Tag: Cardiology

Novel cholesterol removal strategy shows potential benefits post-heart attack

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The first trial of a novel strategy for removing cholesterol from patients’ arteries did not reduce the risk of death, heart attack or stroke within three months of a prior heart attack, according to research presented at the American College of Cardiology’s Annual Scientific Session. However, the findings suggest that the strategy may be beneficial with longer follow-up.

We did not see a statistically significant reduction in the primary endpoint of risk for death, a heart attack or a stroke at 90 days, or a reduction in risk for stroke at any time.”

C. Michael Gibson, MD, professor of medicine at Harvard Medical School and study’s lead author

However, in an exploratory analysis of outcomes, treated patients had fewer heart attacks and heart-attack deaths than patients in the control group at six months, he said.

“Although we missed our primary endpoint, our data support the hypothesis that HDL cholesterol plays a role in reducing subsequent coronary plaque disruption events like heart attack via enhanced cholesterol efflux attacks,” Gibson said.

People who have had a heart attack are at high risk for another one, especially during the next 90 days, Gibson said. This study was the first in which patients received an infusion of ApoA-I, a component of HDL (“good”) cholesterol, shortly after a heart attack, with the aim of stabilizing coronary plaque and reducing adverse cardiovascular events. The investigational drug CSL112 used in the study is a form of ApoA-I that’s extracted from human plasma, the liquid component of blood.

High levels of LDL cholesterol create a build-up of plaque in the arteries that carry blood to the heart, increasing risk for an arterial blockage that causes a heart attack. HDL cholesterol removes cholesterol from the arteries and carries it to the liver, which then excretes it. ApoA-I, the main component of HDL cholesterol, helps initiate the process of removing cholesterol from the body. A previous study showed that a single infusion of CSL112 reduced the amount of LDL cholesterol in arterial plaque by as much as 50%.

Other studies have shown that high levels of HDL cholesterol are associated with reduced heart attack risk. Recent research, however, suggests that the level of HDL cholesterol number may be less important for reducing heart attack risk than how well it performs at removing cholesterol, Gibson said.

“We know that in the setting of a heart attack, when the HDL cholesterol is good at getting a lot of cholesterol out of the arteries, that results in better outcomes for patients,” he said.

Gibson and his colleagues hypothesized that infusions of CSL112 given shortly after a heart attack might—by boosting the body’s ability to dispose of cholesterol—reduce patients’ risk for a repeat heart attack during the next crucial 90 days. The international AEGIS-II trial, conducted in 49 countries, was designed to test this hypothesis.

The study enrolled 18,219 patients (median age 65.5 years, 74% men and 84.5% White) who had been hospitalized for a heart attack and had multiple blockages in arteries carrying blood to the heart that elevated their risk for another heart attack. They also had other risk factors, including having had a previous heart attack, receiving drug treatment for diabetes or being 65 or older. Patients were randomly assigned to receive infusions of either CSL112 or a placebo for four weeks, with the first infusion given within five days of hospitalization.

The study’s primary endpoint was the time to the first occurrence of a major adverse cardiovascular event (MACE; i.e., heart attack, stroke or death due to heart disease or a stroke) at 90 days. Secondary endpoints included the time to the first occurrence of a MACE within six months and one year and of each specific event within 90 days, six months and one year.

At 90 days, patients treated with CSL112 had a 4.8% reduction in risk for death, heart attack or stroke compared with 5.2% for those treated with a placebo, a difference that was not statistically significant. In an exploratory analysis, however, patients treated with CSL112 were 14% less likely to have or die from a heart attack at 180 days. In addition, patients treated with CSL112 were 32% less likely to have a heart attack caused by a blood clot in a stent (a tiny mesh tube inserted into an artery to prevent it from becoming blocked) at 90 days and 29% less likely at 180 days.

Another potentially important finding, Gibson said, is that patients whose LDL cholesterol level was 100 mg/dL or higher at study entry experienced a 30% decrease in the primary endpoint, a statistically significant finding, whereas patients whose LDL cholesterol at study entry was less than 100 mg/dL saw no decrease in the primary endpoint.

“Baseline LDL modulated the treatment effect,” Gibson said.

“Overall, our findings are consistent with ApoA-I having a role in stabilizing heart blockages and reducing the risk of a blockage that ruptures and causing a heart attack further out than 90 days,” Gibson said. “It’s plausible that by giving ApoA-1 to clear the cholesterol out of the body and then treating the patient with cholesterol-lowering medications to keep LDL cholesterol levels low, we could see reductions in deaths and heart attacks that continue over time.”

Future research will focus on identifying high-risk patients who might benefit from this approach, he said.

An antiplatelet effect of CSL112 or a reduction of cholesterol in the arteries resulting from treatment with CSL112 could also explain the significant reduction in the number of heart attacks caused by a blood clot in a stent, he said. The reason strokes were not reduced may be that strokes can be caused by mechanisms other than the rupture of arterial blockages, he said.

A limitation of the study is that women, Black people and people of Asian heritage were underrepresented, which could reduce the findings’ generalizability, Gibson said.

The study was funded by CSL Behring, the manufacturer of CSL112.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation. The findings of the exploratory analysis were/will be published in the Journal of the American College of Cardiology.

Gibson will be available to the media in a press conference on Saturday, April 6, 2024, at 10:45 a.m. ET / 14:45 UTC in Room B203.

Gibson will present the study, “Patients With Acute Myocardial Infarction (ApoA-I Event Reducing In Ischemic Syndromes II (AEGIS-II) Trial): Primary Trial Results,” on Saturday, April 6, 2024, at 9:30 a.m. ET / 13:30 UTC in the Hall B-1 Main Tent.

Source:

American College of Cardiology

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April 8, 2024
Empagliflozin shows mixed results in heart attack patients

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Use of the sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin following a heart attack did not show a significant benefit in reducing overall heart failure hospitalizations or death from any cause, according to a study presented at the American College of Cardiology’s Annual Scientific Session. However, researchers said the drug may be helpful in reducing heart failure risks, including hospitalization, following a heart attack.

Despite falling short of its primary endpoint, results from the EMPACT-MI trial found that people who took empagliflozin had a significantly lower risk of certain outcomes directly related to heart failure, including first hospitalization for heart failure, total hospitalization for heart failure and a composite of heart failure hospitalization and death from heart failure, without any increased risk of adverse events.

We found that empagliflozin did not reduce mortality after a heart attack but did reduce the risk of heart failure after heart attack. To have a 25% to 30% reduction in heart failure hospitalizations is pretty clinically meaningful, but if you put it together with all-cause mortality, it was not a positive study for our primary endpoint.”

Javed Butler, MD, president of the Baylor Scott and White Research Institute in Dallas, distinguished professor of medicine at the University of Mississippi in Jackson, Mississippi, and study’s lead author

SGLT-2 inhibitors were initially approved to treat Type 2 diabetes by lowering blood sugar. As evidence has mounted pointing to their benefits in reducing heart failure and other forms of heart disease, researchers have sought to determine whether these drugs could help to prevent heart failure even in people without diabetes or chronic kidney disease.

A heart attack can damage the heart muscle in ways that sometimes lead to heart failure, a condition in which the heart becomes too weak or too stiff to effectively pump blood throughout the body. The EMPACT-MI trial was designed to determine whether SGLT-2 inhibitors could safely help to prevent heart failure and reduce mortality in people with a high risk of heart failure following a heart attack.

The study enrolled 6,522 people treated for acute myocardial infarction at 451 centers in 22 countries. Participants had no history of heart failure but had at least one heart failure risk factor in addition to signs of potential heart dysfunction as indicated by a newly lowered left ventricle ejection fraction to below 45% and/or signs or symptoms of congestion requiring treatment. About 32% had Type 2 diabetes. On average, participants were 64 years old and approximately 25% were women and 84% were White.

Within 14 days of being admitted to the hospital for a heart attack, half of the participants were randomly assigned to receive empagliflozin at a dose of 10 mg daily, while the other half received a placebo. Researchers tracked outcomes for a median of just under 18 months.

The study’s primary composite endpoint occurred in 8.2% of those who received empagliflozin and 9.1% of those receiving a placebo, a difference that was not statistically significant. There was also no difference in the rate of death from any cause, which occurred in 5.2% of those receiving empagliflozin and 5.5% of the control group.

All secondary endpoints related specifically to heart failure outcomes were significantly reduced among patients who received empagliflozin. For example, those receiving empagliflozin were 23% less likely to experience a first heart failure hospitalization and 33% less likely to experience any heart failure hospitalization—including recurrent hospitalizations—compared with those taking a placebo. The composite rate of total heart failure hospitalizations and death from heart failure was also 31% lower among those receiving empagliflozin.

Among patients who were not taking common heart failure therapies such as diuretics, angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor/neprilysin inhibitor (ARNI) at the time of their initial hospital discharge, those taking empagliflozin were significantly less likely to start such therapies within six months compared with those taking a placebo.

“In terms of heart failure outcomes, the data is not only strong, but it’s consistent with what we’ve found over the past 10 years in yet another population,” Butler said. “This finding is completely consistent in both direction and magnitude with other studies of SGLT-2 inhibitors in populations with diabetes and chronic kidney disease.”

While as a pragmatic trial design to simplify trial procedures and make it easier on both the participants and the sites, the study had limitations that may have influenced the findings, researchers said. For example, because outcomes were not adjudicated by independent reviewers, outpatient heart failure events were not formally captured as part of the primary endpoint. However, researchers said data on outpatient heart failure visits were collected as part of the study protocols for assessing adverse events. An analysis of these events showed outpatient visits for heart failure were substantially lower in participants who received empagliflozin compared with placebo.

Another limitation was the use of all-cause mortality as part of the primary endpoint, which meant that deaths unrelated to heart failure were included in the endpoint even though the study drug was unlikely to influence them. There were also some unusual circumstances that may have influenced rates of both hospitalization and death, including the COVID-19 pandemic and conflicts involving Russia, Ukraine and Israel, all countries that participated in the trial.

Finally, researchers said that the follow-up period may have been too short to fully capture any difference in mortality related to heart failure. Since people who developed heart failure following their heart attack typically did not begin to show heart failure symptoms until a few months later, any reductions in mortality would not be expected to emerge until after that.

“We just did not have long enough follow-up to see whether that heart failure prevention would lead to a benefit in mortality, but it’s a reasonable clinical thing to say that if you’re preventing heart failure, it’s a good thing,” Butler said.

The study was funded by Boehringer Ingelheim and Eli Lilly.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.

Butler will be available to the media in a press conference on Saturday, April 6, 2024, at 10:45 a.m. ET / 14:45 UTC in Room B203.

Butler will present the study, “Empagliflozin After Acute Myocardial Infarction: Results of the EMPACT-MI Trial,” on Saturday, April 6, 2024, at 9:30 a.m. ET / 13:30 UTC in the Hall B-1 Main Tent.

Source:

American College of Cardiology

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April 8, 2024
Interatrial shunt may offer differential benefits based on heart failure type

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Patients with heart failure who had a small shunt inserted between the heart’s left and right atria did not see any significant benefits overall compared with those who received a placebo procedure after a median of 22 months follow-up, in a study presented at the American College of Cardiology’s Annual Scientific Session.

The trial, called RELIEVE-HF, is the first randomized placebo-procedure controlled trial of interatrial shunting that included patients with both major types of heart failure: heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). While the trial did not meet its primary endpoint, it moves the field forward by offering signals that the benefits and risks of interatrial shunts may vary by heart failure type, according to researchers.

When you examine the outcomes in patients with heart failure across a broad range of left ventricular ejection fraction, the Ventura interatrial shunt was extremely safe but did not improve outcomes compared with no treatment. However, in a prespecified analysis, data suggest that the shunt may be beneficial in patients with HFrEF and worsen outcomes in patients with HFpEF. We believe further studies are warranted to confirm the benefits we observed in patients with reduced ejection fraction.”

Gregg Stone, MD, professor of cardiology and population health sciences at Icahn School of Medicine at Mount Sinai in New York and study’s first author

Heart failure is a condition in which the heart becomes too weak or stiff to effectively pump blood, leading to fatigue, organ damage, shortness of breath and an increased risk of life-threatening cardiovascular events. In HFrEF, the heart muscle becomes weak and does not squeeze as hard as it should. In HFpEF, the left ventricle becomes stiff and does not properly fill with blood.

The Ventura shunt is one of several interatrial devices being tested to aid in the treatment of heart failure. It is designed to form a small connection or passage between the left and right atria to allow blood to leave the left atrium—especially as left atrial pressure rises—thus reducing the pressure in the left atrium and the lungs. High left atrial pressure is a primary cause of shortness of breath and hospitalizations related to heart failure.

The trial randomized 508 patients at 94 sites in North America, Europe, Israel, Australia and New Zealand. All participants had symptomatic heart failure despite taking medications at maximally tolerated doses. About 40% of participants had HFrEF and 60% had HFpEF.

Participants were randomly assigned to undergo a procedure to insert the Ventura shunt or a placebo procedure in which a script was followed with all the same protocols to mask patients as to whether the shunt was inserted. Operators were aware of which procedure each patient received but patients, their families and the rest of the medical teams taking care of the patient after the procedure were not. Researchers tracked outcomes in each participant for at least one year and up to two years.

The results showed no significant difference between groups in terms of the trial’s primary endpoint, a hierarchical composite ranking of death from any cause; heart transplant or left ventricular assist device; heart failure hospitalizations; worsening of outpatient heart failure events; and change in quality of life, as measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). This hierarchical composite approach for assessing efficacy allows diverse types of outcomes to be incorporated in ranked fashion into an overall “win ratio” reflecting the overall outcome of a drug or device.

In a pre-planned analysis focused on heart failure type, patients with HFrEF who received the shunt were found to have improvements across all outcomes assessed (especially fewer hospitalizations for heart failure), while those with HFpEF who received the shunt were found to have increased rates of death and heart failure hospitalizations. This difference could be attributed to the greater compliance or flexibility of the heart muscle with HFrEF, potentially allowing it to more easily accommodate the extra blood flowing into the right atrium, Stone said.

There were no device-related or procedure-related major adverse cardiovascular or neurologic events in either group during the duration of the trial.

Surprisingly, a marked improvement in quality of life as measured with KCCQ was observed across all groups—including those who received a placebo procedure, both with HFrEF and HFpEF—suggesting that the metric may not be a reliable indicator for quality-of-life outcomes in this context, Stone said.

“There was a tremendous placebo effect,” he said. “These observations, especially the fact that quality of life improved in HFpEF patients who were more likely to be hospitalized for heart failure and had reduced survival after shunt treatment, raise questions about the interpretation of this quality-of-life measure in these kinds of trials.”

Although the observed differences in outcomes among people with different types of heart failure may inform future research and development for interatrial devices, the researchers said that the trial was not powered to show differences in the two types of heart failure. As such, these results should be considered exploratory. They also said that the results may not be applicable to other interatrial shunts beyond the Ventura shunt.

The study was funded by V-Wave Medical.

Stone will be available to the media in a press conference on Saturday, April 6, 2024, at 10:45 a.m. ET / 14:45 UTC in Room B203.

Stone will present the study, “A Double-blind, Randomized Placebo Procedure-controlled Trial of an Interatrial Shunt in Patients with HfrEF and HfpEF: Principal Results from the RELIEVE-HF Trial,” on Saturday, April 6, 2024, at 9:30 a.m. ET / 13:30 UTC in the Hall B-1 Main Tent.

Source:

American College of Cardiology

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April 8, 2024
MADs show comparable blood pressure reduction to CPAP in hypertensive patients with sleep apnea

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People with hypertension and obstructive sleep apnea were no less likely to see their blood pressure drop over six months if they used a mandibular advancement device (MAD), which is inserted onto the teeth similar to a bite guard. compared to a continuous positive airway pressure (CPAP) device, according to research featured at the American College of Cardiology’s Annual Scientific Session. Hypertension, or high blood pressure, is a common risk factor for cardiovascular disease. People with obstructive sleep apnea experience frequent sleep interruptions due to the airway closing periodically during sleep. Since obstructive sleep apnea can cause or worsen hypertension, medical guidelines recommend the use of a CPAP machine to help keep airways open by delivering pressurized air through the mouth and nose.

MADs are designed to help keep the airway open by repositioning the lower jaw and moving the tongue forward. Previous studies have shown that CPAP devices outperform MADs in terms of apnea-hypopnea index, the standard metric used to measure sleep apnea severity. However, there is evidence that MADs may be better tolerated than CPAP, which some people find too uncomfortable or cumbersome for sustained use.

In this study, MADs were found non-inferior in terms of change in the average 24-hour ambulatory mean blood pressure at six months and they resulted in a larger reduction across multiple secondary blood pressure parameters compared with CPAP. According to researchers, higher adherence among people assigned to use the MAD device could help explain the findings.

Looking at the totality of evidence available in the literature, it is still reasonable to say that CPAP is the first-line treatment until we have more data on the MAD. However, for patients who truly cannot tolerate or accept using a CPAP, we should be more open minded in looking for an alternative therapy such as a MAD, which based on our study, numerically had a better blood pressure reduction in patients compared with a CPAP.”

Ronald Lee Chi-Hang, MD, professor of medicine at Yong Loo Lin School of Medicine, National University of Singapore, senior consultant in the department of cardiology at National University Heart Centre, Singapore, and one of the study authors

For the study, 321 people with uncontrolled hypertension and high cardiovascular risk underwent a sleep study to determine whether they had obstructive sleep apnea. Of these, 220 people were found to have moderate to severe obstructive sleep apnea and were randomly assigned to receive a MAD or CPAP device. Participants were instructed to use their assigned device for six months while sleeping to the degree that they could tolerate it. Both devices had built-in trackers that recorded use.

At six months, people assigned to the MAD group experienced a drop in 24-hour ambulatory mean blood pressure that was 1.64 mmHg larger, on average, than those assigned to CPAP, meeting the threshold for non-inferiority and the trial’s primary endpoint. Compared with the CPAP group, the MAD group also showed a larger between-group reduction in all ambulatory blood pressure measures, especially nighttime blood pressure when the devices were being used, and an increased proportion of patients achieving a systolic blood pressure below 120 mmHg by the end of the study. None of the participants experienced symptomatic hypotension.

The adherence data revealed that over half (56.5%) of those who were assigned to use the MAD used the device for six or more hours per night on average over the study period, while under one-quarter (23.2%) of those assigned to CPAP did so.

“The MAD patients simply used the device longer,” Chi-Hang said. “That also might explain why the blood pressure reduction at nighttime, when the patients are actually using it, had a better reduction in the MAD arm.”

Adherence to the American Academy of Sleep Medicine’s recommendation of four or more hours of use in at least 70% of nights overall was similar between groups, with 69.4% of those in the MAD group and 64.3% of those in the CPAP group meeting this recommendation. Both groups saw a reduction in daytime sleepiness and the results showed no between-group differences in cardiovascular biomarkers.

Overall, researchers said the results underscore the importance of treating sleep apnea as part of a broader effort to control hypertension and reduce cardiovascular risk.

“People should be aware that over 400 million people globally have moderate-to-severe obstructive sleep apnea, and it is underdiagnosed and may be a contributing factor to their high blood pressure,” Chi-Hang said. “Especially for patients whose blood pressure is hard to control or who have a lot of excessive daytime sleepiness, [it is important to] go see a physician about sleep apnea and get treated if necessary.”

Since the study was conducted in Singapore and most study participants were of East Asian descent, researchers said further studies in more diverse populations are necessary to determine whether the findings are generalizable to other racial and ethnic groups. Chi-Hang also said that the timing of the study, which was conducted during travel lockdowns during the COVID-19 pandemic, may have influenced the results by increasing adherence.

The researchers plan to conduct further studies focused on comparing the impacts of the different types of devices on cognition.

The study was funded by the Singapore Ministry of Health.

This study was simultaneously published online in the Journal of the American College of Cardiology at the time of presentation.

Chi-Hang will present the study, “Mandibular Advancement Device Versus CPAP for Blood Pressure Reduction in Obstructive Sleep Apnea and High Cardiovascular Risk—A Randomized Clinical Non-inferiority Trial,” on Saturday, April 6, 2024, at 4:15 p.m. ET / 20:15 UTC in the Thomas B. Murphy Ballroom 4.

Source:

American College of Cardiology

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April 8, 2024
Investigational drug plozasiran shows promise in reducing severe hypertriglyceridemia

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In patients with severely elevated triglyceride levels at risk for developing acute pancreatitis, the investigational drug plozasiran reduced triglyceride levels by an average of 74% after 24 weeks of use without causing any significant safety concerns, according to research presented at the American College of Cardiology’s Annual Scientific Session.

Plozasiran produced significant reductions in triglyceride levels below the threshold associated with elevated risk for pancreatitis, with a favorable safety profile. These data support the initiation of pivotal studies of plozasiran for the treatment of severe hypertriglyceridemia.”

Daniel Gaudet, MD, PhD, professor of medicine at the University of Montreal and the study’s lead author

Triglycerides are blood lipids (fats) that store unused calories and provide energy to the body. An estimated 1 in 5 U.S. adults—and more than 2 in 5 of adults aged 60 years and older—have elevated triglycerides, defined as over 150 mg/dL. High levels of triglycerides and the lipid particles on which they are carried in the blood can contribute to the formation of “plaques” in the arteries that impede blood flow and can lead to heart attacks and strokes. Severe hypertriglyceridemia—defined as triglyceride levels over 500 mg/dL—can also cause pancreatitis, an inflammatory process in the pancreas that can be life threatening.

ApoC3 is a protein produced in liver cells that inhibits the liver’s ability to clear fats such as triglycerides out of the body. Plozasiran works by reducing the production of ApoC3, thereby enabling the liver to increase its clearance of triglycerides and other fats. The SHASTA-2 trial tested the effectiveness and safety of plozasiran as an add-on to existing lipid-lowering treatment in patients with severe hypertriglyceridemia.

A total of 229 patients (average age 55 years, 78% men and 90% White) were enrolled in the trial in eight countries. Patients’ average triglyceride level at baseline was about 900 mg/dL. Most also had at least three of the following risk factors: elevated risk for or history of cardiovascular disease, diabetes, low HDL (“good”) cholesterol and high body mass index.

Patients were randomly assigned to one of four groups. Three groups received two injections of plozasiran at one of three doses (10 mg, 25 mg or 50 mg); the fourth group received two injections of a placebo. The first injection was given on day one and the second at week 12. The study was double-blinded, meaning that neither the patients nor their clinicians knew who was receiving the drug and who was receiving the placebo until the study was over.

The study’s primary endpoint was the percentage change in fasting triglyceride levels from study entry to 24 weeks. Secondary endpoints included the percentage change in ApoC3 at 24 weeks and every four weeks from baseline through 48 weeks and in fasting triglyceride levels every four weeks through 48 weeks. All patients were followed for 36 weeks after the second dose (for a total of 48 weeks).

At 24 weeks, the average reduction in triglyceride levels in plozasiran-treated patients was 74%, compared with 17% in patients who received the placebo. At 48 weeks the average reduction was 58% in patients who received the highest doses of plozasiran compared with 7% for those in the placebo group. The average reduction in ApoC3 was 78% for plozasiran-treated patients versus 1% for the placebo group at 24 weeks. At 48 weeks, ApoC3 levels were reduced by 48% on average among patients receiving the highest doses of plozasiran, whereas ApoC3 levels increased 4% in the placebo group.

At 24 weeks, over 90% of patients who received the higher doses (25 mg or 50 mg) of plozasiran saw their triglyceride levels fall to below 500 mg/dL, the commonly accepted threshold for an increase in risk for pancreatitis. At 48 weeks, 77% of these patients still had triglyceride levels of less than 500 mg/dL. More than 50% of patients on higher doses achieved triglyceride levels of below 150 mg/dL (i.e., in the normal range) at 24 weeks.

“Significant and durable dose-dependent reductions in ApoC3 and triglycerides persisted through week 48, or 36 weeks after patients received their second dose of plozasiran,” Gaudet said.

Severe hypertriglyceridemia is a challenging condition for which few effective treatments are currently available, he said.

“From the patients’ standpoint, the possibility that in the near future there could be an agent that safely and effectively lowers severely elevated triglyceride levels and reduces or eliminates the risk of developing pancreatitis is extraordinary,” he said.\

Limitations of the study are its relatively small size and short duration and a lack of diversity among the enrolled patients, Gaudet said. The planned phase 3 study will be conducted in a patient population that will include more women and more patients from racial and ethnic minorities.

“What we want to know is how sustained is the effect of plozasiran in a larger, more diverse cohort,” he said.

The study was funded by Arrowhead Pharmaceuticals, the manufacturer of plozasiran.

Gaudet will be available to the media in a press conference on Sunday, April 7, 2024, at 9:30 a.m. ET / 13:30 UTC in Room B203.

Gaudet will present the study, “Plozasiran (ARO-APOC3), An Investigational RNAi Therapeutic, Demonstrates Profound And Durable Reductions In APOC-3 And Triglycerides (TG) In Patients With Severe Hypertriglyceridemia (SHTG), SHASTA-2 Final Results,” on Sunday, April 7, 2024, at 8:00 a.m. ET / 12:00 UTC in the Hall B-1 Main Tent.

Source:

American College of Cardiology

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April 8, 2024
E-cigarette use linked to increased risk of heart failure, large study finds

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People who use e-cigarettes are significantly more likely to develop heart failure compared with those who have never used them, according to one of the largest prospective studies to date investigating possible links between vaping and heart failure. The findings are being presented at the American College of Cardiology’s Annual Scientific Session.

Heart failure is a condition affecting more than 6 million U.S. adults in which the heart becomes too stiff or too weak to pump blood as effectively as it should. It can often lead to debilitating symptoms and frequent hospitalizations as people age. Electronic nicotine products, which include e-cigarettes, vape pens, hookah pens, personal vaporizers and mods, e-cigars, e-pipes and e-hookahs, deliver nicotine in aerosol form without combustion. Since they were first introduced in the U.S. in the late 2000s, electronic nicotine products have often been portrayed as a safer alternative to smoking, but a growing body of research has led to increased concern about potential negative health effects.

More and more studies are linking e-cigarettes to harmful effects and finding that it might not be as safe as previously thought. The difference we saw was substantial. It’s worth considering the consequences to your health, especially with regard to heart health.”

Yakubu Bene-Alhasan, MD, a resident physician at MedStar Health in Baltimore and the study’s lead author

For the study, researchers used data from surveys and electronic health records in All of Us, a large national study of U.S. adults run by the National Institutes of Health, to analyze associations between e-cigarette use and new diagnoses of heart failure in 175,667 study participants (an average age of 52 years and 60.5% female). Of this sample, 3,242 participants developed heart failure within a median follow-up time of 45 months.

The results showed that people who used e-cigarettes at any point were 19% more likely to develop heart failure compared with people who had never used e-cigarettes. In calculating this difference, researchers accounted for a variety of demographic and socioeconomic factors, other heart disease risk factors and participants’ past and current use of other substances, including alcohol and tobacco products. The researchers also found no evidence that participants’ age, sex or smoking status modified the relationship between e-cigarettes and heart failure.

Breaking the data down by type of heart failure, the increased risk associated with e-cigarette use was statistically significant for heart failure with preserved ejection fraction (HFpEF)-;in which the heart muscle becomes stiff and does not properly fill with blood between contractions. However, this association was not significant for heart failure with reduced ejection fraction (HFrEF)-;in which the heart muscle becomes weak and the left ventricle does not squeeze as hard as it should during contractions. Rates of HFpEF have risen in recent decades, which has led to an increased focus on determining risk factors and improving treatment options for this type of heart failure.

The findings align with previous studies conducted in animals, which signaled e-cigarette use can affect the heart in ways that are relevant to the heart changes involved in heart failure. Other studies in humans have also shown links between e-cigarette use and some risk factors associated with developing heart failure. However, previous studies attempting to assess the direct connection between e-cigarette use and heart failure have been inconclusive, which Bene-Alhasan said is due to the inherent limitations of the cross-sectional study designs, smaller sample sizes and the smaller number of heart failure events seen in previous research.

Researchers said the new study findings point to a need for additional investigations of the potential impacts of vaping on heart health, especially considering the prevalence of e-cigarette use among younger people. Surveys indicate that about 5% to 10% of U.S. teens and adults use e-cigarettes. In 2018, the U.S. Surgeon General called youth e-cigarette use an epidemic and warned about the health risks associated with nicotine addiction.

“I think this research is long overdue, especially considering how much e-cigarettes have gained traction,” Bene-Alhasan said. “We don’t want to wait too long to find out eventually that it might be harmful, and by that time a lot of harm might already have been done. With more research, we will get to uncover a lot more about the potential health consequences and improve the information out to the public.”

Bene-Alhasan also said e-cigarettes are not recommended as a tool to quit smoking, since many people may continue vaping long after they quit smoking. The U.S. Centers for Disease Control and Prevention recommends a combination of counseling and medications as the best strategy for quitting smoking.

Researchers said that the study’s prospective observational design allows them to infer, but not conclusively determine, a causal relationship between e-cigarette use and heart failure. However, with its large sample size and detailed data on substance use and health information, Bene-Alhasan said the study is one of the most comprehensive studies to assess this relationship to date.

Source:

American College of Cardiology

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April 2, 2024
Study finds elevated sodium consumption in heart disease patients

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Individuals with heart disease stand to gain the most from a low-sodium diet but, on average, consume over twice the recommended daily sodium intake, according to a study being presented at the American College of Cardiology’s Annual Scientific Session.

Sodium is an essential nutrient, but consuming too much can raise blood pressure, which damages blood vessels and forces the heart to work harder. Excess sodium can also cause the body to retain fluid, exacerbating conditions like heart failure. The current U.S. Dietary Guidelines put out by the U.S. Department of Agriculture recommends most adults limit their sodium intake to less than 2,300 mg/day, which is equivalent to about 1 teaspoon of table salt. For individuals with cardiovascular diseases, the limit is even lower at 1,500 mg/day, according to guideline recommendations from the ACC and the American Heart Association.

This new study found that among a sample of more than 3,100 people with heart disease, 89% consumed more than the recommended daily maximum of 1,500 mg of sodium and, on average, study participants consumed more than twice this amount. Limiting sodium intake is a fundamental lifestyle modification shown to reduce the likelihood of subsequent major adverse cardiovascular events, researchers said. Their findings underscore the challenges many people face in keeping within recommended sodium limits, regardless of other factors such as socioeconomic status.

Estimating sodium quantities in a meal can be challenging. Food labels aid in dietary sodium estimation by providing sodium quantities in packaged food. Yet, adhering to a low sodium diet remains challenging even for individuals with cardiovascular disease who have a strong incentive to adhere.”

Elsie Kodjoe, MD, MPH, internal medicine resident at Piedmont Athens Regional Hospital in Athens, Georgia, and study’s lead author

The study used data from patients diagnosed with a heart attack, stroke, heart failure, coronary artery disease or angina who participated in the National Health and Nutrition Examination Survey (NHANES) between 2009–2018.

Researchers estimated sodium intake based on questionnaires in which participants were asked to report everything they had consumed in 24 hours. According to the results, study participants with cardiovascular disease consumed an average of 3,096 mg of sodium per day, which is slightly lower than the national average of 3,400 mg/day reported by the U.S. Centers for Disease Control and Prevention.

“The relatively small difference in sodium intake suggests that people with cardiovascular disease are not limiting their intake very much compared with the general population and are also consuming more than double what is recommended,” Kodjoe said. “To make it easier for patients to adhere to dietary guidelines, we need to find more practical ways for the general public to estimate dietary sodium levels or perhaps consider a reduction in the sodium content of the food we consume right from the source.”

The researchers also compared sodium intake among people in different socioeconomic groups, but they did not find any significant differences between wealthier and less affluent participants after accounting for age, sex, race and educational attainment.

Individuals can take proactive measures to lower their sodium intake, Kodjoe said. This includes preparing more meals at home where they have greater control over the sodium content and paying close attention to food labels, particularly targeting foods with sodium levels of 140 mg or less per serving. Researchers suggested that better education around the benefits of limiting sodium could also help motivate more people to follow the recommendations.

“Cardiovascular disease is real, and it is the number one cause of morbidity and mortality worldwide according to the World Health Organization,” Kodjoe said. “Adhering to sodium guidelines is one of the easier strategies individuals could readily adopt to reduce hospitalizations, health care costs, morbidity and mortality associated with cardiovascular disease.”

One limitation of the study is that sodium intake was estimated based on food recall questionnaires, rather than 24-hour urine sodium measurements, which is considered the gold standard method. NHANES has included 24-hour urine sodium measurements in its data gathering methods in recent survey cycles, so future studies using this data could provide a more accurate assessment of sodium intake among people with cardiovascular disease.

Source:

American College of Cardiology

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April 2, 2024
Cardiovascular risk can rise sharply after women go through menopause

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Study shows women quickly catch up to men in terms of cardiovascular risk; underscores the need for increased awareness and screening.

A woman’s cardiovascular risk can rise sharply after she goes through menopause, quickly catching up to men of a similar age and health profile, according to new findings presented at the American College of Cardiology’s Annual Scientific Session. Researchers said the study underscores the importance of recognizing and addressing early warning signs of heart disease risk in women as they lose the protective effects of estrogen after menopause.

This is a unique study cohort of only post-menopausal statin users that signals that post-menopausal women may have risk of heart disease that is on par with males. Women are underscreened and undertreated, especially post-menopausal women, who have a barrage of new risk factors that many are not aware of. This study raises awareness of what those risk factors are and opens the door to indicating the importance of increased screening for coronary artery calcium (CAC).”

Ella Ishaaya, MD, internal medicine physician at Harbor-UCLA Medical Center in Torrance, California, and study’s lead author

In the study, post-menopausal women underwent heart scans to assess their CAC score, a measure of plaque buildup—fat, calcium and other substances—in the heart’s arteries. CAC levels are assessed with a quick, non-invasive scan similar to an X-ray. A higher CAC score indicates a higher risk of a heart attack or other cardiac events.

Researchers analyzed data from 579 post-menopausal women who were taking statins to control their cholesterol and had undergone two CAC scans at least one year apart. Participants did not have heart disease at the time of the first scan. To compare CAC changes in men and women, each female participant was matched with a male of a similar profile in terms of age, race, statin use, blood pressure and diabetes status.

Researchers divided the participants into three groups with CAC levels of 1-99, 100-399, and 400 or higher at baseline. Between their first and second heart scan, women with baseline CAC of 1-99 saw their CAC rise by a median of eight points, double the median of four seen in their male counterparts. Similarly, women with baseline CAC of 100-399 saw their CAC rise by a median of 31 points, about double the median of 16 seen in males. There was no significant difference between sexes for those with baseline CAC of 400 or higher.

The findings suggest plaque buildup is accelerated in post-menopausal women compared to men, indicating that many women experience a steep rise in the risk of heart problems. Ishaaya said this is likely related to the drop in estrogen that women experience during menopause. Estrogen has long been known to have a protective effect on heart health, but researchers said many women and even many clinicians are not aware of what it means to lose that protection during menopause.

“After menopause, women have much less estrogen and shift to a more testosterone-heavy profile,” Ishaaya said. “This affects the way your body stores fat, where it stores fat and the way it processes fat; it even affects the way your blood clots. And all of those [changes] increase your risk for developing heart disease.”

Heart disease is the leading cause of death in both men and women, but women’s cardiovascular risk has traditionally been undertreated because women tend to develop heart disease at an older age than men and may experience different and sometimes more subtle symptoms.

Based on these results, researchers suggested post-menopausal women should talk to their doctor about heart disease risk factors and follow up on any recommended tests or monitoring. More women may benefit from heart scans when compared to the number of women currently receiving them, Ishaaya said.

Since all the women in the study were taking statins but many still saw a substantial rise in CAC, the results may also indicate that statins are not sufficient to keep plaque buildup in check for this population, Ishaaya said. Future studies could investigate the effectiveness of statins or other therapies in reducing plaque burden in post-menopausal women, she said.

ACC/American Heart Association guidelines recommend considering a heart scan to assess CAC when a person’s risk level is ambiguous or borderline based on standard risk factors. In the U.S. and many other countries, CAC scoring is most used to determine recommendations for statins for intermediate-risk and asymptomatic patients.

Source:

American College of Cardiology

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April 2, 2024
Social isolation may accelerate biological aging and raise mortality risk
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A new study from Mayo Clinic finds that socially isolated people are more likely to show signs of being biologically older than their age and more likely to die from a variety of causes. The research, published in the Journal of the American College of Cardiology: Advances, suggests that social connection plays an important role in overall physical health and longevity, and it should be addressed as a necessary part of the social determinants of health.

To investigate the role of social contact in biological aging, the researchers compared the Social Network Index and AI-enabled electrocardiogram (AI-ECG)-predicted age gaps of over 280,000 adults who received outpatient care between June 2019 and March 2022. Eligible participants completed a questionnaire on the social determinants of health and had AI-ECG records independent of the study on file within one year.

An AI-ECG model developed at Mayo Clinic was used to estimate biological age, which was then compared to chronological age. Previous research shows that the AI-ECG age prediction represents the heart’s biological age. A positive age gap indicates accelerated biological aging, while a negative value suggests slower biological aging.

Researchers assessed social isolation using the Social Network Index, which asks six distinct multiple-choice questions related to these areas of social interaction:
- Belonging to any social club or organization.
- Frequency of participating in social activities per year.
- Frequency of talking on the telephone with family and friends per week.
- Frequency of attending church or religious services per year.
- Frequency of getting together with friends or family in person per week.
- Marital status or living with a partner.
Each question response was given a score of 0 or 1, and the total score tallies ranged from 0 to 4, representing varying degrees of social isolation.

Participants with a higher Social Network Index score -; indicating a better social network -; had a smaller AI-ECG age gap, and that held true across all gender and age groups. Social network status significantly influenced mortality risk. During the two-year follow-up period, approximately 5% of the participants died. Those who had low social index scores less than or equal to 1 had the highest risk of death compared to other groups.

While the participants were 86.3% non-Hispanic white, the study data point to existing health disparities. Non-white participants had higher average age gaps than their white counterparts, especially those with lower Social Network Index scores.

This study highlights the critical interplay between social isolation, health and aging. Social isolation combined with demographic and medical conditions appears to be a significant risk factor for accelerated aging. But we also know that people can change their behavior -; have more social interaction, exercise regularly, eat a healthy diet, stop smoking, get adequate sleep, etc. Making and sustaining these changes may go a long way toward improving overall health.”

Amir Lerman, M.D., cardiologist at Mayo Clinic and senior author of the paper

Source:

Journal reference:

Rajai, N., et al. (2024). Association Between Social Isolation With Age-Gap Determined by Artificial Intelligence-Enabled Electrocardiography. JACC: Advances. doi.org/10.1016/j.jacadv.2024.100890.
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March 21, 2024
EHRA 2024 explores prevention and treatment of heart rhythm disorders

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7 to 9 April in Berlin, Germany and online

Discover the hottest science in the prevention and treatment of heart rhythm disorders at EHRA 2024, a scientific congress of the European Society of Cardiology (ESC). The annual congress of the European Heart Rhythm Association (EHRA), a branch of the ESC, will be held 7 to 9 April at the CityCube Berlin, Germany, and online. Explore the scientific programme.

Stay tuned for the extensive late-breaking science programme, featuring ground-breaking studies on new devices and techniques in atrial fibrillation, ventricular fibrillation, and sinus node disease. Plus more than 900 abstracts covering novel research across the range of heart rhythm disorders.

More than 120 scientific sessions will showcase the most topical issues in the field. Sustainability is the focus of two sessions exploring whether remote cardiac monitoring can reduce greenhouse gas emissions, when to resterilize and reimplant pacemakers, and whether it is ethical not to reuse catheters and cardiac devices. Professor Serge Boveda, Scientific Programme Committee Chairperson, said: “Arrhythmias management offers numerous opportunities for greener practices, such as manufacturing devices locally to shorten transportation distances, minimizing packaging, and reusing catheters. While decreasing our carbon footprint for everyone’s wellbeing we can save resources and treat more patients at an affordable cost.”

Robotics are an emerging area and experts will discuss their use to treat complex arrhythmias in congenital heart disease, plus randomized trials comparing robotic with conventional ablation.3,4 Professor Jose Luis Merino, EHRA President, said: “Robotics are set to take on a major role in electrophysiology. The early robotic systems were bulky, complex, and expensive, but that is changing with newer generations. Ideally, robotization will improve the reproducibility of procedures and enable us to treat more patients.”

Artificial (AI) update: multiple sessions examining the pros and cons of AI for the prediction of atrial fibrillation, stroke and sudden cardiac death, and for personalized diagnosis and therapy.

New AI-based tools should help us to more accurately predict who will experience arrhythmic events, monitor massive cohorts of patients with heart rhythm disorders remotely and virtually, and better understand the mechanisms of arrhythmias thereby improving treatments. We can also envisage AI making workflows more efficient by automating some tasks and removing the potential for human error.”

Professor Andrea Sarkozy, Scientific Programme Committee Chairperson

Also on the agenda: sudden cardiac death. Leaders in the field will examine how to prevent sudden cardiac arrest in young athletes, the role of genetic testing in pre-participating screening, whether non-professional sportspeople should undergo screening, and how families cope with sudden death. “The way forward is better screening and the widespread use of external defibrillators in stadiums and sports halls,” said Professor Boveda. “Most athletes now survive cardiac arrest due to prompt resuscitation. Systematic study of relatives is essential to assess their arrhythmic risk. In the future, AI may play a role to identify repetitive patterns associated with these events.”

Not to miss: difficult decisions in patients with cancer and arrhythmias. “Contemporary issues include the feasibility of anti-cancer radiotherapy in patients with an implantable cardiac device,” said Professor Merino. “Patients with cancer have a heightened risk of bleeding and there has been concern over the use of anticoagulation to treat arrhythmias but research has shown that the benefits outweigh the risks. We also need greater awareness about the magnetic resonance imaging (MRI)-compatibility of cardiac devices so that cancer patients are not denied important tests.”

The theme of EHRA 2024 is “Innovation and education to overcome arrhythmias”. A new edition of an international consensus statement on surgical and catheter ablation by EHRA and other scientific societies will be presented for the first time and is set to change the face of atrial fibrillation management.

The EHRA Innovation Forum will shine a spotlight on novelties in pacing and arrhythmia monitoring, mapping and imaging, ablation technology, and much more. Professor Sarkozy said: “Electrophysiologists are innovators and the advent of AI is accelerating progress. We are expecting to hear about cutting-edge non-invasive systems to help with screening, pioneering means of cardiac stimulation and defibrillation, and state-of-the-art arrhythmia ablation systems that will be more accurate and effective than traditional methods.”

The EHRA Congress brings together scientists, healthcare professionals and key opinion leaders involved in arrhythmia management from across the globe. Register as press now to attend EHRA2024 and receive press releases from the leading arrhythmias meeting in Europe.

Source:

European Society of Cardiology (ESC)

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March 15, 2024