that these patients were already on maximal tolerated guideline-indicated therapy. In terms of medical interventions, there weren’t many more things we could do. So I think that in addition to looking at new drugs, we need to look at evidence-based new diets to see if they can reduce morbidity and mortality in heart failure," Dr. Roger Corder said in presenting the chocolate study results at the annual scientific sessions of the American Heart Association.
The likely mechanism of benefit in heart failure patients involves a dark chocolate–induced reduction in endothelial dysfunction.
"Prior studies show consumption of cocoa flavonols in daily doses of 750 mg or more improve endothelial function in patients with coronary artery disease, in healthy subjects, and in diabetics," noted Dr. Corder of Queen Mary University of London.
The study involved 32 patients with stable heart failure on maximal medical therapy, all of whom had a history of ischemic heart disease. They were randomized to daily consumption of a 50-g bar of high-flavonol chocolate or a low-flavonol chocolate bar for 4 weeks, then crossed over to daily consumption of the other bar for another 4 weeks.
The test product contained 1,094 mg of flavonols per bar, while the low-flavonol comparator contained 95 mg. The high-flavonol chocolate bar was a custom-made product whose flavonol content far exceeds anything on the market. Dr. Corder and coinvestigators tested 50 brands of commercially available dark chocolate bars averaging 76% cocoa solids and determined their average flavonol content was 312 mg/50 g.
The study end points were change in diastolic blood pressure and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels after 4 weeks of eating each type of chocolate bar.
Twenty-four patients completed the study. Mean NT-proBNP dropped by an average of 39% from a baseline of 200 pmol/L after 4 weeks of eating the high-flavonol chocolate.
"Given that other trials of medications, including angiotensin receptor blockers, have shown a 30% reduction in NT-proBNP is associated with improved clinical outcomes, this looks to us like something of interest to pursue further with additional clinical studies. It’s worth noting that 12 of the 24 patients had a drop in NT-proBNP of 30% or more," Dr. Corder said.
From a baseline blood pressure of 126/71 mm Hg, diastolic pressure fell by 5 mm Hg in conjunction with consumption of the high-flavonol bar. Systolic pressure did not change significantly. Maintenance of systolic blood pressure with a reduction in diastolic pressure implies an increase in cardiac output – "and that would really be the optimum thing to have happened," he continued.
The low-flavonol chocolate bar did not produce changes in blood pressure or NT-proBNP.
A couple of down sides with the experimental high-flavonol chocolate bar emerged during the study. One was taste. Three of the eight study dropouts quit because they found the product’s taste unacceptable, while the others left for reasons unrelated to the study.
"We had an issue with taste. Even the patients who finished the study didn’t like the taste. There may be other countries where dark chocolate is popular, but the East of London would rather have their sweet milk chocolate than dark chocolate," according to Dr. Corder.
Weight gain is another concern. Both chocolate bars contained about 19 g of fat, including 12 g of saturated fat, per 50-g serving, with about 260 calories. From a baseline body weight of 85.7 kg, participants gained roughly 0.3 kg over the course of 4 weeks.
"In terms of long-term therapy, it may not be suitable to take dark chocolate on a daily basis at this level," he said.
However, food scientists involved in the study are tweaking the recipe to improve the taste of the superhigh-flavonol bar. There is also the option of extracting the flavonols and placing them in some other nutraceutical food product.
The study was funded by Swiss chocolate giant Barry Callebaut. Dr. Corder reported receiving a significant research grant from the company.
LOS ANGELES – Chronic heart failure patients who ate a special superhigh-flavonol dark chocolate bar daily experienced favorable changes consistent with decreased vascular resistance and diminished left ventricular afterload in a randomized, double-blind, crossover pilot study.
"It should be emphasized that these patients were already on maximal tolerated guideline-indicated therapy. In terms of medical interventions, there weren’t many more things we could do. So I think that in addition to looking at new drugs, we need to look at evidence-based new diets to see if they can reduce morbidity and mortality in heart failure," Dr. Roger Corder said in presenting the chocolate study results at the annual scientific sessions of the American Heart Association.
The likely mechanism of benefit in heart failure patients involves a dark chocolate–induced reduction in endothelial dysfunction.
"Prior studies show consumption of cocoa flavonols in daily doses of 750 mg or more improve endothelial function in patients with coronary artery disease, in healthy subjects, and in diabetics," noted Dr. Corder of Queen Mary University of London.
The study involved 32 patients with stable heart failure on maximal medical therapy, all of whom had a history of ischemic heart disease. They were randomized to daily consumption of a 50-g bar of high-flavonol chocolate or a low-flavonol chocolate bar for 4 weeks, then crossed over to daily consumption of the other bar for another 4 weeks.
The test product contained 1,094 mg of flavonols per bar, while the low-flavonol comparator contained 95 mg. The high-flavonol chocolate bar was a custom-made product whose flavonol content far exceeds anything on the market. Dr. Corder and coinvestigators tested 50 brands of commercially available dark chocolate bars averaging 76% cocoa solids and determined their average flavonol content was 312 mg/50 g.
The study end points were change in diastolic blood pressure and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels after 4 weeks of eating each type of chocolate bar.
Twenty-four patients completed the study. Mean NT-proBNP dropped by an average of 39% from a baseline of 200 pmol/L after 4 weeks of eating the high-flavonol chocolate.
"Given that other trials of medications, including angiotensin receptor blockers, have shown a 30% reduction in NT-proBNP is associated with improved clinical outcomes, this looks to us like something of interest to pursue further with additional clinical studies. It’s worth noting that 12 of the 24 patients had a drop in NT-proBNP of 30% or more," Dr. Corder said.
From a baseline blood pressure of 126/71 mm Hg, diastolic pressure fell by 5 mm Hg in conjunction with consumption of the high-flavonol bar. Systolic pressure did not change significantly. Maintenance of systolic blood pressure with a reduction in diastolic pressure implies an increase in cardiac output – "and that would really be the optimum thing to have happened," he continued.
The low-flavonol chocolate bar did not produce changes in blood pressure or NT-proBNP.
A couple of down sides with the experimental high-flavonol chocolate bar emerged during the study. One was taste. Three of the eight study dropouts quit because they found the product’s taste unacceptable, while the others left for reasons unrelated to the study.
"We had an issue with taste. Even the patients who finished the study didn’t like the taste. There may be other countries where dark chocolate is popular, but the East of London would rather have their sweet milk chocolate than dark chocolate," according to Dr. Corder.
Weight gain is another concern. Both chocolate bars contained about 19 g of fat, including 12 g of saturated fat, per 50-g serving, with about 260 calories. From a baseline body weight of 85.7 kg, participants gained roughly 0.3 kg over the course of 4 weeks.
"In terms of long-term therapy, it may not be suitable to take dark chocolate on a daily basis at this level," he said.
However, food scientists involved in the study are tweaking the recipe to improve the taste of the superhigh-flavonol bar. There is also the option of extracting the flavonols and placing them in some other nutraceutical food product.
The study was funded by Swiss chocolate giant Barry Callebaut. Dr. Corder reported receiving a significant research grant from the company.
LOS ANGELES – Chronic heart failure patients who ate a special superhigh-flavonol dark chocolate bar daily experienced favorable changes consistent with decreased vascular resistance and diminished left ventricular afterload in a randomized, double-blind, crossover pilot study.
"It should be emphasized that these patients were already on maximal tolerated guideline-indicated therapy. In terms of medical interventions, there weren’t many more things we could do. So I think that in addition to looking at new drugs, we need to look at evidence-based new diets to see if they can reduce morbidity and mortality in heart failure," Dr. Roger Corder said in presenting the chocolate study results at the annual scientific sessions of the American Heart Association.
The likely mechanism of benefit in heart failure patients involves a dark chocolate–induced reduction in endothelial dysfunction.
"Prior studies show consumption of cocoa flavonols in daily doses of 750 mg or more improve endothelial function in patients with coronary artery disease, in healthy subjects, and in diabetics," noted Dr. Corder of Queen Mary University of London.
The study involved 32 patients with stable heart failure on maximal medical therapy, all of whom had a history of ischemic heart disease. They were randomized to daily consumption of a 50-g bar of high-flavonol chocolate or a low-flavonol chocolate bar for 4 weeks, then crossed over to daily consumption of the other bar for another 4 weeks.
The test product contained 1,094 mg of flavonols per bar, while the low-flavonol comparator contained 95 mg. The high-flavonol chocolate bar was a custom-made product whose flavonol content far exceeds anything on the market. Dr. Corder and coinvestigators tested 50 brands of commercially available dark chocolate bars averaging 76% cocoa solids and determined their average flavonol content was 312 mg/50 g.
The study end points were change in diastolic blood pressure and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels after 4 weeks of eating each type of chocolate bar.
Twenty-four patients completed the study. Mean NT-proBNP dropped by an average of 39% from a baseline of 200 pmol/L after 4 weeks of eating the high-flavonol chocolate.
"Given that other trials of medications, including angiotensin receptor blockers, have shown a 30% reduction in NT-proBNP is associated with improved clinical outcomes, this looks to us like something of interest to pursue further with additional clinical studies. It’s worth noting that 12 of the 24 patients had a drop in NT-proBNP of 30% or more," Dr. Corder said.
From a baseline blood pressure of 126/71 mm Hg, diastolic pressure fell by 5 mm Hg in conjunction with consumption of the high-flavonol bar. Systolic pressure did not change significantly. Maintenance of systolic blood pressure with a reduction in diastolic pressure implies an increase in cardiac output – "and that would really be the optimum thing to have happened," he continued.
The low-flavonol chocolate bar did not produce changes in blood pressure or NT-proBNP.
A couple of down sides with the experimental high-flavonol chocolate bar emerged during the study. One was taste. Three of the eight study dropouts quit because they found the product’s taste unacceptable, while the others left for reasons unrelated to the study.
"We had an issue with taste. Even the patients who finished the study didn’t like the taste. There may be other countries where dark chocolate is popular, but the East of London would rather have their sweet milk chocolate than dark chocolate," according to Dr. Corder.
Weight gain is another concern. Both chocolate bars contained about 19 g of fat, including 12 g of saturated fat, per 50-g serving, with about 260 calories. From a baseline body weight of 85.7 kg, participants gained roughly 0.3 kg over the course of 4 weeks.
"In terms of long-term therapy, it may not be suitable to take dark chocolate on a daily basis at this level," he said.
However, food scientists involved in the study are tweaking the recipe to improve the taste of the superhigh-flavonol bar. There is also the option of extracting the flavonols and placing them in some other nutraceutical food product.
The study was funded by Swiss chocolate giant Barry Callebaut. Dr. Corder reported receiving a significant research grant from the company.
AT THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN HEART ASSOCIATION
Major Finding: Daily consumption of a high-flavonol chocolate bar for 4 weeks by patients with chronic heart failure on optimal medical therapy led to an average 5–mm Hg drop in diastolic blood pressure and a 39% reduction in NT-proBNP.
Data Source: Data are from a prospective, double-blind, randomized crossover study involving 32 patients with stable ischemic cardiomyopathy.
Disclosures: The study was sponsored by Swiss chocolate manufacturer Barry Callebaut.
