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FDA approves Vyndaqel, Vyndamax for amyloidosis-based heart disease
The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.
FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.
No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.
“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.
FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.
No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.
“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.
FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.
No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.
“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
When to transition heart failure patient to alternative loop diuretic
PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.
“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.
When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.
The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.
he added.
The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.
“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.
Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.
The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”
The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.
“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”
If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.
“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.
If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.
Dr. McKie reported no relevant disclosures.
PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.
“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.
When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.
The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.
he added.
The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.
“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.
Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.
The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”
The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.
“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”
If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.
“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.
If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.
Dr. McKie reported no relevant disclosures.
PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.
“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.
When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.
The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.
he added.
The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.
“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.
Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.
The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”
The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.
“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”
If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.
“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.
If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.
Dr. McKie reported no relevant disclosures.
REPORTING FROM INTERNAL MEDICINE 2019
Plant-based diet lowers risk of heart failure
according to an analysis published online in the Journal of the American College of Cardiology.
Conversely, a Southern diet, defined as favoring fried and processed foods, is associated with an increased risk of heart failure. The results support a population-based dietary strategy for decreasing the risk of incident heart failure, according to the investigators.
Campaigns to prevent heart failure often emphasize the maintenance of a healthy diet and weight; however, little research has examined the relationship between dietary patterns and incident heart failure in patients without coronary heart disease.
Kyla M. Lara, MD, postgraduate fellow of cardiology and general internal medicine at the Icahn School of Medicine at Mount Sinai, New York, and colleagues sought to analyze the associations between five dietary patterns and incident hospitalizations for heart failure among adults in the United States. They examined data from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) trial, a prospective study of black and white adults who were followed from 2003-2007 to 2014. Eligible participants completed a food frequency questionnaire and had no coronary heart disease or heart failure at baseline.
The REGARDS researchers’ principal component analysis identified the following five dietary patterns: convenience (for example, Mexican and Chinese dishes and fast food), plant based (for example, vegetables, fruit, and fish), sweets (for example, desserts, breads, and candy), Southern (for example, fried food, processed meats, and sugary beverages), and alcohol/salads. Dr. Lara and colleagues chose incident heart failure hospitalization as their primary endpoint.
The investigators included 16,068 participants in their analysis. Mean age was 64 years, roughly 59% of the sample were women, and 34% were black.
After a median 8.7 years of follow-up, 363 participants had incident heart failure hospitalizations. The highest quartile of adherence to the plant-based dietary pattern was associated with a 41% lower risk of heart failure in multivariate models, compared with the lowest quartile. The highest adherence to the Southern dietary pattern was linked with a 72% higher risk of heart failure after adjustments for age, sex, race, and other potential confounders such as education, income, smoking, and physical activity.
After further adjustments for body mass index, waist circumference, hypertension, dyslipidemia, diabetes mellitus, atrial fibrillation, and chronic kidney disease, the association was attenuated and no longer statistically significant. Dr. Lara and colleagues found no statistically significant associations between incident heart failure with reduced or preserved ejection fraction hospitalizations and the dietary patterns. They also found no associations with the other three dietary patterns.
One researcher reported receiving research funding from Amgen and has consulted for Novartis. The other researchers reported no relevant conflicts.
SOURCE: Lara KM et al. J Am Coll Cardiol. 2019 Apr 30;73(16):2036-45.
This analysis of the REGARDS study contributes toward creating a strong evidence base for the prevention of heart failure through dietary measures, wrote Dong D. Wang, SCD, MD, a visiting scientist at Harvard School of Public Health, Boston, in an accompanying editorial. Empirically derived dietary patterns, such as those described in this study, can form the basis for recommendations easily, he added. “We usually have greater confidence when interpreting the associations with dietary patterns as causal than we have for the associations with specific nutrients or foods. Furthermore, the findings are particularly useful for making recommendations to a general population because of their use of a baseline coronary heart disease–free study population and the inclusion of black participants with greater susceptibility to heart failure. Thus, this study possesses a great potential of informing the population-level strategies for the prevention of heart failure.”
Nutritional epidemiologic studies examining subtypes of heart failure are valuable in light of the disease’s phenotypic and pathophysiological heterogeneity, Dr. Wang wrote. “These findings, if confirmed in future studies, will not only contribute to in-depth biological understanding and phenotypic refinement of heart failure, but also inform dietary prevention approaches customized for specific heart failure phenotypes. In addition, they perfectly fit into key missions of precision medicine [i.e., understanding large variability between individuals in both the development and the clinical manifestations of the specific disease, as well as variability in individual’s response to dietary, lifestyle, and pharmacological interventions].”
Dr. Wang reported no relationships relevant to the contents of this paper.
This analysis of the REGARDS study contributes toward creating a strong evidence base for the prevention of heart failure through dietary measures, wrote Dong D. Wang, SCD, MD, a visiting scientist at Harvard School of Public Health, Boston, in an accompanying editorial. Empirically derived dietary patterns, such as those described in this study, can form the basis for recommendations easily, he added. “We usually have greater confidence when interpreting the associations with dietary patterns as causal than we have for the associations with specific nutrients or foods. Furthermore, the findings are particularly useful for making recommendations to a general population because of their use of a baseline coronary heart disease–free study population and the inclusion of black participants with greater susceptibility to heart failure. Thus, this study possesses a great potential of informing the population-level strategies for the prevention of heart failure.”
Nutritional epidemiologic studies examining subtypes of heart failure are valuable in light of the disease’s phenotypic and pathophysiological heterogeneity, Dr. Wang wrote. “These findings, if confirmed in future studies, will not only contribute to in-depth biological understanding and phenotypic refinement of heart failure, but also inform dietary prevention approaches customized for specific heart failure phenotypes. In addition, they perfectly fit into key missions of precision medicine [i.e., understanding large variability between individuals in both the development and the clinical manifestations of the specific disease, as well as variability in individual’s response to dietary, lifestyle, and pharmacological interventions].”
Dr. Wang reported no relationships relevant to the contents of this paper.
This analysis of the REGARDS study contributes toward creating a strong evidence base for the prevention of heart failure through dietary measures, wrote Dong D. Wang, SCD, MD, a visiting scientist at Harvard School of Public Health, Boston, in an accompanying editorial. Empirically derived dietary patterns, such as those described in this study, can form the basis for recommendations easily, he added. “We usually have greater confidence when interpreting the associations with dietary patterns as causal than we have for the associations with specific nutrients or foods. Furthermore, the findings are particularly useful for making recommendations to a general population because of their use of a baseline coronary heart disease–free study population and the inclusion of black participants with greater susceptibility to heart failure. Thus, this study possesses a great potential of informing the population-level strategies for the prevention of heart failure.”
Nutritional epidemiologic studies examining subtypes of heart failure are valuable in light of the disease’s phenotypic and pathophysiological heterogeneity, Dr. Wang wrote. “These findings, if confirmed in future studies, will not only contribute to in-depth biological understanding and phenotypic refinement of heart failure, but also inform dietary prevention approaches customized for specific heart failure phenotypes. In addition, they perfectly fit into key missions of precision medicine [i.e., understanding large variability between individuals in both the development and the clinical manifestations of the specific disease, as well as variability in individual’s response to dietary, lifestyle, and pharmacological interventions].”
Dr. Wang reported no relationships relevant to the contents of this paper.
according to an analysis published online in the Journal of the American College of Cardiology.
Conversely, a Southern diet, defined as favoring fried and processed foods, is associated with an increased risk of heart failure. The results support a population-based dietary strategy for decreasing the risk of incident heart failure, according to the investigators.
Campaigns to prevent heart failure often emphasize the maintenance of a healthy diet and weight; however, little research has examined the relationship between dietary patterns and incident heart failure in patients without coronary heart disease.
Kyla M. Lara, MD, postgraduate fellow of cardiology and general internal medicine at the Icahn School of Medicine at Mount Sinai, New York, and colleagues sought to analyze the associations between five dietary patterns and incident hospitalizations for heart failure among adults in the United States. They examined data from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) trial, a prospective study of black and white adults who were followed from 2003-2007 to 2014. Eligible participants completed a food frequency questionnaire and had no coronary heart disease or heart failure at baseline.
The REGARDS researchers’ principal component analysis identified the following five dietary patterns: convenience (for example, Mexican and Chinese dishes and fast food), plant based (for example, vegetables, fruit, and fish), sweets (for example, desserts, breads, and candy), Southern (for example, fried food, processed meats, and sugary beverages), and alcohol/salads. Dr. Lara and colleagues chose incident heart failure hospitalization as their primary endpoint.
The investigators included 16,068 participants in their analysis. Mean age was 64 years, roughly 59% of the sample were women, and 34% were black.
After a median 8.7 years of follow-up, 363 participants had incident heart failure hospitalizations. The highest quartile of adherence to the plant-based dietary pattern was associated with a 41% lower risk of heart failure in multivariate models, compared with the lowest quartile. The highest adherence to the Southern dietary pattern was linked with a 72% higher risk of heart failure after adjustments for age, sex, race, and other potential confounders such as education, income, smoking, and physical activity.
After further adjustments for body mass index, waist circumference, hypertension, dyslipidemia, diabetes mellitus, atrial fibrillation, and chronic kidney disease, the association was attenuated and no longer statistically significant. Dr. Lara and colleagues found no statistically significant associations between incident heart failure with reduced or preserved ejection fraction hospitalizations and the dietary patterns. They also found no associations with the other three dietary patterns.
One researcher reported receiving research funding from Amgen and has consulted for Novartis. The other researchers reported no relevant conflicts.
SOURCE: Lara KM et al. J Am Coll Cardiol. 2019 Apr 30;73(16):2036-45.
according to an analysis published online in the Journal of the American College of Cardiology.
Conversely, a Southern diet, defined as favoring fried and processed foods, is associated with an increased risk of heart failure. The results support a population-based dietary strategy for decreasing the risk of incident heart failure, according to the investigators.
Campaigns to prevent heart failure often emphasize the maintenance of a healthy diet and weight; however, little research has examined the relationship between dietary patterns and incident heart failure in patients without coronary heart disease.
Kyla M. Lara, MD, postgraduate fellow of cardiology and general internal medicine at the Icahn School of Medicine at Mount Sinai, New York, and colleagues sought to analyze the associations between five dietary patterns and incident hospitalizations for heart failure among adults in the United States. They examined data from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) trial, a prospective study of black and white adults who were followed from 2003-2007 to 2014. Eligible participants completed a food frequency questionnaire and had no coronary heart disease or heart failure at baseline.
The REGARDS researchers’ principal component analysis identified the following five dietary patterns: convenience (for example, Mexican and Chinese dishes and fast food), plant based (for example, vegetables, fruit, and fish), sweets (for example, desserts, breads, and candy), Southern (for example, fried food, processed meats, and sugary beverages), and alcohol/salads. Dr. Lara and colleagues chose incident heart failure hospitalization as their primary endpoint.
The investigators included 16,068 participants in their analysis. Mean age was 64 years, roughly 59% of the sample were women, and 34% were black.
After a median 8.7 years of follow-up, 363 participants had incident heart failure hospitalizations. The highest quartile of adherence to the plant-based dietary pattern was associated with a 41% lower risk of heart failure in multivariate models, compared with the lowest quartile. The highest adherence to the Southern dietary pattern was linked with a 72% higher risk of heart failure after adjustments for age, sex, race, and other potential confounders such as education, income, smoking, and physical activity.
After further adjustments for body mass index, waist circumference, hypertension, dyslipidemia, diabetes mellitus, atrial fibrillation, and chronic kidney disease, the association was attenuated and no longer statistically significant. Dr. Lara and colleagues found no statistically significant associations between incident heart failure with reduced or preserved ejection fraction hospitalizations and the dietary patterns. They also found no associations with the other three dietary patterns.
One researcher reported receiving research funding from Amgen and has consulted for Novartis. The other researchers reported no relevant conflicts.
SOURCE: Lara KM et al. J Am Coll Cardiol. 2019 Apr 30;73(16):2036-45.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Plant-based and Southern diets influence the risk of heart failure.
Major finding: Adherence to a plant-based diet reduces the risk of heart failure by 41%.
Study details: An analysis of data for 16,068 participants in the REGARDS study.
Disclosures: One coauthor reported receiving research funding from Amgen and has consulted for Novartis.
Source: Lara KM et al. J Am Coll Cardiol. 2019 Apr 30;73(16):2036-45.
PIONEER-HF Extension: Don’t stall starting sacubitril/valsartan
NEW ORLEANS – Waiting a few months after a patient has been hospitalized for acute decompensated heart failure before launching a switch from enalapril to sacubitril/valsartan imposes a steep price in terms of extra major cardiovascular events, compared with starting the angiotensin-neprilysin inhibitor during the initial hospitalization, according to the open-label extension of the PIONEER-HF trial.
“We think these data have important clinical implications: While sacubitril/valsartan decreases NT-proBNP compared with enalapril regardless of when it is initiated, the early improvement in postdischarge outcomes supports the in-hospital initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure,” Adam D. DeVore, MD, declared in presenting the PIONEER-HF Extension results at the annual meeting of the American College of Cardiology.
PIONEER-HF was a landmark, practice-changing, double-blind clinical trial in which 881 patients were randomized to initiation of sacubitril/valsartan (Entresto) or enalapril during hospitalization for acute decompensated heart failure. In the previously reported main outcome, 8 weeks after discharge the sacubitril/valsartan group had a 29% greater reduction in NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) and a 42% lower rate of the composite clinical endpoint of cardiovascular death or heart failure rehospitalization than the enalapril group (N Engl J Med. 2019 Feb 7;380[6]:539-48).
The 4-week open-label extension of PIONEER-HF began at week 8, when participants initially randomized to enalapril during the double-blind phase were switched to sacubitril/valsartan, while those assigned to in-hospital initiation of the angiotensin-neprilysin inhibitor (ARNI) stayed the course.
At week 12, after 4 weeks of open-label treatment, patients on sacubitril/valsartan from the start experienced an additional 18.5% drop in NT-proBNP from their week-8 baseline of 1,218 pg/mL. Meanwhile, the NT-proBNP level in the switch group plunged by 35.8% from a week-8 baseline of 1,630 pg/mL. As a result, both groups ended up at the same much-improved biomarker level at week 12, observed Dr. DeVore, a cardiologist at Duke University in Durham, N.C.
Clinical event rates, however, were another story altogether. The clinical event gap between the two study arms documented at week 8 in the double-blind phase of the trial didn’t close significantly in the 4 weeks after the enalapril group crossed over to open-label sacubitril/valsartan. Indeed, the relative risk of the composite endpoint of cardiovascular death, heart failure rehospitalization, or left ventricular assist device implantation during the 4-week extension phase was 33% lower in the continuous sacubitril/valsartan group than in the switchers. The absolute risk reduction was 5.6%, with a favorable number needed to treat of 18.
This difference was driven mainly by less rehospitalization for heart failure. Few cardiovascular deaths or LVAD implantations occurred during the relatively brief 4-week extension phase of the trial.
“But this is an important thing as we think about what we’re trying to accomplish in heart failure: trying to find tools that improve rehospitalization rates after people leave the hospital is extremely important,” Dr. DeVore said. “We do know that the really vulnerable period for rehospitalization is early on, so my sus```picion – though I can’t prove it – is that’s the important part. That’s when we need to have patients on the best therapy.”
He was asked how practical it is to initiate sacubitril/valsartan during hospitalization for acute decompensated heart failure in real-world clinical practice, given that it can be done only after patients achieve hemodynamic stability.
“I think the definition of hemodynamic stability we used in the trial was a fairly straightforward one, very clinical, and one we can translate to the bedside,” Dr. DeVore replied. “Patients had to have a systolic blood pressure of 100 mm Hg or greater for 6 hours, which is easily documented in the hospital, no changes in IV diuretics or IV vasodilators for 6 hours, and no IV inotropes for the last 24 hours. That’s how we defined hemodynamic stability. I think we should be able to find these patients.”
Average length of stay in the index hospitalization in PIONEER-HF was just over 5 days, but the study protocol actually resulted in longer-than-needed hospitalization because it required that patients had to receive three double-blind doses of their study medication before discharge. In routine practice, it’s unlikely that in-hospital initiation of sacubitril/valsartan will result in a length of stay greater than the national average of about 4.5 days, according the cardiologist.
Current ACC/American Heart Association/Heart Failure Society of American guidelines on management of heart failure include a Class Ia recommendation to switch patients from an ACE inhibitor or angiotensin inhibitor to sacubitril/valsartan (Circulation. 2017 Aug 8;136[6]:e137-61).
However, heart failure specialists are concerned by national data showing that sacubitril/valsartan remains widely underprescribed.
Dr. DeVore reported serving as a consultant to Novartis and receiving research grants from a half dozen pharmaceutical companies as well as the American Heart Association, National Heart, Lung, and Blood Institute, and the Patient-Centered Outcomes Research Institute .
NEW ORLEANS – Waiting a few months after a patient has been hospitalized for acute decompensated heart failure before launching a switch from enalapril to sacubitril/valsartan imposes a steep price in terms of extra major cardiovascular events, compared with starting the angiotensin-neprilysin inhibitor during the initial hospitalization, according to the open-label extension of the PIONEER-HF trial.
“We think these data have important clinical implications: While sacubitril/valsartan decreases NT-proBNP compared with enalapril regardless of when it is initiated, the early improvement in postdischarge outcomes supports the in-hospital initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure,” Adam D. DeVore, MD, declared in presenting the PIONEER-HF Extension results at the annual meeting of the American College of Cardiology.
PIONEER-HF was a landmark, practice-changing, double-blind clinical trial in which 881 patients were randomized to initiation of sacubitril/valsartan (Entresto) or enalapril during hospitalization for acute decompensated heart failure. In the previously reported main outcome, 8 weeks after discharge the sacubitril/valsartan group had a 29% greater reduction in NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) and a 42% lower rate of the composite clinical endpoint of cardiovascular death or heart failure rehospitalization than the enalapril group (N Engl J Med. 2019 Feb 7;380[6]:539-48).
The 4-week open-label extension of PIONEER-HF began at week 8, when participants initially randomized to enalapril during the double-blind phase were switched to sacubitril/valsartan, while those assigned to in-hospital initiation of the angiotensin-neprilysin inhibitor (ARNI) stayed the course.
At week 12, after 4 weeks of open-label treatment, patients on sacubitril/valsartan from the start experienced an additional 18.5% drop in NT-proBNP from their week-8 baseline of 1,218 pg/mL. Meanwhile, the NT-proBNP level in the switch group plunged by 35.8% from a week-8 baseline of 1,630 pg/mL. As a result, both groups ended up at the same much-improved biomarker level at week 12, observed Dr. DeVore, a cardiologist at Duke University in Durham, N.C.
Clinical event rates, however, were another story altogether. The clinical event gap between the two study arms documented at week 8 in the double-blind phase of the trial didn’t close significantly in the 4 weeks after the enalapril group crossed over to open-label sacubitril/valsartan. Indeed, the relative risk of the composite endpoint of cardiovascular death, heart failure rehospitalization, or left ventricular assist device implantation during the 4-week extension phase was 33% lower in the continuous sacubitril/valsartan group than in the switchers. The absolute risk reduction was 5.6%, with a favorable number needed to treat of 18.
This difference was driven mainly by less rehospitalization for heart failure. Few cardiovascular deaths or LVAD implantations occurred during the relatively brief 4-week extension phase of the trial.
“But this is an important thing as we think about what we’re trying to accomplish in heart failure: trying to find tools that improve rehospitalization rates after people leave the hospital is extremely important,” Dr. DeVore said. “We do know that the really vulnerable period for rehospitalization is early on, so my sus```picion – though I can’t prove it – is that’s the important part. That’s when we need to have patients on the best therapy.”
He was asked how practical it is to initiate sacubitril/valsartan during hospitalization for acute decompensated heart failure in real-world clinical practice, given that it can be done only after patients achieve hemodynamic stability.
“I think the definition of hemodynamic stability we used in the trial was a fairly straightforward one, very clinical, and one we can translate to the bedside,” Dr. DeVore replied. “Patients had to have a systolic blood pressure of 100 mm Hg or greater for 6 hours, which is easily documented in the hospital, no changes in IV diuretics or IV vasodilators for 6 hours, and no IV inotropes for the last 24 hours. That’s how we defined hemodynamic stability. I think we should be able to find these patients.”
Average length of stay in the index hospitalization in PIONEER-HF was just over 5 days, but the study protocol actually resulted in longer-than-needed hospitalization because it required that patients had to receive three double-blind doses of their study medication before discharge. In routine practice, it’s unlikely that in-hospital initiation of sacubitril/valsartan will result in a length of stay greater than the national average of about 4.5 days, according the cardiologist.
Current ACC/American Heart Association/Heart Failure Society of American guidelines on management of heart failure include a Class Ia recommendation to switch patients from an ACE inhibitor or angiotensin inhibitor to sacubitril/valsartan (Circulation. 2017 Aug 8;136[6]:e137-61).
However, heart failure specialists are concerned by national data showing that sacubitril/valsartan remains widely underprescribed.
Dr. DeVore reported serving as a consultant to Novartis and receiving research grants from a half dozen pharmaceutical companies as well as the American Heart Association, National Heart, Lung, and Blood Institute, and the Patient-Centered Outcomes Research Institute .
NEW ORLEANS – Waiting a few months after a patient has been hospitalized for acute decompensated heart failure before launching a switch from enalapril to sacubitril/valsartan imposes a steep price in terms of extra major cardiovascular events, compared with starting the angiotensin-neprilysin inhibitor during the initial hospitalization, according to the open-label extension of the PIONEER-HF trial.
“We think these data have important clinical implications: While sacubitril/valsartan decreases NT-proBNP compared with enalapril regardless of when it is initiated, the early improvement in postdischarge outcomes supports the in-hospital initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure,” Adam D. DeVore, MD, declared in presenting the PIONEER-HF Extension results at the annual meeting of the American College of Cardiology.
PIONEER-HF was a landmark, practice-changing, double-blind clinical trial in which 881 patients were randomized to initiation of sacubitril/valsartan (Entresto) or enalapril during hospitalization for acute decompensated heart failure. In the previously reported main outcome, 8 weeks after discharge the sacubitril/valsartan group had a 29% greater reduction in NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) and a 42% lower rate of the composite clinical endpoint of cardiovascular death or heart failure rehospitalization than the enalapril group (N Engl J Med. 2019 Feb 7;380[6]:539-48).
The 4-week open-label extension of PIONEER-HF began at week 8, when participants initially randomized to enalapril during the double-blind phase were switched to sacubitril/valsartan, while those assigned to in-hospital initiation of the angiotensin-neprilysin inhibitor (ARNI) stayed the course.
At week 12, after 4 weeks of open-label treatment, patients on sacubitril/valsartan from the start experienced an additional 18.5% drop in NT-proBNP from their week-8 baseline of 1,218 pg/mL. Meanwhile, the NT-proBNP level in the switch group plunged by 35.8% from a week-8 baseline of 1,630 pg/mL. As a result, both groups ended up at the same much-improved biomarker level at week 12, observed Dr. DeVore, a cardiologist at Duke University in Durham, N.C.
Clinical event rates, however, were another story altogether. The clinical event gap between the two study arms documented at week 8 in the double-blind phase of the trial didn’t close significantly in the 4 weeks after the enalapril group crossed over to open-label sacubitril/valsartan. Indeed, the relative risk of the composite endpoint of cardiovascular death, heart failure rehospitalization, or left ventricular assist device implantation during the 4-week extension phase was 33% lower in the continuous sacubitril/valsartan group than in the switchers. The absolute risk reduction was 5.6%, with a favorable number needed to treat of 18.
This difference was driven mainly by less rehospitalization for heart failure. Few cardiovascular deaths or LVAD implantations occurred during the relatively brief 4-week extension phase of the trial.
“But this is an important thing as we think about what we’re trying to accomplish in heart failure: trying to find tools that improve rehospitalization rates after people leave the hospital is extremely important,” Dr. DeVore said. “We do know that the really vulnerable period for rehospitalization is early on, so my sus```picion – though I can’t prove it – is that’s the important part. That’s when we need to have patients on the best therapy.”
He was asked how practical it is to initiate sacubitril/valsartan during hospitalization for acute decompensated heart failure in real-world clinical practice, given that it can be done only after patients achieve hemodynamic stability.
“I think the definition of hemodynamic stability we used in the trial was a fairly straightforward one, very clinical, and one we can translate to the bedside,” Dr. DeVore replied. “Patients had to have a systolic blood pressure of 100 mm Hg or greater for 6 hours, which is easily documented in the hospital, no changes in IV diuretics or IV vasodilators for 6 hours, and no IV inotropes for the last 24 hours. That’s how we defined hemodynamic stability. I think we should be able to find these patients.”
Average length of stay in the index hospitalization in PIONEER-HF was just over 5 days, but the study protocol actually resulted in longer-than-needed hospitalization because it required that patients had to receive three double-blind doses of their study medication before discharge. In routine practice, it’s unlikely that in-hospital initiation of sacubitril/valsartan will result in a length of stay greater than the national average of about 4.5 days, according the cardiologist.
Current ACC/American Heart Association/Heart Failure Society of American guidelines on management of heart failure include a Class Ia recommendation to switch patients from an ACE inhibitor or angiotensin inhibitor to sacubitril/valsartan (Circulation. 2017 Aug 8;136[6]:e137-61).
However, heart failure specialists are concerned by national data showing that sacubitril/valsartan remains widely underprescribed.
Dr. DeVore reported serving as a consultant to Novartis and receiving research grants from a half dozen pharmaceutical companies as well as the American Heart Association, National Heart, Lung, and Blood Institute, and the Patient-Centered Outcomes Research Institute .
REPORTING FROM ACC 19
Key clinical point: over the next 12 weeks, compared with initiation of enalapril followed by a delayed switch to sacubitril/valsartan at 8 weeks.
Major finding: The number needed to treat with in-hospital initiation of sacubitril/valsartan instead of enalapril to avoid one cardiovascular death, heart failure rehospitalization, or implantation of a left ventricular assist device was 18.
Study details: The PIONEER-HF Extension study included 881 heart failure patients, all on open-label sacubitril/valsartan during the 4-week extension phase.
Disclosures: The study was sponsored by AstraZeneca. The presenter reported receiving research grants from and serving as a consultant to the company.
Clinicians, CMS confer over heart failure–readmission penalty
NEW ORLEANS – Mounting evidence shows that heart failure patient mortality increased as an unintended consequence of a Medicare program that penalizes hospitals with too many 30-day readmissions of heart failure patients. This has prompted discussions among cardiologists, Medicare officials, and other stakeholders in an attempt to modify the penalty program so it no longer considers just readmissions but instead bases penalties on broader and more nuanced measures of patient outcomes.
Staffers at the Centers for Medicare & Medicaid Services, the federal agency that manages Medicare, “said that they take this seriously and will look into it, and they are interested in next-generation measures that are more patient centered” than simply the 30-day readmission rate, Gregg C. Fonarow, MD, said in an interview at the annual meeting of the American College of Cardiology. “This is a case where there is credible evidence of increased mortality that is consistent, reproducible, and strongly associated with the penalty and cannot be otherwise explained,” said Dr. Fonarow, professor of medicine and cochief of cardiology at the University of California, Los Angeles.
He is among the most active researchers to document that, while CMS’s Hospital Readmissions Reduction Program (HRRP) led to significantly reduced readmission rates in patients with heart failure, this came at a cost of a significant increase in mortality among the same patients. For example, an article he published in 2018 that analyzed more than 115,000 Medicare beneficiaries during 2006-2014 showed that during the penalty phase, which began in 2012, readmissions fell after adjustment by a relative 8%, but adjusted mortality rose by a relative 10%, compared with how patients had fared prior to launching the HRRP (JAMA Cardiol. 2018 Jan;3[1]:44-53). Recent reports from other research groups have had similar findings, such as a study of more than 3 million Medicare beneficiaries with heart failure during 2005-2015 that also showed significantly increased mortality after the penalty phase for readmissions began (JAMA. 2018 Dec 25;320[24]:2542-52). In a commentary that accompanied this report, Dr. Fonarow cited the multiple analyses that show consistent findings and the need for CMS to “initiate an expeditious reconsideration and revision” of their current approach to penalizing hospitals for heart failure readmissions (JAMA. 2018 Dec 25;320[24]:2539-41).
The groups recently in discussion with CMS about this issue include the American College of Cardiology, the American Heart Association, the Heart Failure Society of America, the American College of Physicians, the American Hospital Association, and several other medical professional groups, said Biykem Bozkurt, MD, who has worked with Dr. Fonarow and representatives from these organizations in talks with CMS.
“We are trying to find a harmonized approach with patient-centric outcomes that reflect true improvements in quality of care,” she said in an interview. One possibility up for consideration is a combined measure of heart failure readmissions, mortality, and a patient-reported outcome. The measure would go to CMS directly from each patient’s electronic medical record, making data collection less burdensome to clinicians, said Dr. Bozkurt, professor of medicine at Baylor College of Medicine and cardiology section chief at the VA Medical Center in Houston. She expressed hope that a change in the CMS metric might happen later this year.
“CMS can’t simply stop the HRRP, so the discussion is on how to get a meaningful change. I’m increasingly optimistic, because the findings of harm [from current policies] are impossible to ignore,” Dr. Fonarow said. “There will be increasing pressure on CMS to develop a pathway to make modifications. It’s egregious to continue a policy that’s been associated with harm” to heart failure patients.
Dr. Fonarow and Dr. Bozkurt had no relevant commercial disclosures.
NEW ORLEANS – Mounting evidence shows that heart failure patient mortality increased as an unintended consequence of a Medicare program that penalizes hospitals with too many 30-day readmissions of heart failure patients. This has prompted discussions among cardiologists, Medicare officials, and other stakeholders in an attempt to modify the penalty program so it no longer considers just readmissions but instead bases penalties on broader and more nuanced measures of patient outcomes.
Staffers at the Centers for Medicare & Medicaid Services, the federal agency that manages Medicare, “said that they take this seriously and will look into it, and they are interested in next-generation measures that are more patient centered” than simply the 30-day readmission rate, Gregg C. Fonarow, MD, said in an interview at the annual meeting of the American College of Cardiology. “This is a case where there is credible evidence of increased mortality that is consistent, reproducible, and strongly associated with the penalty and cannot be otherwise explained,” said Dr. Fonarow, professor of medicine and cochief of cardiology at the University of California, Los Angeles.
He is among the most active researchers to document that, while CMS’s Hospital Readmissions Reduction Program (HRRP) led to significantly reduced readmission rates in patients with heart failure, this came at a cost of a significant increase in mortality among the same patients. For example, an article he published in 2018 that analyzed more than 115,000 Medicare beneficiaries during 2006-2014 showed that during the penalty phase, which began in 2012, readmissions fell after adjustment by a relative 8%, but adjusted mortality rose by a relative 10%, compared with how patients had fared prior to launching the HRRP (JAMA Cardiol. 2018 Jan;3[1]:44-53). Recent reports from other research groups have had similar findings, such as a study of more than 3 million Medicare beneficiaries with heart failure during 2005-2015 that also showed significantly increased mortality after the penalty phase for readmissions began (JAMA. 2018 Dec 25;320[24]:2542-52). In a commentary that accompanied this report, Dr. Fonarow cited the multiple analyses that show consistent findings and the need for CMS to “initiate an expeditious reconsideration and revision” of their current approach to penalizing hospitals for heart failure readmissions (JAMA. 2018 Dec 25;320[24]:2539-41).
The groups recently in discussion with CMS about this issue include the American College of Cardiology, the American Heart Association, the Heart Failure Society of America, the American College of Physicians, the American Hospital Association, and several other medical professional groups, said Biykem Bozkurt, MD, who has worked with Dr. Fonarow and representatives from these organizations in talks with CMS.
“We are trying to find a harmonized approach with patient-centric outcomes that reflect true improvements in quality of care,” she said in an interview. One possibility up for consideration is a combined measure of heart failure readmissions, mortality, and a patient-reported outcome. The measure would go to CMS directly from each patient’s electronic medical record, making data collection less burdensome to clinicians, said Dr. Bozkurt, professor of medicine at Baylor College of Medicine and cardiology section chief at the VA Medical Center in Houston. She expressed hope that a change in the CMS metric might happen later this year.
“CMS can’t simply stop the HRRP, so the discussion is on how to get a meaningful change. I’m increasingly optimistic, because the findings of harm [from current policies] are impossible to ignore,” Dr. Fonarow said. “There will be increasing pressure on CMS to develop a pathway to make modifications. It’s egregious to continue a policy that’s been associated with harm” to heart failure patients.
Dr. Fonarow and Dr. Bozkurt had no relevant commercial disclosures.
NEW ORLEANS – Mounting evidence shows that heart failure patient mortality increased as an unintended consequence of a Medicare program that penalizes hospitals with too many 30-day readmissions of heart failure patients. This has prompted discussions among cardiologists, Medicare officials, and other stakeholders in an attempt to modify the penalty program so it no longer considers just readmissions but instead bases penalties on broader and more nuanced measures of patient outcomes.
Staffers at the Centers for Medicare & Medicaid Services, the federal agency that manages Medicare, “said that they take this seriously and will look into it, and they are interested in next-generation measures that are more patient centered” than simply the 30-day readmission rate, Gregg C. Fonarow, MD, said in an interview at the annual meeting of the American College of Cardiology. “This is a case where there is credible evidence of increased mortality that is consistent, reproducible, and strongly associated with the penalty and cannot be otherwise explained,” said Dr. Fonarow, professor of medicine and cochief of cardiology at the University of California, Los Angeles.
He is among the most active researchers to document that, while CMS’s Hospital Readmissions Reduction Program (HRRP) led to significantly reduced readmission rates in patients with heart failure, this came at a cost of a significant increase in mortality among the same patients. For example, an article he published in 2018 that analyzed more than 115,000 Medicare beneficiaries during 2006-2014 showed that during the penalty phase, which began in 2012, readmissions fell after adjustment by a relative 8%, but adjusted mortality rose by a relative 10%, compared with how patients had fared prior to launching the HRRP (JAMA Cardiol. 2018 Jan;3[1]:44-53). Recent reports from other research groups have had similar findings, such as a study of more than 3 million Medicare beneficiaries with heart failure during 2005-2015 that also showed significantly increased mortality after the penalty phase for readmissions began (JAMA. 2018 Dec 25;320[24]:2542-52). In a commentary that accompanied this report, Dr. Fonarow cited the multiple analyses that show consistent findings and the need for CMS to “initiate an expeditious reconsideration and revision” of their current approach to penalizing hospitals for heart failure readmissions (JAMA. 2018 Dec 25;320[24]:2539-41).
The groups recently in discussion with CMS about this issue include the American College of Cardiology, the American Heart Association, the Heart Failure Society of America, the American College of Physicians, the American Hospital Association, and several other medical professional groups, said Biykem Bozkurt, MD, who has worked with Dr. Fonarow and representatives from these organizations in talks with CMS.
“We are trying to find a harmonized approach with patient-centric outcomes that reflect true improvements in quality of care,” she said in an interview. One possibility up for consideration is a combined measure of heart failure readmissions, mortality, and a patient-reported outcome. The measure would go to CMS directly from each patient’s electronic medical record, making data collection less burdensome to clinicians, said Dr. Bozkurt, professor of medicine at Baylor College of Medicine and cardiology section chief at the VA Medical Center in Houston. She expressed hope that a change in the CMS metric might happen later this year.
“CMS can’t simply stop the HRRP, so the discussion is on how to get a meaningful change. I’m increasingly optimistic, because the findings of harm [from current policies] are impossible to ignore,” Dr. Fonarow said. “There will be increasing pressure on CMS to develop a pathway to make modifications. It’s egregious to continue a policy that’s been associated with harm” to heart failure patients.
Dr. Fonarow and Dr. Bozkurt had no relevant commercial disclosures.
REPORTING FROM ACC 19
Novel percutaneous therapy for HOCM in development
SNOWMASS, COLO. – Percutaneous mitral valve plication shows early promise as a primary therapy for severely symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy (HOCM), Paul Sorajja, MD, said at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
He and his coworkers at the Minneapolis Heart Institute developed the novel procedure and published the first experience in the world with it. But further study in a much larger patient population is needed before percutaneous mitral plication is ready for prime time as a treatment for symptomatic HOCM, according to Dr. Sorajja, director of the Center of Valve and Structural Heart Disease at the institute.
Surgical myectomy is the guideline-recommended standard for treatment of patients with disabling symptoms caused by left ventricular outflow tract obstruction in the setting of hypertrophic cardiomyopathy. Alcohol septal ablation is a widely utilized alternative in patients who are frail and elderly or otherwise high-risk surgical candidates, or who lack ready access to an experienced surgical myectomy center, where the best outcomes are achieved. But roughly 20% of patients evaluated for alcohol septal ablation don’t have a septal artery anatomy amenable to the procedure. Other patients are put off by the 10%-50% risk that they will require a permanent pacemaker after alcohol septal ablation, depending upon their baseline ECG. And a small percentage of well-chosen patients – less than 10% – will experience inadequate gradient relief following alcohol septal ablation. So there is room for a novel therapeutic approach.
A percutaneous mitral clip–based solution, while technically challenging, offers several advantages over surgical myectomy and alcohol septal ablation. It’s less invasive, doesn’t create a potentially arrhythmogenic ablation scar requiring a permanent pacemaker, and it targets the mitral valve directly, addressing the mitral regurgitation that causes the left ventricular outflow tract obstruction. In contrast, both surgical myectomy and alcohol septal ablation target the ventricular septum.
Dr. Sorajja summarized his experience to date with percutaneous mitral valve plication for symptomatic HOCM, which encompasses the six patients in the published study (J Am Coll Cardiol. 2016 Jun 21;67[24]:2811-8) and the four others treated since then. The procedure was completed with placement of a single MitraClip in 9 of 10 patients. One patient experienced cardiac tamponade, resulting in a halt of the procedure; in the other nine, the intervention eliminated systolic anterior motion and markedly decreased the intraoperative left ventricular outflow tract gradient and mitral regurgitation.
At 2-5 years of follow-up, all patients have improved from New York Heart Association functional class III preprocedurally to class I or II. One patient required alcohol septal ablation. High systolic left ventricular outflow tract velocities in excess of 4 cm/s have been documented via follow-up echocardiography in some patients, the significance of which is under study.
Dr. Sorajja reported receiving research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic, and serving as a consultant to those companies and several others.
SNOWMASS, COLO. – Percutaneous mitral valve plication shows early promise as a primary therapy for severely symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy (HOCM), Paul Sorajja, MD, said at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
He and his coworkers at the Minneapolis Heart Institute developed the novel procedure and published the first experience in the world with it. But further study in a much larger patient population is needed before percutaneous mitral plication is ready for prime time as a treatment for symptomatic HOCM, according to Dr. Sorajja, director of the Center of Valve and Structural Heart Disease at the institute.
Surgical myectomy is the guideline-recommended standard for treatment of patients with disabling symptoms caused by left ventricular outflow tract obstruction in the setting of hypertrophic cardiomyopathy. Alcohol septal ablation is a widely utilized alternative in patients who are frail and elderly or otherwise high-risk surgical candidates, or who lack ready access to an experienced surgical myectomy center, where the best outcomes are achieved. But roughly 20% of patients evaluated for alcohol septal ablation don’t have a septal artery anatomy amenable to the procedure. Other patients are put off by the 10%-50% risk that they will require a permanent pacemaker after alcohol septal ablation, depending upon their baseline ECG. And a small percentage of well-chosen patients – less than 10% – will experience inadequate gradient relief following alcohol septal ablation. So there is room for a novel therapeutic approach.
A percutaneous mitral clip–based solution, while technically challenging, offers several advantages over surgical myectomy and alcohol septal ablation. It’s less invasive, doesn’t create a potentially arrhythmogenic ablation scar requiring a permanent pacemaker, and it targets the mitral valve directly, addressing the mitral regurgitation that causes the left ventricular outflow tract obstruction. In contrast, both surgical myectomy and alcohol septal ablation target the ventricular septum.
Dr. Sorajja summarized his experience to date with percutaneous mitral valve plication for symptomatic HOCM, which encompasses the six patients in the published study (J Am Coll Cardiol. 2016 Jun 21;67[24]:2811-8) and the four others treated since then. The procedure was completed with placement of a single MitraClip in 9 of 10 patients. One patient experienced cardiac tamponade, resulting in a halt of the procedure; in the other nine, the intervention eliminated systolic anterior motion and markedly decreased the intraoperative left ventricular outflow tract gradient and mitral regurgitation.
At 2-5 years of follow-up, all patients have improved from New York Heart Association functional class III preprocedurally to class I or II. One patient required alcohol septal ablation. High systolic left ventricular outflow tract velocities in excess of 4 cm/s have been documented via follow-up echocardiography in some patients, the significance of which is under study.
Dr. Sorajja reported receiving research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic, and serving as a consultant to those companies and several others.
SNOWMASS, COLO. – Percutaneous mitral valve plication shows early promise as a primary therapy for severely symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy (HOCM), Paul Sorajja, MD, said at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
He and his coworkers at the Minneapolis Heart Institute developed the novel procedure and published the first experience in the world with it. But further study in a much larger patient population is needed before percutaneous mitral plication is ready for prime time as a treatment for symptomatic HOCM, according to Dr. Sorajja, director of the Center of Valve and Structural Heart Disease at the institute.
Surgical myectomy is the guideline-recommended standard for treatment of patients with disabling symptoms caused by left ventricular outflow tract obstruction in the setting of hypertrophic cardiomyopathy. Alcohol septal ablation is a widely utilized alternative in patients who are frail and elderly or otherwise high-risk surgical candidates, or who lack ready access to an experienced surgical myectomy center, where the best outcomes are achieved. But roughly 20% of patients evaluated for alcohol septal ablation don’t have a septal artery anatomy amenable to the procedure. Other patients are put off by the 10%-50% risk that they will require a permanent pacemaker after alcohol septal ablation, depending upon their baseline ECG. And a small percentage of well-chosen patients – less than 10% – will experience inadequate gradient relief following alcohol septal ablation. So there is room for a novel therapeutic approach.
A percutaneous mitral clip–based solution, while technically challenging, offers several advantages over surgical myectomy and alcohol septal ablation. It’s less invasive, doesn’t create a potentially arrhythmogenic ablation scar requiring a permanent pacemaker, and it targets the mitral valve directly, addressing the mitral regurgitation that causes the left ventricular outflow tract obstruction. In contrast, both surgical myectomy and alcohol septal ablation target the ventricular septum.
Dr. Sorajja summarized his experience to date with percutaneous mitral valve plication for symptomatic HOCM, which encompasses the six patients in the published study (J Am Coll Cardiol. 2016 Jun 21;67[24]:2811-8) and the four others treated since then. The procedure was completed with placement of a single MitraClip in 9 of 10 patients. One patient experienced cardiac tamponade, resulting in a halt of the procedure; in the other nine, the intervention eliminated systolic anterior motion and markedly decreased the intraoperative left ventricular outflow tract gradient and mitral regurgitation.
At 2-5 years of follow-up, all patients have improved from New York Heart Association functional class III preprocedurally to class I or II. One patient required alcohol septal ablation. High systolic left ventricular outflow tract velocities in excess of 4 cm/s have been documented via follow-up echocardiography in some patients, the significance of which is under study.
Dr. Sorajja reported receiving research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic, and serving as a consultant to those companies and several others.
REPORTING FROM ACC SNOWMASS 2019
Look for alcohol septal ablation in the next HOCM guideline
SNOWMASS, COLO. – Recent data on long-term outcomes of alcohol septal ablation for hypertrophic obstructive cardiomyopathy are “quite favorable” and will be considered in the deliberations of the task force charged with revising the 2011 American College of Cardiology/American Heart Association guidelines.
Paul Sorajja, MD, a member of the task force and director of the Center of Valve and Structural Heart Disease at the Minneapolis Heart Institute, explained that the 2011 ACC/AHA guidelines on hypertrophic cardiomyopathy took an appropriately cautious stance regarding alcohol septal ablation (ASA) in light of a 2010 Dutch report warning of an increased risk of sudden cardiac death following the procedure (Circ Heart Fail. 2010 May;3[3]:362-9) and a dearth of evidence to the contrary.
The 2011 guidelines recommend surgical myectomy performed in an experienced center as the class I treatment of choice for patients with severely symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy (HOCM). ASA gets a class IIa recommendation for patients at high surgical risk, and is class III – meaning don’t do it – for patients under age 40 years if myectomy is a viable option (J Am Coll Cardiol. 2011 Dec 13;58[25]:e212-60), Dr. Sorajja noted at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
However, the cautionary Dutch study that influenced the 2011 guidelines is considered controversial, he explained. It was small – just 91 patients – and the operators used twice the normal volume of alcohol, with a resultant much larger, potentially arrhythmogenic myocardial ablation scar. So, many experts have been eagerly awaiting additional long-term studies. And that long-sought data has recently been piling up. Since the 2011 guidelines, six long-term studies have been published, including one led by Dr. Sorajja (Circulation. 2012 Nov 13;126[20]:2374-80). The results have been consistently favorable, with 5-year survival rates of 87%-96%, in line with rates in the general population.
The largest of these studies included 1,197 patients who underwent ASA at seven centers in four European countries. The 30-day mortality and pacemaker implantation rates were significantly lower in patients aged up to 50 years, compared with those aged 65 and up. The annual mortality rate during a mean follow-up of 5.4 years was 1% in patients age 50 years and younger, 2.1% in those aged 51-64, and 5.1% in the oldest group. Arrhythmic events occurred at a rate of about 1% per year in all three age groups. And 95% of patients in the youngest group were in New York Heart Association class I or II at last follow-up (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1134-43).
In an accompanying editorial, Michael A. Fifer, MD, of Massachusetts General Hospital, Boston, commented that “high-volume surgical myectomy centers are few and far between” and there is “a clear inverse relation between [surgical] procedure volume and outcomes.”
The study “provides the most robust data to date regarding the outcomes of ASA in younger patients, precisely the type of data that were missing at the time of writing of the ACCF/AHA and European Society of Cardiology guidelines. Given the favorable outcomes of ASA in this age group, and the unavailability of high-volume myectomy programs in many geographic regions, the time has come to liberalize the indication for ASA in younger patients,” declared Dr. Fifer (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1144-6).
The second-largest long-term study of ASA was a recent report on 952 German patients with a minimum 6-year follow-up. The estimated 5-, 10-, and 15-year survival rates were 95.8%, 88.3%, and 79.7%, respectively. Estimated survival free of cardiac events was 98.9% at 5 years, 97.0% at 10 years, and 96.5% at 15 years. About 5% of patients received an implantable cardioverter defibrillator.
The investigators concluded, “In this study, PTSMA [percutaneous transluminal septal myocardial ablation] could be proofed as a safe procedure with ongoing symptomatic improvement and excellent long-term survival. Therefore, PTSMA is a reasonable alternative to surgical myectomy in HOCM.” (J Am Coll Cardiol. 2018 Dec 18;72[24]:3087-94) It’s way too early in the ACC/AHA guideline revision process to say what the new recommendations will be, according to Dr. Sorajja.
One unsettled issue, in his view, is whether ASA outcomes are significantly better in high-volume centers. A study of all 11,248 patients who underwent surgical myectomy of ASA during 2003-2011 in a large U.S. inpatient database concluded that undergoing surgical myectomy in a bottom-tertile-volume hospital was independently associated with an adjusted 210% increased risk of inpatient all-cause mortality and a 280% increased risk of bleeding, but that being in the lowest tertile of ASA hospital volume wasn’t independently associated with increased risk after adjustment for potential confounders (JAMA Cardiol. 2016 Jun 1;1:[3]:324-32).
However, Dr. Sorajja indicated he didn’t find the statistically adjusted results in the ASA cohort persuasive.
“I will tell you that the favorable results in the long-term studies came from hospitals in the highest-volume tertile,” the cardiologist said.
At present, he considers surgical myectomy the gold standard therapy. With well-selected patients for ASA – that is, those for whom imaging has identified an appropriate septal artery for delivery of the alcohol, along with no more than 24 mm of septal hypertrophy so the alcohol dose can be limited to a maximum of 20-25 cc – it’s reasonable to expect gradient relief in more than 90% of patients, surgical-like results with optimal relief of left ventricular outflow tract obstruction and a residual gradient of less than 10 mm Hg in about 75%, and a procedural mortality of about 1%, he said.
Dr. Sorajja reported receiving research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic, and serving as a consultant to those companies and several others.
SNOWMASS, COLO. – Recent data on long-term outcomes of alcohol septal ablation for hypertrophic obstructive cardiomyopathy are “quite favorable” and will be considered in the deliberations of the task force charged with revising the 2011 American College of Cardiology/American Heart Association guidelines.
Paul Sorajja, MD, a member of the task force and director of the Center of Valve and Structural Heart Disease at the Minneapolis Heart Institute, explained that the 2011 ACC/AHA guidelines on hypertrophic cardiomyopathy took an appropriately cautious stance regarding alcohol septal ablation (ASA) in light of a 2010 Dutch report warning of an increased risk of sudden cardiac death following the procedure (Circ Heart Fail. 2010 May;3[3]:362-9) and a dearth of evidence to the contrary.
The 2011 guidelines recommend surgical myectomy performed in an experienced center as the class I treatment of choice for patients with severely symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy (HOCM). ASA gets a class IIa recommendation for patients at high surgical risk, and is class III – meaning don’t do it – for patients under age 40 years if myectomy is a viable option (J Am Coll Cardiol. 2011 Dec 13;58[25]:e212-60), Dr. Sorajja noted at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
However, the cautionary Dutch study that influenced the 2011 guidelines is considered controversial, he explained. It was small – just 91 patients – and the operators used twice the normal volume of alcohol, with a resultant much larger, potentially arrhythmogenic myocardial ablation scar. So, many experts have been eagerly awaiting additional long-term studies. And that long-sought data has recently been piling up. Since the 2011 guidelines, six long-term studies have been published, including one led by Dr. Sorajja (Circulation. 2012 Nov 13;126[20]:2374-80). The results have been consistently favorable, with 5-year survival rates of 87%-96%, in line with rates in the general population.
The largest of these studies included 1,197 patients who underwent ASA at seven centers in four European countries. The 30-day mortality and pacemaker implantation rates were significantly lower in patients aged up to 50 years, compared with those aged 65 and up. The annual mortality rate during a mean follow-up of 5.4 years was 1% in patients age 50 years and younger, 2.1% in those aged 51-64, and 5.1% in the oldest group. Arrhythmic events occurred at a rate of about 1% per year in all three age groups. And 95% of patients in the youngest group were in New York Heart Association class I or II at last follow-up (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1134-43).
In an accompanying editorial, Michael A. Fifer, MD, of Massachusetts General Hospital, Boston, commented that “high-volume surgical myectomy centers are few and far between” and there is “a clear inverse relation between [surgical] procedure volume and outcomes.”
The study “provides the most robust data to date regarding the outcomes of ASA in younger patients, precisely the type of data that were missing at the time of writing of the ACCF/AHA and European Society of Cardiology guidelines. Given the favorable outcomes of ASA in this age group, and the unavailability of high-volume myectomy programs in many geographic regions, the time has come to liberalize the indication for ASA in younger patients,” declared Dr. Fifer (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1144-6).
The second-largest long-term study of ASA was a recent report on 952 German patients with a minimum 6-year follow-up. The estimated 5-, 10-, and 15-year survival rates were 95.8%, 88.3%, and 79.7%, respectively. Estimated survival free of cardiac events was 98.9% at 5 years, 97.0% at 10 years, and 96.5% at 15 years. About 5% of patients received an implantable cardioverter defibrillator.
The investigators concluded, “In this study, PTSMA [percutaneous transluminal septal myocardial ablation] could be proofed as a safe procedure with ongoing symptomatic improvement and excellent long-term survival. Therefore, PTSMA is a reasonable alternative to surgical myectomy in HOCM.” (J Am Coll Cardiol. 2018 Dec 18;72[24]:3087-94) It’s way too early in the ACC/AHA guideline revision process to say what the new recommendations will be, according to Dr. Sorajja.
One unsettled issue, in his view, is whether ASA outcomes are significantly better in high-volume centers. A study of all 11,248 patients who underwent surgical myectomy of ASA during 2003-2011 in a large U.S. inpatient database concluded that undergoing surgical myectomy in a bottom-tertile-volume hospital was independently associated with an adjusted 210% increased risk of inpatient all-cause mortality and a 280% increased risk of bleeding, but that being in the lowest tertile of ASA hospital volume wasn’t independently associated with increased risk after adjustment for potential confounders (JAMA Cardiol. 2016 Jun 1;1:[3]:324-32).
However, Dr. Sorajja indicated he didn’t find the statistically adjusted results in the ASA cohort persuasive.
“I will tell you that the favorable results in the long-term studies came from hospitals in the highest-volume tertile,” the cardiologist said.
At present, he considers surgical myectomy the gold standard therapy. With well-selected patients for ASA – that is, those for whom imaging has identified an appropriate septal artery for delivery of the alcohol, along with no more than 24 mm of septal hypertrophy so the alcohol dose can be limited to a maximum of 20-25 cc – it’s reasonable to expect gradient relief in more than 90% of patients, surgical-like results with optimal relief of left ventricular outflow tract obstruction and a residual gradient of less than 10 mm Hg in about 75%, and a procedural mortality of about 1%, he said.
Dr. Sorajja reported receiving research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic, and serving as a consultant to those companies and several others.
SNOWMASS, COLO. – Recent data on long-term outcomes of alcohol septal ablation for hypertrophic obstructive cardiomyopathy are “quite favorable” and will be considered in the deliberations of the task force charged with revising the 2011 American College of Cardiology/American Heart Association guidelines.
Paul Sorajja, MD, a member of the task force and director of the Center of Valve and Structural Heart Disease at the Minneapolis Heart Institute, explained that the 2011 ACC/AHA guidelines on hypertrophic cardiomyopathy took an appropriately cautious stance regarding alcohol septal ablation (ASA) in light of a 2010 Dutch report warning of an increased risk of sudden cardiac death following the procedure (Circ Heart Fail. 2010 May;3[3]:362-9) and a dearth of evidence to the contrary.
The 2011 guidelines recommend surgical myectomy performed in an experienced center as the class I treatment of choice for patients with severely symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy (HOCM). ASA gets a class IIa recommendation for patients at high surgical risk, and is class III – meaning don’t do it – for patients under age 40 years if myectomy is a viable option (J Am Coll Cardiol. 2011 Dec 13;58[25]:e212-60), Dr. Sorajja noted at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
However, the cautionary Dutch study that influenced the 2011 guidelines is considered controversial, he explained. It was small – just 91 patients – and the operators used twice the normal volume of alcohol, with a resultant much larger, potentially arrhythmogenic myocardial ablation scar. So, many experts have been eagerly awaiting additional long-term studies. And that long-sought data has recently been piling up. Since the 2011 guidelines, six long-term studies have been published, including one led by Dr. Sorajja (Circulation. 2012 Nov 13;126[20]:2374-80). The results have been consistently favorable, with 5-year survival rates of 87%-96%, in line with rates in the general population.
The largest of these studies included 1,197 patients who underwent ASA at seven centers in four European countries. The 30-day mortality and pacemaker implantation rates were significantly lower in patients aged up to 50 years, compared with those aged 65 and up. The annual mortality rate during a mean follow-up of 5.4 years was 1% in patients age 50 years and younger, 2.1% in those aged 51-64, and 5.1% in the oldest group. Arrhythmic events occurred at a rate of about 1% per year in all three age groups. And 95% of patients in the youngest group were in New York Heart Association class I or II at last follow-up (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1134-43).
In an accompanying editorial, Michael A. Fifer, MD, of Massachusetts General Hospital, Boston, commented that “high-volume surgical myectomy centers are few and far between” and there is “a clear inverse relation between [surgical] procedure volume and outcomes.”
The study “provides the most robust data to date regarding the outcomes of ASA in younger patients, precisely the type of data that were missing at the time of writing of the ACCF/AHA and European Society of Cardiology guidelines. Given the favorable outcomes of ASA in this age group, and the unavailability of high-volume myectomy programs in many geographic regions, the time has come to liberalize the indication for ASA in younger patients,” declared Dr. Fifer (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1144-6).
The second-largest long-term study of ASA was a recent report on 952 German patients with a minimum 6-year follow-up. The estimated 5-, 10-, and 15-year survival rates were 95.8%, 88.3%, and 79.7%, respectively. Estimated survival free of cardiac events was 98.9% at 5 years, 97.0% at 10 years, and 96.5% at 15 years. About 5% of patients received an implantable cardioverter defibrillator.
The investigators concluded, “In this study, PTSMA [percutaneous transluminal septal myocardial ablation] could be proofed as a safe procedure with ongoing symptomatic improvement and excellent long-term survival. Therefore, PTSMA is a reasonable alternative to surgical myectomy in HOCM.” (J Am Coll Cardiol. 2018 Dec 18;72[24]:3087-94) It’s way too early in the ACC/AHA guideline revision process to say what the new recommendations will be, according to Dr. Sorajja.
One unsettled issue, in his view, is whether ASA outcomes are significantly better in high-volume centers. A study of all 11,248 patients who underwent surgical myectomy of ASA during 2003-2011 in a large U.S. inpatient database concluded that undergoing surgical myectomy in a bottom-tertile-volume hospital was independently associated with an adjusted 210% increased risk of inpatient all-cause mortality and a 280% increased risk of bleeding, but that being in the lowest tertile of ASA hospital volume wasn’t independently associated with increased risk after adjustment for potential confounders (JAMA Cardiol. 2016 Jun 1;1:[3]:324-32).
However, Dr. Sorajja indicated he didn’t find the statistically adjusted results in the ASA cohort persuasive.
“I will tell you that the favorable results in the long-term studies came from hospitals in the highest-volume tertile,” the cardiologist said.
At present, he considers surgical myectomy the gold standard therapy. With well-selected patients for ASA – that is, those for whom imaging has identified an appropriate septal artery for delivery of the alcohol, along with no more than 24 mm of septal hypertrophy so the alcohol dose can be limited to a maximum of 20-25 cc – it’s reasonable to expect gradient relief in more than 90% of patients, surgical-like results with optimal relief of left ventricular outflow tract obstruction and a residual gradient of less than 10 mm Hg in about 75%, and a procedural mortality of about 1%, he said.
Dr. Sorajja reported receiving research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic, and serving as a consultant to those companies and several others.
EXPERT ANALYSIS FROM ACC SNOWMASS 2019
30-day readmissions after STEMI with cardiogenic shock 13%
WASHINGTON – and remain in hospital for an average of 6 days, according to an analysis from the National Readmission Database presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.
“About one in four of the readmissions was for heart failure,” reported Karan Sud, MD, a cardiology resident at the Mount Sinai St. Luke’s West Hospital, New York.
Despite gains in acute survival among STEMI patients in cardiogenic shock, little attention has been paid to the risk of readmissions, according to Dr. Sud. According to data collected from the National Readmissions Database for 2010-2014, these rates are high enough to deserve attention, he said.
“Our goal is now to develop a scoring system based on our predictive model to identify patients at the index admission who are at risk for readmission,” Dr. Sud reported. On the basis of these predictors, it might be possible to implement strategies to optimize management and improve access to care.
In the years studied, there were 94,991 patients with STEMI and cardiogenic shock captured in the National Readmissions Database, of whom 43,205 survived and were followed for readmission. Of the 5,503 readmissions within 30 days, 12% were considered unplanned.
Half of the readmissions were for noncardiovascular causes, including sepsis, respiratory failure, and major bleeding. Of those related to cardiovascular disease, about half, or nearly 25% of the total, were for heart failure.
The predictors of readmission included female sex, age older than 75 years, average length of stay longer than 10 days, and more than three comorbidities, such as diabetes or chronic kidney disease, according to Dr. Sud.
“Those sent home from the index admission were more likely than those discharged to an extended care facility to be readmitted,” he added. He also noted that lower socioeconomic status was a risk factor for readmission, a phenomenon that he attributed to access issues regarding follow-up care.
“We are now conducting a prospective study to look at readmissions at 6 months,” reported Dr. Sud, who believes that efforts to understand the risk of readmission following STEMI complicated by cardiogenic shock might uncover opportunities for better management.
WASHINGTON – and remain in hospital for an average of 6 days, according to an analysis from the National Readmission Database presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.
“About one in four of the readmissions was for heart failure,” reported Karan Sud, MD, a cardiology resident at the Mount Sinai St. Luke’s West Hospital, New York.
Despite gains in acute survival among STEMI patients in cardiogenic shock, little attention has been paid to the risk of readmissions, according to Dr. Sud. According to data collected from the National Readmissions Database for 2010-2014, these rates are high enough to deserve attention, he said.
“Our goal is now to develop a scoring system based on our predictive model to identify patients at the index admission who are at risk for readmission,” Dr. Sud reported. On the basis of these predictors, it might be possible to implement strategies to optimize management and improve access to care.
In the years studied, there were 94,991 patients with STEMI and cardiogenic shock captured in the National Readmissions Database, of whom 43,205 survived and were followed for readmission. Of the 5,503 readmissions within 30 days, 12% were considered unplanned.
Half of the readmissions were for noncardiovascular causes, including sepsis, respiratory failure, and major bleeding. Of those related to cardiovascular disease, about half, or nearly 25% of the total, were for heart failure.
The predictors of readmission included female sex, age older than 75 years, average length of stay longer than 10 days, and more than three comorbidities, such as diabetes or chronic kidney disease, according to Dr. Sud.
“Those sent home from the index admission were more likely than those discharged to an extended care facility to be readmitted,” he added. He also noted that lower socioeconomic status was a risk factor for readmission, a phenomenon that he attributed to access issues regarding follow-up care.
“We are now conducting a prospective study to look at readmissions at 6 months,” reported Dr. Sud, who believes that efforts to understand the risk of readmission following STEMI complicated by cardiogenic shock might uncover opportunities for better management.
WASHINGTON – and remain in hospital for an average of 6 days, according to an analysis from the National Readmission Database presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.
“About one in four of the readmissions was for heart failure,” reported Karan Sud, MD, a cardiology resident at the Mount Sinai St. Luke’s West Hospital, New York.
Despite gains in acute survival among STEMI patients in cardiogenic shock, little attention has been paid to the risk of readmissions, according to Dr. Sud. According to data collected from the National Readmissions Database for 2010-2014, these rates are high enough to deserve attention, he said.
“Our goal is now to develop a scoring system based on our predictive model to identify patients at the index admission who are at risk for readmission,” Dr. Sud reported. On the basis of these predictors, it might be possible to implement strategies to optimize management and improve access to care.
In the years studied, there were 94,991 patients with STEMI and cardiogenic shock captured in the National Readmissions Database, of whom 43,205 survived and were followed for readmission. Of the 5,503 readmissions within 30 days, 12% were considered unplanned.
Half of the readmissions were for noncardiovascular causes, including sepsis, respiratory failure, and major bleeding. Of those related to cardiovascular disease, about half, or nearly 25% of the total, were for heart failure.
The predictors of readmission included female sex, age older than 75 years, average length of stay longer than 10 days, and more than three comorbidities, such as diabetes or chronic kidney disease, according to Dr. Sud.
“Those sent home from the index admission were more likely than those discharged to an extended care facility to be readmitted,” he added. He also noted that lower socioeconomic status was a risk factor for readmission, a phenomenon that he attributed to access issues regarding follow-up care.
“We are now conducting a prospective study to look at readmissions at 6 months,” reported Dr. Sud, who believes that efforts to understand the risk of readmission following STEMI complicated by cardiogenic shock might uncover opportunities for better management.
REPORTING FROM CRT 2019
FDA: Programmable heart failure device approved
. Specifically, these patients are unsuited for other treatments, have marked physical limitations related to their heart failure, and have remained symptomatic despite optimal medical therapy. They also have a regular heart rhythm, are not candidates for resynchronization, and possess a left ventricular ejection fraction of 25%-45%.
The cardiac contractility modulation system is indicated to improve 6-minute hall walk distance, quality of life, and functional status in these patients.
The system is made up of several components, including the implantable pulse generator, a programmer, and software. The pulse generator is connected to three leads that have been implanted in the heart, after which the device is tested and programmed to deliver pulses during normal heartbeats, which improves the heart’s squeezing capability. In randomized, multicenter clinical trials, the system plus optimal medical therapy demonstrated improvements in distance during 6-minute walking tests and standard assessments of heart failure symptoms when compared with optimal medical therapy alone.
The Breakthrough Device designation means this system treats a life-threatening disease and addresses unmet medical needs among some patients. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Bram Zuckerman, MD, the director of the division of cardiovascular devices in the FDA’s Center for Devices and Radiological Health said in a news release from the agency.
. Specifically, these patients are unsuited for other treatments, have marked physical limitations related to their heart failure, and have remained symptomatic despite optimal medical therapy. They also have a regular heart rhythm, are not candidates for resynchronization, and possess a left ventricular ejection fraction of 25%-45%.
The cardiac contractility modulation system is indicated to improve 6-minute hall walk distance, quality of life, and functional status in these patients.
The system is made up of several components, including the implantable pulse generator, a programmer, and software. The pulse generator is connected to three leads that have been implanted in the heart, after which the device is tested and programmed to deliver pulses during normal heartbeats, which improves the heart’s squeezing capability. In randomized, multicenter clinical trials, the system plus optimal medical therapy demonstrated improvements in distance during 6-minute walking tests and standard assessments of heart failure symptoms when compared with optimal medical therapy alone.
The Breakthrough Device designation means this system treats a life-threatening disease and addresses unmet medical needs among some patients. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Bram Zuckerman, MD, the director of the division of cardiovascular devices in the FDA’s Center for Devices and Radiological Health said in a news release from the agency.
. Specifically, these patients are unsuited for other treatments, have marked physical limitations related to their heart failure, and have remained symptomatic despite optimal medical therapy. They also have a regular heart rhythm, are not candidates for resynchronization, and possess a left ventricular ejection fraction of 25%-45%.
The cardiac contractility modulation system is indicated to improve 6-minute hall walk distance, quality of life, and functional status in these patients.
The system is made up of several components, including the implantable pulse generator, a programmer, and software. The pulse generator is connected to three leads that have been implanted in the heart, after which the device is tested and programmed to deliver pulses during normal heartbeats, which improves the heart’s squeezing capability. In randomized, multicenter clinical trials, the system plus optimal medical therapy demonstrated improvements in distance during 6-minute walking tests and standard assessments of heart failure symptoms when compared with optimal medical therapy alone.
The Breakthrough Device designation means this system treats a life-threatening disease and addresses unmet medical needs among some patients. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Bram Zuckerman, MD, the director of the division of cardiovascular devices in the FDA’s Center for Devices and Radiological Health said in a news release from the agency.
MitraClip improves survival and health status for at least 2 years
, based on results from a substudy of the COAPT trial.
Significant improvements seen at 1 month in the TMVr group had waned only slightly by the 2-year time point, reported lead author Suzanne V. Arnold, MD, of Saint Luke’s Mid America Heart Institute and University of Missouri–Kansas City, who presented the findings at the annual meeting of the American College of Cardiology. The study was simultaneously published in the Journal of the American College of Cardiology.
“Considering the previously reported benefits of TMVr on survival and heart failure hospitalization, these health status findings further support the device as a valuable treatment option for heart failure patients with severe secondary mitral regurgitation who remain symptomatic despite maximally-tolerated guideline-directed medical therapy,” Dr. Arnold and her colleagues concluded.
Primary findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial showed that TMVr reduced hospitalizations due to heart failure and all-cause mortality over 2 years, leading the Food and Drug Administration to grant an extended indication to MitraClip. With the present substudy, the investigators sought to learn more about impacts of TMVr on overall health.
“Beyond prolonging survival and reducing hospitalizations, improving patients’ health status (i.e., symptoms, functional status, quality of life) is a key treatment goal of TMVr,” the investigators wrote. “In fact, among older patients with comorbidities and high symptom burden, health status improvement may be of greater importance to patients than improved survival.”
To measure these outcomes, the investigators employed the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey, which they administered to 302 patients in the TMVr group and 312 patients in the standard care group. The primary endpoint was the KCCQ overall summary score (KCCQ-OS), which ranges from 0 to 100, with higher scores indicating better health status.
Across all patients, the average baseline KCCQ-OS score was 52.4 ± 23.0. After 1 month, the average KCCQ-OS score rose 2.1 points in the standard care group, while the TMVr group saw a 16.9-point increase, most heavily through the questionnaire’s quality of life domain. These figures translate to a mean between-group difference of 15.9 points, a value that decreased only slightly after 2 years, to 12.8 points. Further suggesting that TMVr had beneficial and lasting effects, a significantly greater percentage of patients in the TMVr group than in the standard care group were alive with a moderately large health improvement after 2 years (36.4% vs 16.6%; P less than .001).
The study was funded by Abbott Vascular. Several of the investigators reported financial relationships with Abbott as well as Novartis, Bayer, V-wave, Corvia, and others.
SOURCE: Arnold et al. J Am Coll Cardiol. 2019 Mar 17.
, based on results from a substudy of the COAPT trial.
Significant improvements seen at 1 month in the TMVr group had waned only slightly by the 2-year time point, reported lead author Suzanne V. Arnold, MD, of Saint Luke’s Mid America Heart Institute and University of Missouri–Kansas City, who presented the findings at the annual meeting of the American College of Cardiology. The study was simultaneously published in the Journal of the American College of Cardiology.
“Considering the previously reported benefits of TMVr on survival and heart failure hospitalization, these health status findings further support the device as a valuable treatment option for heart failure patients with severe secondary mitral regurgitation who remain symptomatic despite maximally-tolerated guideline-directed medical therapy,” Dr. Arnold and her colleagues concluded.
Primary findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial showed that TMVr reduced hospitalizations due to heart failure and all-cause mortality over 2 years, leading the Food and Drug Administration to grant an extended indication to MitraClip. With the present substudy, the investigators sought to learn more about impacts of TMVr on overall health.
“Beyond prolonging survival and reducing hospitalizations, improving patients’ health status (i.e., symptoms, functional status, quality of life) is a key treatment goal of TMVr,” the investigators wrote. “In fact, among older patients with comorbidities and high symptom burden, health status improvement may be of greater importance to patients than improved survival.”
To measure these outcomes, the investigators employed the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey, which they administered to 302 patients in the TMVr group and 312 patients in the standard care group. The primary endpoint was the KCCQ overall summary score (KCCQ-OS), which ranges from 0 to 100, with higher scores indicating better health status.
Across all patients, the average baseline KCCQ-OS score was 52.4 ± 23.0. After 1 month, the average KCCQ-OS score rose 2.1 points in the standard care group, while the TMVr group saw a 16.9-point increase, most heavily through the questionnaire’s quality of life domain. These figures translate to a mean between-group difference of 15.9 points, a value that decreased only slightly after 2 years, to 12.8 points. Further suggesting that TMVr had beneficial and lasting effects, a significantly greater percentage of patients in the TMVr group than in the standard care group were alive with a moderately large health improvement after 2 years (36.4% vs 16.6%; P less than .001).
The study was funded by Abbott Vascular. Several of the investigators reported financial relationships with Abbott as well as Novartis, Bayer, V-wave, Corvia, and others.
SOURCE: Arnold et al. J Am Coll Cardiol. 2019 Mar 17.
, based on results from a substudy of the COAPT trial.
Significant improvements seen at 1 month in the TMVr group had waned only slightly by the 2-year time point, reported lead author Suzanne V. Arnold, MD, of Saint Luke’s Mid America Heart Institute and University of Missouri–Kansas City, who presented the findings at the annual meeting of the American College of Cardiology. The study was simultaneously published in the Journal of the American College of Cardiology.
“Considering the previously reported benefits of TMVr on survival and heart failure hospitalization, these health status findings further support the device as a valuable treatment option for heart failure patients with severe secondary mitral regurgitation who remain symptomatic despite maximally-tolerated guideline-directed medical therapy,” Dr. Arnold and her colleagues concluded.
Primary findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial showed that TMVr reduced hospitalizations due to heart failure and all-cause mortality over 2 years, leading the Food and Drug Administration to grant an extended indication to MitraClip. With the present substudy, the investigators sought to learn more about impacts of TMVr on overall health.
“Beyond prolonging survival and reducing hospitalizations, improving patients’ health status (i.e., symptoms, functional status, quality of life) is a key treatment goal of TMVr,” the investigators wrote. “In fact, among older patients with comorbidities and high symptom burden, health status improvement may be of greater importance to patients than improved survival.”
To measure these outcomes, the investigators employed the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey, which they administered to 302 patients in the TMVr group and 312 patients in the standard care group. The primary endpoint was the KCCQ overall summary score (KCCQ-OS), which ranges from 0 to 100, with higher scores indicating better health status.
Across all patients, the average baseline KCCQ-OS score was 52.4 ± 23.0. After 1 month, the average KCCQ-OS score rose 2.1 points in the standard care group, while the TMVr group saw a 16.9-point increase, most heavily through the questionnaire’s quality of life domain. These figures translate to a mean between-group difference of 15.9 points, a value that decreased only slightly after 2 years, to 12.8 points. Further suggesting that TMVr had beneficial and lasting effects, a significantly greater percentage of patients in the TMVr group than in the standard care group were alive with a moderately large health improvement after 2 years (36.4% vs 16.6%; P less than .001).
The study was funded by Abbott Vascular. Several of the investigators reported financial relationships with Abbott as well as Novartis, Bayer, V-wave, Corvia, and others.
SOURCE: Arnold et al. J Am Coll Cardiol. 2019 Mar 17.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY