Circulation, Volume 150, Issue Suppl_1, Page A4141927-A4141927, November 12, 2024. Background:Prior data suggest the MI risk may be higher with paroxysmal AF (PAF) vs. non-paroxysmal AF (non-PAF). Proposed mechanisms include tachycardia-induced oxidative stress (via LOX-1) with microvascular flow abnormalities, ischemia downstream of a fixed coronary obstruction, and plaque rupture.Methods:We compared MI rates in pts with PAF vs. non-PAF in COMBINE AF, a patient-level metanalysis of 4 RCTS of DOACs vs warfarin (ARISTOTLE, ENGAGE AF-TIMI 48, RE-LY,ROCKET AF). Secondary endpoints were ischemic stroke and CV death. Cox proportional-hazards models stratified by trial and adjusted for elements of the CHADS-VASc score were constructed. Sensitivity analyses were performed across subgroups, omitting pts on lower-dose DOAC regimens, and accounting for competing risk of death.Results:Of 71,466 pts, 16,609 (23%) had PAF at enrollment. Pts with PAF vs non-PAF were similar age (median 72 vs 72. P=0.15), but more likely women (43 vs 36%), with prior CAD (35 vs 31%), and on aspirin (41 vs 32%); but less likely Asian race (12 vs 15%) or with CHADS-VASc score >4 (59 vs 60%), p160,000 pt-yrs of follow-up, 1033 MIs occurred: 277 (1.67%) in pts with PAF vs 766 (1.40%) in pts with non-PAF, corresponding to rates of 0.81% and 0.70% per pt-year. The HRadjfor MI with PAF vs non–paroxysmal AF was 1.17 [1.02-1.35], p=0.028 (Fig). Ischemic stroke occurred in 364 (2.19%) vs 1425 (2.60%) pts with PAF vs non–paroxysmal AF (HRadj0.81 [0.72-0.91], p
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Abstract 4141963: Patient Perspectives of Genetic Testing in Adult Congenital Heart Disease
Circulation, Volume 150, Issue Suppl_1, Page A4141963-A4141963, November 12, 2024. Background:Long-term survival of patients with congenital heart disease (CHD) has increased significantly in the past 40 years, resulting in the largest adult congenital heart disease (ACHD) population in history. Pathologic genetic variation significantly contributes to development, heritability, and outcomes of CHD. International guidelines for genetic testing in syndromic, familial, and complex CHD requiring intervention were published in the last decade and did not address the ACHD population, who was diagnosed well before this era. Perceptions of ACHD patients regarding genetic testing are unknown.Aims:Assess the proportion of ACHD patients that have received genetic testing compared to those that would be considered for testing based on current recommendations. Assess interest and perceived risks and benefits of genetic testing and how these are impacted by clinical and family factors.Methods:Single center prospective cohort survey of consecutive ACHD patients 18 years or older seen in outpatient clinics over a 5-month period.Results:Data were provided by 124 survey respondents, 48.4% female with median age 29.1 years (IQR 23.1-37.8). A majority of respondents (68.3%) have children or plan to have children. Few respondents (10.5%) report prior genetic testing. The majority desire genetic testing (65.3%), while only 8.1% would not choose to have testing performed. Respondents mostly believe testing should occur either during infancy (36.1%) or in adulthood before having children (29.5%). Personal and family health considerations were among the most important motivating factors for consideration of genetic testing, while financial factors were not as prioritized, as shown in Figure 1. Few respondents felt genetic testing would have a negative impact on their mental health (4.2%); the majority felt there would be a positive (53.3%) or neutral (42.5%) effect.Conclusions:Many ACHD patients would have received genetic testing if born in the current era, but very few have been offered such testing given a lack of recommendations in the ACHD population. Broadening genetic evaluation for the adult CHD population should be considered given patient interest and current pediatric CHD recommendations.
Abstract 4123478: The Impact of Social Determinants on Growth at 10 Years After the Norwood Procedure: Results from the Single Ventricle Reconstruction (SVR) Trial III
Circulation, Volume 150, Issue Suppl_1, Page A4123478-A4123478, November 12, 2024. Background:The impact of social determinants of health (SDOH) on growth in patients with hypoplastic left heart syndrome (HLHS) is understudied. In a secondary analysis of the Pediatric Heart Network SVR III study, we explored the impact of SDOH on longitudinal somatic growth through age 10 years in transplant-free survivors with HLHS.Methods:Z-scores adjusted for age for weight (WAZ), height (HAZ), and BMI (BMIZ) were categorized at age 10 years. To assess relationships between z-scores at 10 years and SDOH variables, we modeled all annual measurements for each z-score outcome using a multivariable mixed effects regression that included an interaction between the SDOH predictor and age. We included Hollingshead Score (HH) as a SDOH marker. A higher HH indicates better family socioeconomic status.Results:Of 555 subjects enrolled in the SVR trial, 191 had 10-year growth data. The mean WAZ and HAZ were below normal, with values of -0.3±1.3 (p
Abstract 4147920: Optimal Approach to Generate Patient-Level Decision from Study-Level Predictions Using a Multimodal Deep Learning Model for Detecting Transthyretin Cardiac Amyloidosis
Circulation, Volume 150, Issue Suppl_1, Page A4147920-A4147920, November 12, 2024. Background:Transthyretin cardiac amyloidosis (ATTR-CA) is an underdiagnosed cause of heart failure and early disease detection is essential for improving outcomes. We previously developed a multimodal deep learning model, named ATTRact-Net, leveraging electrocardiogram (ECG) and echocardiogram data that can identify patients with ATTR-CA. Patients at risk for ATTR-CA often have multiple ECGs and echos available for analysis, leading to many different risk predictions by AI models. There is little evidence on how to go from study-level prediction to patient-level decision. We studied varying methods to integrate multiple ECG/echo pair predictions to maximize model performance in the detection of ATTR-CA. We hypothesized that retaining the patient-level mean risk across the prior 2 years would improve model performance compared to using maximum predicted risk.Methods and Results:ATTRact-Net was originally trained on 799 patients with 22,344 ECG/echo pairs completed within 2 years of PYP scan. Previously published performance of the model showed an AUROC of 0.83 in internal testing. For this study, a new test set composed of an outside hospital not used for training, had 422 patients with 12,387 pairs and ATTR-CA prevalence of 23%.In this new hospital’s population, we tested model performance using four patient-level aggregation methods (mean, median, max, and no aggregation) for integrating predictions across multiple ECG/echo pairs. Performance was compared based on the area under the receiver operating characteristic curve (AUROC), Diagnostic Odds Ratio (DOR), and F1 score using the Youden index as the optimal threshold.In the external validation dataset, the model achieved AUROCs of 0.78 (max), 0.82 (mean), 0.82 (median) and 0.82 (none) shown in Figure 1A. Mean and median aggregation outperformed both max and no aggregation by F1-score and DOR (Figure 1B).Conclusion:For a multimodal AI model detecting ATTR-CA, aggregating ECG/echo risk predictions using mean or median from the prior 2 years considerably improved diagnostic yield compared to using patient’s maximum score or no aggregation. A prospective clinical trial is underway using this strategy for early diagnosis of ATTR-CA across our healthcare system.
Abstract 4146939: Impact of Diagnosis Timing (Early vs Late) on Atrial Fibrillation Progression in Patient with New Onset Atrial Fibrillation During COVID Illness
Circulation, Volume 150, Issue Suppl_1, Page A4146939-A4146939, November 12, 2024. Background:New onset AF during acute illness has a high rate of AF recurrence within 5-yr. However, little is known about AF progression in patients with new onset AF during COVID illness. It is also unknown whether the time of COVID diagnosis (early vs late) impacts AF progression. More specifically, did the potentially different immune and inflammatory responses during early vs late COVID produce structural and electrical cardiac remodeling that would increase the likelihood of AF progression.Objective:We sought to compare AF progression in patients with new onset AF during early vs late COVID and hypothesized that early COVID was associated with increased AF progression compared to late COVID.Methods:From Apr 2020 to Feb 2024, patients receiving a SARS-2-CoV test without a history of AF with new onset AF and at least 3-mo of follow up were included (N=11,767). Patients were subdivided based on pos vs neg SARS-2-CoV test and time of diagnosis. Early COVID diagnosis (n=3052) included Apr 2020-Aug 2021 and late COVID (n=8715) included Sep 2021-Feb 2024. AF progression endpoints at 3-, 6- and 12-mo included AF hospitalization, AF emergency department (ED) visit, cardioversion and AF ablation.Results:Patients with late COVID were more likely females with hypertension, coronary artery disease and hyperlipidemia compared to early COVID patients. At 3- and 6-mo follow-up there was no difference in AF progression between the early and late COVID groups for any endpoint. In contrast, at 12-mo follow up there was in increase in late diagnosis group AF ED visits (11% vs 7.6%,p
Abstract 4141125: Lower Limit of Normal for Left Atrial Strain: An updated Systematic Review with Bayesian Meta-Analysis from 10,533 Healthy Subjects
Circulation, Volume 150, Issue Suppl_1, Page A4141125-A4141125, November 12, 2024. Background:Left atrial (LA) strain is an established marker of LA function. Our previous meta-analysis (Pathan, 2017) from 2,542 healthy subjects reported 39.4% with lower limit of normal (LLN) at 38.0%. However, subsequent original studies revealed much lower LLN, ranging from 15.1% to 28.2% (Figure). The LLN is critically important for clinical practice to distinguish abnormal LA function from normal. Thus, we hypothesised that a Bayesian meta-analysis to pool LLN from healthy individuals would determine a clinically meaningful cut-off threshold for LA strain.Aim:As there has been a large number of recent studies reporting normal LA strain since 2017, we aimed to update our systematic review and run Bayesian analysis for LLN of LA strain.Methods:Following PRISMA Guidelines, an updated systematic review was conducted by searching PubMed, Embase, and Scopus databases. Studies of LA strain were included if they involved >20 healthy patients without cardiac disease or risk factors between 2016 and September 2022. Mean LA reservoir strain with 95% confidence intervals were extracted from eligible studies. We use Bayesian meta-analysis to pool the lower 95% confidence interval of the LA reservoir strain from included studies. Prior to pooling the result, we standardised the data with log transformation. The priori used in this model was based on weak informative prior with N (0,1) as the prior distribution. The posterior mean was then exponentiated to obtain the lower reference value and its 95% credible interval (CI).Results:Sixty-three studies (10,533 healthy patients) satisfied inclusion criteria. Our updated Bayesian Meta-analysis demonstrated a pooled mean of 37.8% [95% CI: 36.1, 39.4] with LLN at 22.4% [20.6, 24.3], which is more concordant with recent original studies (Figure).Conclusions:The normal mean LA strain has been updated by pooling >10,000 subjects. The updated LLN of 22.5% may represent a better clinical cut-off for normal LA strain to identify individuals with abnormal LA strain.
Abstract 4120312: Patient Perspectives on Barriers and Facilitators to Familial Hypercholesterolemia Cascade Testing Through the Lens of the Socio-Ecological Model
Circulation, Volume 150, Issue Suppl_1, Page A4120312-A4120312, November 12, 2024. Background:Low uptake of Familial Hypercholesterolemia (FH) cascade testing, the stepwise identification of at-risk relatives, leads to missed opportunities for atherosclerotic cardiovascular disease (ASCVD) prevention. The IMPACT-FH study offered strategies (packet, chatbot, and direct contact) to support FH cascade testing.Hypothesis:We hypothesized that IMPACT-FH strategies would facilitate cascade testing uptake and overcome persistent barriers to cascade testing.Aim:We aimed to understand barriers and facilitators to FH cascade testing in the context of the socio-ecological model (SEM) which provides a framework to examine the interconnected influences of intrapersonal, interpersonal, institutional, community, and policy levels.Methods:Semi-structured interviews were conducted with IMPACT-FH study participants. The SEM informed qualitative analysis to identify barriers and facilitators to FH cascade testing.Results:A total of 15 FH probands (initial family member tested) and 12 relatives were interviewed, of whom the majority (59%) were female with an average age of 55.7 years. All relatives completed cascade testing. At the interpersonal level, probands reported that relatives’ attitudes about high cholesterol, including seriousness and treatability, were a barrier or facilitator to cascade testing. Probands explained how relatives’ beliefs were informed by interactions with their clinicians and societal beliefs about cholesterol (i.e., medication stigma). Interpersonally, probands described challenges overcoming relatives’ beliefs and a reluctance to encourage relatives to complete testing despite the availability of novel strategies. Probands and relatives reported that insurance policies and concerns about testing costs informed cascade testing decision-making. Institutional strategies to provide low-cost testing and cost transparency were described as facilitators. Variable access to clinicians with genetics expertise and licensure laws were described as barriers by out-of-state relatives. Probands and relatives agreed that strategies providing direct access genetics expertise (i.e., direct contact, chatbot) helped address these barriers.Conclusion:The IMPACT-FH study ameliorated barriers at higher levels of the SEM related to access to genetics expertise and cost. Intra- and interpersonal barriers remained challenging to overcome. To improve FH detection and ASCVD prevention, it is important to address barriers at all levels of the SEM.
Abstract 4138374: Coronary Endothelial Dysfunction Plays Important Roles on Development of Acute Coronary Syndrome and Fatal Cardiovascular Events During Long-Term Follow-up Over 10 Years
Circulation, Volume 150, Issue Suppl_1, Page A4138374-A4138374, November 12, 2024. Introduction:Although coronary endothelial dysfunction is thought to affect coronary atherothrombogenic processes, there has been little practical evidence for the relationship between clinical evolution of fatal or non-fatal acute coronary syndrome and coronary endothelial dysfunction.Hypothesis:We assessed hypothesis that coronary endothelial dysfunction has clinical impacts on development of acute coronary syndrome and fatal cardiovascular events.Methods:Coronary endothelial dysfunction was practically graded by the flow-mediated endothelium-dependent reactive changes in coronary artery diameter (CFMD) to infusion of adenosine triphosphate (ATP ; 50μg) into the normal left coronary artery using quantitative coronary arteriography in 150 patients with stable coronary artery disease. The enrolled patients were categorized into tertile groups according to the values of CFMD, and we prospectively followed-up major adverse clinical cardiac events including acute coronary syndrome and cardiovascular death.Results:For a mean follow-up period of 132 months (range; 120 to 144) with complete follow-up, the patients in the lower third with severe coronary endothelial dysfunction (Group-L) more frequently developed acute coronary syndrome than those in the middle third with mild coronary endothelial dysfunction (Group-M) plus those in the higher third without coronary endothelial dysfunction (Group-H) [Group-L versus Group-M plus Group-H: 15(30%) versus 5(10%) plus 0(0%), p
Abstract 4140803: Vasomotion in human arteries and its ion channelbased on regulations: 10 years study
Circulation, Volume 150, Issue Suppl_1, Page A4140803-A4140803, November 12, 2024. Vasomotion is the oscillation of vascular tone which gives rise to flow motion of blood into an organ. As is well known, spontaneous contractile organs such as heart, GI, and genitourinary tract produce rhythmic contraction. It imposes or removes pressure on their vessels alternatively for exchange of many substances. It was first described over 150 years ago, however the physiological mechanism and pathophysiological implications are not well understood. This study aimed to elucidate underlying mechanisms and physiological function of vasomotion in human arteries. Conventional contractile force measurement, immunohistochemistry, and Western blotting were employed to study human left gastric artery (HLGA) and uterine arteries (HUA). RESULTS: Circular muscle of HLGA and/or HUA produced sustained tonic contraction by high K+(50mM) which was blocked by 2µM nifedipine. Stepwise stretch and high K produced nerve-independent spontaneous contraction (vasomotion) (around 45 % of tested tissues). Vasomotion was also produced by application of Bayk 8644, 5-HT, prostagrandins, oxytocin. It was blocked by nifedipine (2µM) and blockers of intracellular Ca2+stores. Inhibitors of Ca2+-activated Cl-channels (DIDS and/or niflumic acid) and ATP-sensitive K+(KATP) channels inhibited vasomotion reversibly. Metabolic inhibition by sodium cyanide (NaCN) and several neuropeptides also regulated vasomotion in KATPchannel-sensitive and -insensitive manner. In Next step, we identified TMEM16A Ca2+-activated Cl-channels and subunits of KATPchannels (Kir 6.1/6.2 and sulfonylurea receptor 2B (SUR2B)), and c-Kitpositivity by Western blot. Fianally, we also foud regulation of vasomotion by other second messengers in HLGA and muscle specific events too. We conclude that vasomotion is sensitive to TMEM16A Ca2+-activated Cl-channels and metabolic changes in human gastric and uterine arteries. Vasomotion might play an important role in the regulation of microcirculation dynamics even in pacemaker-related autonomic contractile organs in humans.
Abstract 4142521: A Heart Transplant Patient’s Mysterious Illness: A Diagnostic Odyssey
Circulation, Volume 150, Issue Suppl_1, Page A4142521-A4142521, November 12, 2024. A 60-year-old male patient underwent orthotopic heart transplant for non-ischemic cardiomyopathy three years ago. Recently, he has been followed closely in transplant clinic for persistently elevated donor-derived cell-free DNA; endomyocardial biopsy was negative for allograft rejection. Cardiac MRI showed a global increase in T1 signal with normal T2 suggestive of nonspecific myocardial injury. He later presented with fever and diarrhea. Physical examination revealed pale conjunctivae, non-edematous extremities, and no jugular venous distension. Leukocyte count was 10.1 x103/uL, hemoglobin 14 g/dL, platelets 407 x103/uL, creatinine 1.2 mg/dL, AST 53 U/L, ALT 50 U/L, total bilirubin 0.7 mg/dL. Infectious disease workup was positive for norovirus, which was managed conservatively. He returned a week later with sudden right-sided weakness, confusion, and recurrent fever. Brain MRI was negative for acute pathology. Leukocyte count was elevated in the cerebral spinal fluid. No other etiology could be identified. Eventually, microbial cell-free DNA test was positive for toxoplasma gondii. Follow-up endomyocardial biopsy with hematoxylin and eosin stain confirmed diagnosis of toxoplasmosis. He was started on sulfadiazine, pyrimethamine, and folinic acid for six weeks. Follow up biopsy one month later was negative for toxoplasma gondii. Toxoplasmosis can be reactivated in immunocompromised individuals. Cardiac involvement is rare but can lead to myocarditis, pericarditis, or arrhythmias. Post-transplant toxoplasmosis is often due to transmission from the allograft rather than reactivation. Endomyocardial biopsy with special staining can help differentiate between infection and allograft rejection. Microbial cell-free DNA testing can also help isolate rare infectious etiologies, especially when other serum markers are inconclusive. This case illustrates: (1) the importance of differential diagnosis in post-transplant patients and the benefit of microbial cell-free DNA testing, (2) the need to consider various diagnoses in cases of elevated donor-derived cell-free DNA, (3) the necessity for increased awareness of Toxoplasma gondii infection in transplant patients with compatible symptoms, and (4) the crucial role of a multidisciplinary approach in delivering high-quality care in complex cases.
Abstract 4146626: CYP2C19 Genotyping Decreases 5 and 10-year Mortality in Patients With History of In-Stent Restenosis Undergoing Percutaneous Coronary Intervention
Circulation, Volume 150, Issue Suppl_1, Page A4146626-A4146626, November 12, 2024. Introduction:CYP2C19 genotyping is a genetic test that checks for variations in the gene that codes for an enzyme that metabolizes clopidogrel. Testing has been shown to accurately predict response to clopidogrel; however, the impact of testing on mortality is not currently known.Hypothesis:Our objective was to compare the mortality among patients with a history of in-stent restenosis after percutaneous coronary intervention and initiation of dual antiplatelet therapy who have undergone CYP2C19 genotyping to those who have not undergone CYP2C19 genotyping. We hypothesize that patients who underwent CYP2C19 genotyping will have decreased 5 and 10-year mortality.Methods:A large retrospective database, Trinetix, was used to identify patients aged greater than 18 years old with a history of in-stent restenosis after percutaneous coronary intervention and initiation on dual antiplatelet therapy with either CYP2C19 genotyping or without CYP2C19 genotyping. Two cohorts were subsequently followed depending on if genotyping was performed. Student’s t-test was performed to compare baseline characteristics between cohorts. Demographics and comorbidities were used for 1:1 propensity matching. Kaplan-Myer curves and hazard-ratios were calculated to compare 5 and 10-year mortality.Results:Patients that underwent CYP2C19 genotyping (n=144) and did not undergo CYP2C19 genotyping (n=35,039) were propensity matched yielding 142 patients per cohort. In patients with a history of in-stent restenosis, CYP2C19 genotyping was associated with a decreased 5-year mortality (18.98% vs 29.93%; HR=0.542; 95% CI [0.331, 0.887], log-rank p= 0.0134) and 10-year mortality (23.36% vs. 34.31%; HR=0.542; 95% CI [0.345, 0.852], log-rank p=0.0071) compared to no CYP2C19 genotyping.Conclusion:In patients with a history of in-stent restenosis, undergoing CYP2C19 genotyping was associated with a decreased risk for mortality when compared to not undergoing CYP2C19 genotyping. Prospective randomized trials are needed to further guide patient selection for CYP2C19 genotyping.
Abstract 4141955: A Case of Dilated Cardiomyopathy and Systemic Thromboembolism in a Young Patient on Testosterone Replacement Therapy
Circulation, Volume 150, Issue Suppl_1, Page A4141955-A4141955, November 12, 2024. Introduction:Whereas low testosterone levels have been associated with poor cardiovascular outcomes and testosterone replacement therapy (TRT) in middle-to-older age adults with cardiovascular risk factors is considered safe, there is little data on the adverse cardiovascular effects of TRT in young adults.Case Report:A 38-year-old male with a past medical history of hypogonadism, recently started on intramuscular testosterone cypionate injections, presented to the hospital with altered mentation. Laboratory workup was remarkable for hemoglobin of 19 g/dL. Computed tomography (CT) angiogram of the head demonstrated a left middle cerebral artery infarct with a filling defect, requiring mechanical thrombectomy. A transthoracic echocardiogram (TTE) was done which revealed a dilated left ventricle (LV) with severely reduced LV systolic function, EF 20%, and global hypokinesis. There was no LV thrombus or evidence of a patent foramen ovale with contrast saline injection. He did not have any episodes of atrial fibrillation on telemetry monitoring. His hospital course was further complicated by an inferolateral ST elevation myocardial infarction (STEMI) due to distal left anterior descending (LAD) artery occlusion. He underwent drug-eluting stent placement and was started on dual antiplatelet therapy. Repeat TTE demonstrated new apical akinesis along with an LV apical thrombus of 1.1 x 0.8 cm. CT abdomen/pelvis with contrast demonstrated left renal and right iliofemoral thrombosis and the patient was also started on systemic anticoagulation.Discussion:Data suggests that physiologic levels of testosterone exhibit cardioprotective effects and low testosterone levels are associated with increased cardiovascular mortality. However, studies have also shown that testosterone use is associated with an increased risk of thrombosis and coronary artery disease. Additionally, testosterone use has been associated with myocardial apoptosis and adverse cardiac remodeling from dysregulation of androgenic receptors, which results in dilated cardiomyopathy. There is an ongoing debate on the safety of TRT, however, studies on TRT have largely included the middle and older male population and there is little data on younger patients. Herein, we demonstrate a case of TRT in a patient with several cardiovascular risk factors, who developed evidence of possible TRT-associated cardiomyopathy in addition to hypercoagulability.
Abstract 4146110: Patient Characteristics In The Enhancing Cardiac Rehabilitation Adherence Through Home-Based Rehabilitation And Behavioral Nudges (ERA-Nudge) Study
Circulation, Volume 150, Issue Suppl_1, Page A4146110-A4146110, November 12, 2024. Introduction:Outpatient cardiac rehabilitation (CR) improves outcomes for patients with cardiac disease but has an historically low participation rate. For socioeconomically disadvantaged patients experiencing challenges with access to care, participation can prove especially difficult. The ERA-Nudge trial aimed to evaluate the effect of choice of hospital or home-based CR and the effect of behavioral nudge messaging on participation and adherence in a diverse population of low socioeconomic status. This is the first report of patient characteristics from ERA-Nudge.Methods:ERA-Nudge was a pragmatic, randomized, controlled clinical trial using a 2×2 factorial design conducted at an urban safety net hospital in the US mountain west from 2019 to 2023. Patients were required to be eligible for CR, have a smartphone in order to use a mobile phone app, speak English or Spanish, and provide informed consent to participate in the study. At their baseline visit, patients were randomized to 1) choice of hospital or home-based CR with nudges; 2) choice of hospital or home-based CR alone; 3) hospital-based CR with nudges; 4) hospital-based CR alone. At study-required baseline, 6-week, and 12-week visits, clinical and lifestyle outcomes were assessed. Descriptive analyses were conducted on the characteristics of randomized patients.Results:Among 697 screened patients who were eligible for CR, 517 consented to participate. There were 70 patients who were not randomized (22 no showed for baseline visit; 2 died before randomization; 1 withdrew; 45 could not be re-contacted or did not provide a reason), resulting in 447 patients randomized in the study (Table 1) and 316 that completed the three study-required visits.Conclusions:ERA-Nudge was completed in a diverse, low-income, urban population, supporting the feasibility of evaluating smartphone and mobile app interventions in these patients. Not only did patients enroll, but most completed required study visits. Further analysis of the ERA-Nudge data will provide insight into how these patients responded to nudge-based mobile messaging, and whether having a choice to participate in CR at home impacted their overall CR adherence.Registration Number: NCT03834155
Abstract 4143017: Insights for Direct-to-Patient Clinical Trial Recruitment Strategies From the Heartline Study
Circulation, Volume 150, Issue Suppl_1, Page A4143017-A4143017, November 12, 2024. Background:Decentralized clinical trials using direct-to-participant recruitment can potentially engage large, representative participant pools.Research Question:Can a decentralized clinical trial use a multichannel approach to recruit patients >65 years old across the United States?Goals/Aims:To share insights on multichannel strategies for participant recruitment in the decentralized, app-based Heartline study.Methods:Heartline is a randomized trial testing the impact of a mobile app-based heart health program with the electrocardiogram (ECG) and Irregular Rhythm Notification (IRN) features on Apple Watch for early diagnosis, treatment, and outcomes of atrial fibrillation. Eligible participants were US adults aged ≥65 years with an iPhone and Medicare coverage. Multiple pathways for broad outreach were explored, including digital (eg, email, social media) and traditional channels (eg, direct mail, community outreach). Recruitment efforts were assessed and refined to reach a large eligible population.Results:A multichannel approach led to ~300,000 Heartline study app installations. In total, 34,244 participants completed enrollment (Feb 2020-Dec 2022), of whom 28,155 completed baseline demographic assessments. Participants were widely distributed geographically, with notable representation of outlying and rural areas (Figure 1). Women accounted for 54% of the participants. Overall, most participants were White (93.0%), with Asian, Black, and Hispanic participants representing 2.8%, 2.7%, and 2.5%, respectively.Conclusion:The Heartline study demonstrated the ability to recruit large numbers of participants aged ≥65 years using a direct-to-participant approach. Broad outreach strategies ensured gender and geographic diversity, enrolling a higher percentage of women than typical cardiology trials, and participation from rural areas. However, underrepresentation across racial/ethnic groups persisted and strategies to increase enrollment are needed. For similar trials, a strategic multichannel approach, with strong data and analytics capabilities may be beneficial to effectively target and enroll eligible participants.
Abstract 4146993: Anthracycline-based Chemotherapy in A Patient with Breast Cancer and Left-Ventricular Hypertrabeculation
Circulation, Volume 150, Issue Suppl_1, Page A4146993-A4146993, November 12, 2024. Introduction:Anthracyclines (AC), a class of chemotherapeutic drugs, are used to treat various cancers, including breast cancer (BC). However, AC cause dose-dependent cardiac toxicity. Practice guidelines list pre-existing cardiomyopathy as a risk factor for cancer therapy-related cardiac dysfunction (CTRCD), but there is a lack of data on cardiotoxicity risk in patients with left ventricular (LV) hypertrabeculation without LV hypertrophy/dilation. We present a patient with LV hypertrabeculation who developed LV dysfunction after AC chemotherapy for BC.Description of Case:A 55-year-old woman diagnosed with multicentric invasive ductal carcinoma (IDC) of the right breast, stage IIA (cT3 cN1 cM0), grade 2, ER+/PR+/HER2-, was treated with neoadjuvant Paclitaxel for 3 months. Before AC-based chemotherapy, stress cardiac MRI due to residual post-COVID-19 dyspnea showed LV hypertrabeculation with a non-compacted/compacted ratio of 2.3, LVEF 56%, and no delayed enhancement. Transthoracic echocardiography (TTE) reported an LVEF of 52% with GLS of -17%. The patient’s electrocardiogram (ECG) showed normal sinus rhythm, and NT-pro BNP levels were
Abstract 4146005: Cardiogenic Shock secondary to Acute Structural Valve Dysfunction of an Avalus Bioprosthesis in a Patient with Two Prior Valve Replacement Surgeries – Third Time’s the Charm
Circulation, Volume 150, Issue Suppl_1, Page A4146005-A4146005, November 12, 2024. Aortic valve replacement (AVR) with biological valve prostheses (BV) avoids long-term anticoagulation compared with mechanical vale prostheses. Their durability is limited due to structural valve dysfunction (SVD). Valve degeneration is gradual, leading to bioprosthetic valve failure (BVF). We present the first case reported of acute aortic Avalus bioprosthesis SVD with severe aortic regurgitation (AR) secondary to flail leaflet.A very active 52-year-old male with CAD, atrial fibrillation/flutter, and bicuspid aortic valve (AV) with symptomatic severe aortic stenosis treated with a 25 mm Abbott St. Jude/EPICTMSupra valve 16 years ago required a redo surgery for infective endocarditis with an aortic root abscess treated with a 25 mm Medtronic Avalus BV 5 years prior and aortic root reconstruction. He presented with a 3-day history of chest pain and severe dyspnea. On arrival, cardiogenic shock and respiratory failure ensued, requiring vasopressors and endotracheal intubation. CXR revealed pulmonary edema. Coronary angiogram revealed non-obstructive CAD. TEE revealed preserved LV function with severe acute AR. He underwent emergent AVR. Surgery revealed a sterile flail prosthetic valve leaflet with complete prolapse of the noncoronary cusp. A 27-mm Medtronic Evolute BV was placed. His course was complicated by transient complete heart block. He continued improving and was then discharged.Acute AR should be suspected in patients with acute hemodynamic instability and history of AVR. TTE or TEE are crucial for the assessment of BV and diagnosis of AR. The only effective treatment for acute severe AR is emergent AVR. Newer generation BVs offer the possibly of not requiring long-term anticoagulation and enhanced durability. The PERIGON trial evaluating the Avalus bioprosthesis in AVR showed no cases of SVD with excellent durability and hemodynamic profile during the 5-year follow-up, being this the first case reported in the literature of acute catastrophic failure of this valve.Our case highlights the importance of rapid diagnosis and intervention in acute aortic BVF. While newer BVs offer improved durability and hemodynamic properties, clinicians must remain vigilant for acute complications secondary to SVD. Studies with longer follow-up are needed to better characterize the safety and performance of the Avalus bioprosthesis. The lack of standardized definitions for SVD may have led to underreporting and underestimation of its incidence.