Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Patrick Campbell

HCPLive interview with Ankeet Bhatt, MD, MBA, ScM, on NUDGE-FLU data from AHA 2024

Ankeet Bhatt, MD, MBA, ScM, on NUDGE-FLU data from AHA 2024

Use of emails highlighting the cardiovascular benefits of influenza vaccination could significantly increase the rate of vaccine uptake among adults with a history of 

, according to a new analysis from the NUDGE-FLU program.

American Heart Association (AHA) Annual Scientific Sessions 2024

, results of the analysis demonstrate messaging highlighting the potential cardiovascular benefits of flu shots led to a 3.9% increase in vaccination among people with a history of heart attack compared to a 2% increase for those with no heart attack history, with results also providing insights into individual-level patient factors influencing rate of vaccine uptake.

“The data suggest that cardiovascular-focused messaging was effective across a broad population; this strategy should be considered as part of a suite of strategies to improve cardiovascular prevention and encourage flu vaccination among high-risk patients, including those with a history of heart attack,” said principal investigator Ankeet Bhatt, MD, MBA, SCM, a cardiologist at Kaiser Permanente San Francisco Medical Center, a research scientist at the Kaiser Permanente Northern California Division of Research, and an adjunct professor at the Stanford University School of Medicine. “Notably, this strategy alone did not close all implementation gaps for flu vaccination. Other strategies in addition to messaging-based intervention need to be tested to fully close this important prevention gap in at-risk patients.”

The NUDGE-FLU program, a groundbreaking initiative launched in Denmark evaluating the effectiveness of behavioral science-informed nudges delivered through government electronic communication systems for improving vaccination rates among high-risk populations. At the time of the AHA 2024 presentation, the program included 3 trials—NUDGE-FLU, NUDGE-FLU-2, and NUDGE-FLU-CHRONIC, which were conducted during the 2022-2023 and 2023-2024 influenza seasons and included a total of 2,146,124 participants.

The original NUDGE-FLU trial randomized 964,870 adults aged 65 and older to receive one of nine behavioral science-informed letters or usual care. NUDGE-FLU-2 involved 881,373 adults in the same age group, randomized to receive one of six behavioral science-informed letters or usual care. NUDGE-FLU-CHRONIC focused on 299,881 adults aged 18 to 64 with chronic conditions, using a similar design. Across all trials, 2.8% (n=59,458) of participants had a history of acute myocardial infarction.

Analysis indicated vaccine uptake improved for both those with and without this history who received any nudge letter compared to usual care (+1.81 vs. +1.32 percentage points, P = .09). Notably, the letter emphasizing the cardiovascular benefits of vaccination yielded greater increases in uptake among those with a history of acute myocardial infarction (+3.91 vs. +2.03 percentage points, 

Additionally, patients who had not been vaccinated in the prior season saw the most significant improvements in vaccine uptake, with a +13.7 percentage point increase for those receiving cardiovascular benefit communications (

 <.001). Investigators also noted this effect was most pronounced in patients with more recent myocardial infarctions (

Relevant disclosures for Bhatt include Sanofi and Novo Nordisk.

Bhatt AS. Electronic Nudges to Increase Influenza Vaccination among Patients with History of Myocardial Infarction: Insights from 3 Randomized Clinical Trials Enrolling >2 Million Patients. Paper presented at: American Heart Association Scientific Sessions 2024; November 15 - 18; Chicago, Il. Accessed November 16, 2024.

American Heart Association. Email reminders improved flu shot rates in Denmark, notably among heart attack survivors. American Heart Association Newsroom. November 11, 2024. Accessed November 17, 2024. https://newsroom.heart.org/news/email-reminders-improved-flu-shot-rates-in-denmark-notably-among-heart-attack-survivors.

Articles

Emails emphasizing the cardiovascular benefits of influenza vaccination significantly increased vaccine uptake among adults with a history of myocardial infarction, as shown by the NUDGE-FLU program. The analysis, presented at the AHA Annual Scientific Sessions 2024, revealed a 3.9% increase in vaccination for those with a heart attack history, compared to 2% for those without. The NUDGE-FLU trials, conducted in Denmark, involved over two million participants and demonstrated that cardiovascular-focused messaging was effective, though additional strategies are needed to fully address vaccination gaps in high-risk patients.

Ankeet Bhatt, MD, MBA, ScM, provides additional insight into NUDGE-FLU data he presented at AHA 2024. 

Understanding NUDGLE-FLU Data from AHA 2024, with Ankeet Bhatt, MD, MBA, ScM

Ankeet Bhatt, MD, MBA, ScM 
Credit: American Heart Association

New data from the landmark NUDGE-FLU program suggests patients with a history of myocardial infarction were more likely to receive a seasonal influenza vaccination after receiving an electronic message highlighting the cardiovascular benefits of flu shots.

Coming more than 2 years after the original NUDGE-FLU trial was presented at ACC.22, the latest study, which included data from more than 2 million patients randomized across 2 flu seasons, found use of the cardiovascular benefits “nudge” was associated with a 1.8% improvement in vaccination rates among heart attack survivors and a 1.3% improvement in rates among adults without a history of heart attack.

“Yearly influenza vaccines help prevent influenza infection and, in patients with a heart attack, are potentially cardioprotective,” said the study’s lead author Ankeet Bhatt, MD, MBA, SCM, a cardiologist at Kaiser Permanente San Francisco Medical Center, a research scientist at the Kaiser Permanente Northern California Division of Research, and an adjunct professor at the Stanford University School of Medicine. “However, there are large gaps in implementing this effective therapy, and novel, scalable strategies to improve flu vaccination rates are needed.”

A revolutionary trial program leveraging behavioral science-informed nudges, delivered via a governmental electronic email/letter system to improve vaccination rates, the NUDGE-FLU program has captivated trialists and the medical community since its initial release. Presented at the 

, the current analysis included all 3 trials from the program—the NUDGE-FLU, NUDGE-FLU-2, and NUDGE-FLU CHRONIC trials, which were conducted during the 2022-2023 and 2023-2024 influenza seasons.

The original NUDGE-FLU trial was conducted during the 2022-2023 influenza season and randomized 964,870 adults aged 65 years and older to 1 of 9 different behavioral science-informed letters or usual care. NUDGE-FLU-2 was conducted during the 2023-2024 influenza season and randomized 881,373 adults aged 65 years and older to 1 of 6 different behavioral science-informed letters or usual care. NUDGE-FLU-CHRONIC was conducted during the 2023-2024 influenza season and randomized 299,881 adults aged 18 to 64 years with a chronic condition to 1 of 6 different behavioral science-informed letters or usual care.

Across the 3 trials, 2,146,124 patients underwent randomization. Of these, 2.8% (n=59,458) had a history of acute myocardial infarction.

Initial analysis revealed improvement in vaccine uptake was comparable in those with vs. without a history of acute myocardial infarction who received any nudge letter compared with usual care (+1.81 vs +1.32 percentage points; 

 = .09). Further analysis found receipt of the letter highlighting cardiovascular benefits of vaccination resulted in greater improvements in vaccine uptake among patients with a history of acute myocardial infarction relative to their counterparts without (+3.91 vs +2.03 percentage points; 

Additionally, investigators pointed out the cardiovascular benefits communications were greater in those who had not received a vaccination in the prior season (+13.7 vs +1.48 percentage points; 

<.001). Investigators also called attention to differences among participants based on time since event, with a more pronounced effective observed in patients with more recent acute myocardial infarction (

“The data suggest that cardiovascular focused messaging was effective across a broad population; this strategy should be considered as part of a suite of strategies to improve cardiovascular prevention and encourage flu vaccination among high-risk patients, including those with a history of heart attack,” Bhatt said. “Notably, this strategy alone did not close all implementation gaps for flu vaccination. Other strategies in addition to messaging-based intervention need to be tested to fully close this important prevention gap in at-risk patients.”

The NUDGE-FLU program demonstrated that electronic messages emphasizing the cardiovascular benefits of influenza vaccination increased vaccination rates among myocardial infarction patients. Conducted over two flu seasons, the study involved over 2 million patients and showed a 1.8% improvement in vaccination rates for heart attack survivors. The program's trials, including NUDGE-FLU, NUDGE-FLU-2, and NUDGE-FLU CHRONIC, highlighted the effectiveness of behavioral science-informed nudges. Despite the success, the study suggests that additional strategies are necessary to address the remaining gaps in flu vaccination implementation among high-risk patients.

Electronic messages highlighting cardiovascular benefits of flu shots increased vaccination rates by 1.8% in heart attack survivors.

NUDGE-FLU Analysis Finds History of Heart Attack Increases Effectiveness of CV Gain Frame Letter

Results of the OPTION trial, which examined use of the WATCHMAN FLX device for left atrial appendage closure (LAAC) as part of a standard post-ablation strategy in 

, indicate the study met both its primary safety and efficacy endpoint, with the WATCHMAN FLX device demonstrating superiority to OAC for bleeding events and noninferiority for a composite of all-cause mortality, stroke, and systemic embolism at 36 months.

"The OPTION trial data provide clinical evidence indicating that, among patients who have undergone an ablation, LAAC with the WATCHMAN FLX device is not only as safe, but superior to OAC therapy for reducing the risk of long-term bleeding events," said principal investigator Oussama Wazni, MD, vice chairman of Cardiovascular Medicine and section head, Cardiac Electrophysiology, Cleveland Clinic.

"Notably, we found high rates of procedural success in patients who had a WATCHMAN FLX implant after an ablation, and of patient adherence to their prescribed medication regimen following the procedures, which likely reinforced positive outcomes such as the low rates of ischemic and hemorrhagic stroke within the trial population."

, included 1600 patients. For inclusion patients needed to have atrial fibrillation, an elevated CHA2DS2-VASc scale, and have undergone catheter ablation. These patients were randomized in a 1:1 ratio to undergo LAAC or receive oral anticoagulation, with 803 patients randomized to LAAC and 797 randomized to anticoagulant therapy. The study cohort had a mean age of 69.6 (SD, 7.7) years, 34.1% were female, the mean CHA2DS2-VASc scale score was 3.5 (SD, 1.3).

The primary safety endpoint of the trial, which was tested for superiority was non-procedure-related major bleeding or clinically relevant nonmajor bleeding. The trial’s primary efficacy endpoint, which was tested for noninferiority, was a composite of all-cause mortality, stroke, or systemic embolism at 36 months.

Upon analysis, results indicated a primary safety endpoint event had occurred among 8.5% of the LAAC group and 18.1% of the anticoagulation group (

<.001 for superiority) at 36 months. Analysis of the primary efficacy endpoint suggested events occurred among 5.3% of the LAAC group and 5.8% of the anticoagulation group (

Since the trial was debuted at AHA 2024, it has been the subject of wide-reaching praise and criticisms, with some calling attention to the trial’s limitations, including a small sample size, use of a noninferiority endpoint, and leveraging an intention-to-treat analysis. For more on the results and his perspective on the trial's critiques, the 

 caught up with Wazni on-site at AHA 2024.

Oussama Wazni, MD: OPTION Trial and the Role of LAAC in Atrial Fibrillation

Relevant disclosures for Wazni include Boston Scientific.

Wazni OM. Randomized Comparison of Left Atrial Appendage Closure with Oral Anticoagulation after Catheter Ablation for Atrial Fibrillation. Paper presented at: American Heart Association Scientific Sessions 2024; November 15 - 18; Chicago, Il. Accessed November 16, 2024.

Boston Scientific Corporation. Boston Scientific Watchman FLXTM left atrial appendage closure device demonstrates superior bleeding risk reduction to oral anticoagulation following a cardiac ablation in the option clinical trial. Boston Scientific. November 16, 2024. Accessed November 17, 2024. https://news.bostonscientific.com/2024-11-16-Boston-Scientific-WATCHMAN-FLX-TM-Left-Atrial-Appendage-Closure-Device-Demonstrates-Superior-Bleeding-Risk-Reduction-to-Oral-Anticoagulation-Following-a-Cardiac-Ablation-in-the-OPTION-Clinical-Trial.

The OPTION trial evaluated the WATCHMAN FLX device for left atrial appendage closure (LAAC) in post-ablation atrial fibrillation patients, demonstrating its superiority over oral anticoagulation (OAC) in reducing bleeding events and noninferiority in preventing all-cause mortality, stroke, and systemic embolism over 36 months. Conducted with 1600 patients, the trial showed high procedural success and medication adherence. Despite its success, the trial faced criticism for its small sample size and use of a noninferiority endpoint. The trial was presented at the AHA Annual Scientific Sessions 2024.

Oussama Wazni, MD, discusses the results of the OPTION trial examining LAAC in atrial fibrillation as well as its reception as AHA 2024. 

Oussama Wazni, MD, MBA: OPTION Trial and the Role of LAAC in Atrial Fibrillation

Aleenah Mohsin, MD, MBBS
Credit: American Heart Association

An analysis of data from the US Centers for Disease Control and Prevention (CDC) WONDER Database is shedding light on just how impactful the rising 

 epidemic has been on rate of mortality within the US.

 related to obesity increased by roughly 180% from 1999 to 2020, with the greatest increases seen among middle-aged men aged 55 to 64 years, Black adults and people who live in the Midwestern states and non-metropolitan areas in the US.

“Obesity is a serious risk factor for ischemic heart disease, and this risk is going up at an alarming rate along with the increasing prevalence of obesity,” said lead investigator Aleenah Mohsin, MD, MBBS, a post-doctoral research fellow at Brown University in Providence, Rhode Island.

 “It is important for everyone, particularly people in high-risk groups, to take steps to manage their weight and reduce their risk of heart disease. Lifestyle changes are key, such as eating healthier, exercising regularly and working with health care professionals to monitor heart health.”

Since the turn of the century, US public health and health systems across the globe have been made to grapple with a growing obesity epidemic. Although the rising rates of obesity, particularly, within the US have been well-documented, much less research has been performed to better understand the impact on obesity-related mortality.

With this in mind, Mohsin and an international team of investigators launched the current study to evaluate trends in obesity-related ischemic heart disease, with additional interest in assessing racial, local, regional, age and gender-wise differences in this trend. To do so, investigators designed their study as an analysis of data from 1999 to 2020 within the CDC’s Wide-Ranging Online Data for Epidemiologic Research (WONDER) database.

The primary outcome of interest for the investigators’ analysis was crude and age-adjusted mortality rates (AAMR) per 100,000 individuals. investigators noted plans to calculate average annual percentage change (AAPC) for AAMRs using joinpoint regression analysis.

During the study period, investigators identified a total of 226,267 deaths occurred due to obesity-related ischemic heart disease. Analysis of trends revealed a uniform rise in AAMR from 1999 to 2020, with an AAPC of 5.03 (95% CI, 4.5 to 5.4).

Subgroup analyses suggested males (3.9) had a greater AAMR than females (2.2) and also experienced a more prominent incline in mortality rates (AAPC, 5.11; 95% CI, 4.1 to 6.1), during the study, particularly among males aged 55 to 64 years (AAMR, 8.5). Investigators also pointed out the greatest rise in AAMR was observed among Black adults (AAMR, 3.93).

Additionally, investigators called attention to significant variation by geographical location, with the greatest AAMR observed among those in Midwest states (AAMR, 3.3) followed by Western states, Southern States, and Northeastern states. When examining specific states instead of regions, the greatest AAMR was observed for Vermont (AAMR, 10.4) and Alabama (AAMR, 1.5) had the lowest.

“The relative change in ischemic heart disease deaths related to obesity that was observed in this study between 1999 and 2020 was greater than the overall increase in obesity prevalence that we’ve seen in the United States, from about 30% to about 40% over this same time frame,” said Sadiya Khan, who was not involved in the study, but serves as an associate professor of cardiology, medical social sciences and preventive medicine (epidemiology) at Northwestern School of Medicine as well as chair of the writing group for the AHA’s PREVENT equations.

 “There are a few potential reasons that could be the case. It may just be that people are more aware of obesity as a risk factor or are more likely to treat obesity, and, therefore, it is more likely to be included on death certificates, which were the basis of these data. The important thing is that we know we need to do more to identify, manage and treat obesity-related risk.”

Shaukat MT, Mohsin A, CHaudhary AJ, et al. Trends in Obesity-related Ischemic Heart Disease Mortality in the United States from 1999 to 2020. Paper presented at: American Heart Association Scientific Sessions 2024; November 15 - 18; Chicago, Il. Accessed: November 16, 2024.

American Heart Association. Obesity-related heart disease deaths increased in the U.S. over the past two decades. American Heart Association Newsroom. November 11, 2024. Accessed November 17, 2024. https://newsroom.heart.org/news/obesity-related-heart-disease-deaths-increased-in-the-u-s-over-the-past-two-decades.

The analysis of CDC WONDER Database data highlights the significant impact of the obesity epidemic on mortality rates in the US, particularly concerning ischemic heart disease. From 1999 to 2020, obesity-related ischemic heart disease mortality increased by approximately 180%, with notable rises among middle-aged men, Black adults, and residents of the Midwest and non-metropolitan areas. The study underscores the importance of lifestyle changes and weight management, especially for high-risk groups, to mitigate heart disease risk. The findings emphasize the need for enhanced identification, management, and treatment of obesity-related risks.

Obesity-related ischemic heart disease deaths rose from 1999 to 2020, particularly in middle-aged men and Black adults, per CDC WONDER data.