Faculty Bibliography

BACKGROUND:Accurate, timely ascertainment of clinical end points, particularly hospitalizations, is crucial for clinical trials. The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study extended the main TAILOR-PCI trial's follow-up to 2 years, using a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile phone surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations. OBJECTIVE:The objectives were to evaluate geofencing-triggered notifications and routine monthly mobile phone surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site. METHODS:US and Canadian participants from the TAILOR-PCI Digital Follow-Up Study were invited to download the Eureka Research Platform mobile app, opting in for location tracking using geofencing, triggering a smartphone-based survey if near a hospital for ≥4 hours. Participants were sent monthly notifications for CV hospitalization surveys. RESULTS:From 85 participants who consented to the Digital Study, downloaded the mobile app, and had not previously completed their final follow-up visit, 73 (85.8%) initially opted in and consented to geofencing. There were 9 CV hospitalizations ascertained by study coordinators among 5 patients, whereas 8 out of 9 (88.9%) were detected by routine monthly hospitalization surveys. One CV hospitalization went undetected by the survey as it occurred within two weeks of the previous event, and the survey only allowed reporting of a single hospitalization. Among these, 3 were also detected by the geofencing algorithm, but 6 out of 9 (66.7%) were missed by geofencing: 1 occurred in a participant who never consented to geofencing, while 5 hospitalizations occurred among participants who had subsequently turned off geofencing prior to their hospitalization. Geofencing-detected hospitalizations were ascertained within a median of 2 (IQR 1-3) days, monthly surveys within 11 (IQR 6.5-25) days, and site coordinator methods within 38 (IQR 9-105) days. The geofencing algorithm triggered 245 notifications among 39 participants, with 128 (52.2%) from true hospital presence and 117 (47.8%) from nonhospital health care facility visits. Additional geofencing iterative improvements to reduce hospital misidentification were made to the algorithm at months 7 and 12, elevating the rate of true alerts from 35.4% (55 true alerts/155 total alerts before month 7) to 78.7% (59 true alerts/75 total alerts in months 7-12) and ultimately to 93.3% (14 true alerts/5 total alerts in months 13-21), respectively. CONCLUSIONS:The monthly digital survey detected most CV hospitalizations, while the geofencing survey enabled earlier detection but did not offer incremental value beyond traditional tools. Digital tools could potentially reduce the burden on study coordinators in ascertaining CV hospitalizations. The advantages of timely reporting via geofencing should be weighed against the issue of false notifications, which can be mitigated through algorithmic refinements.

PURPOSE/OBJECTIVE:inhibitor therapy post PCI is safe in this population is unclear. METHODS:for CKD (n = 539) and non-CKD (n = 4276). The aggregate of cardiovascular death, stroke, myocardial infarction, stent thrombosis, and severe recurrent coronary ischemia at 12-months post-PCI was assessed as the primary endpoint. Secondary endpoint was major or minor bleeding. RESULTS:. Among all patients, there was no significant interaction between randomized strategy and CKD status for any endpoint. Among LOF carriers, the interaction between randomized strategy and CKD status on composite ischemic outcome was not significant (p = 0.2). GG strategy was not associated with an increased risk of bleeding in either CKD group. CONCLUSIONS:inhibitor escalation following a GG strategy was not associated with increased bleeding risk in CKD. Larger studies in CKD are needed. CLINICAL TRIAL REGISTRATION/BACKGROUND:https://clinicaltrials.gov/ct2/show/NCT01742117?term=TAILOR-PCI&draw=2&rank=1 . NCT01742117.

BACKGROUND:Managing percutaneous coronary intervention (PCI) patients with atrial fibrillation (AF) presents challenges given that there are several potential antithrombotic therapy (ATT) strategies. AIMS/OBJECTIVE:We examined ATT patterns, agreement between subjective physician ratings and validated risk scores, physician-patient perceptions influencing ATT and 1-year outcomes. METHODS:-VASc and HAS-BLED scores. Patients completed surveys regarding treatment understanding. Primary outcomes were 1-year major adverse cardiac or cerebrovascular events (MACCE: composite of death, myocardial infarction, definite/probable stent thrombosis, stroke, target lesion revascularisation) and actionable bleeding (Bleeding Academic Research Consortium 2, 3 or 5). RESULTS:The mean patient age was 73.2±9.0 years, including 25.8% females. Triple therapy (TT: 1 anticoagulant and 2 antiplatelet agents) was prescribed in 66.5%, dual antiplatelet therapy (DAPT) in 20.7% and dual therapy (1 anticoagulant+1 antiplatelet agent) in 12.8% of patients. Physician ratings and validated risk scores showed poor agreement (stroke: kappa=0.03; bleeding: kappa=0.07). Physicians rated bleeding-related safety (93.8%) as the main factor affecting ATT choice. Patients worried about stroke over bleeding (50.6% vs 14.8%). No group differences by ATT strategy were observed in 1-year MACCE (TT 14.1% vs dual therapy 12.7% vs DAPT 18.5%; p=0.25), or actionable bleeding (14.7% vs 7.9% vs 15.1%, respectively; p=0.89). CONCLUSIONS:The AVIATOR 2 study is the first digital health study examining physician-patient perspectives on ATT choices after AF-PCI. TT was the most common strategy without differences in 1-year outcomes in ATT strategy. Physicians rated safety first when prescribing ATT; patients feared stroke over bleeding. CLINICALTRIALS/RESULTS:gov: NCT02362659.

Aims/UNASSIGNED:We aimed to use optical coherence tomography (OCT) to identify differences in atherosclerotic culprit lesion morphology in women with myocardial infarction (MI) with non-obstructive coronary arteries (MINOCA) compared with MI with obstructive coronary artery disease (MI-CAD). Methods and results/UNASSIGNED:Women with an OCT-determined atherosclerotic aetiology of non-ST segment elevation (NSTE)-MINOCA (angiographic diameter stenosis <50%) who were enrolled in the multicentre Women's Heart Attack Research Program (HARP) study were compared with a consecutive series of women with NSTE-MI-CAD who underwent OCT prior to coronary intervention at a single institution. Atherosclerotic pathologies identified by OCT included plaque rupture, plaque erosion, intraplaque haemorrhage (IPH, a region of low signal intensity with minimum attenuation adjacent to a lipidic plaque without fibrous cap disruption), layered plaque (superficial layer with clear demarcation from the underlying plaque indicating early thrombus healing), or eruptive calcified nodule.We analysed 58 women with NSTE-MINOCA and 52 women with NSTE-MI-CAD. Optical coherence tomography features of underlying vulnerable plaque (thin-cap fibroatheroma) were less common in MINOCA (3 vs. 35%) than in MI-CAD. Intraplaque haemorrhage (47 vs. 2%) and layered plaque (31 vs. 12%) were more common in MINOCA than MI-CAD, whereas plaque rupture (14 vs. 67%), plaque erosion (8 vs. 14%), and calcified nodule (0 vs. 6%) were less common in MINOCA. The angle of ruptured cavity was smaller and thrombus burden was lower in MINOCA. Conclusion/UNASSIGNED:The prevalence of atherothrombotic culprit lesion subtype varied substantially between MINOCA and MI-CAD. A majority of culprit lesions in MINOCA had the appearance of IPH or layered plaque. Clinical Trial Registration Information/UNASSIGNED:

BACKGROUND:The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study is a novel proof-of-concept study that evaluated the feasibility of extending the TAILOR-PCI randomized controlled trial (RCT) follow-up period by using a remote digital platform. OBJECTIVE:The aim of this study is to describe patients' onboarding, engagement, and results in a digital study after enrollment in an RCT. METHODS:In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app. Those who did not respond to the letter were contacted by phone to survey the reasons for nonparticipation. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard patients, obtain consent, and administer activities in the digital study. The patients were asked to complete health-related surveys and digitally provide follow-up data. Our primary end points were the consent rate, the duration of participation, and the monthly activity completion rate in the digital study. The hypothesis being tested was formulated before data collection began. RESULTS:After the parent trial was completed, letters were mailed to 907 eligible patients (representing 18.8% [907/4837] of total enrolled in the RCT) within 15.6 (SD 5.2) months of randomization across 24 sites. Among the 907 patients invited, 290 (32%) visited the study website and 110 (12.1%) consented-40.9% (45/110) after the letter, 33.6% (37/110) after the first phone call, and 25.5% (28/110) after the second call. Among the 47.4% (409/862) of patients who responded, 41.8% (171/409) declined to participate because of a lack of time, 31.2% (128/409) declined because of the lack of a smartphone, and 11.5% (47/409) declined because of difficulty understanding what was expected of them in the study. Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P<.001). A greater proportion had bachelor's degrees (47.2% vs 25.7%; P<.001) and were more computer literate (90.5% vs 62.3% of daily internet use; P<.001) than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9% (SD 7.6%); there was no decrease in this rate throughout the study duration. CONCLUSIONS:Extended follow-up after enrollment in an RCT by using a digital study was technically feasible but was limited because of the inability to contact most eligible patients or a lack of time or access to a smartphone. Among the enrolled patients, most completed the required electronic visits. Enhanced recruitment methods, such as the introduction of a digital study at the time of RCT consent, smartphone provision, and robust study support for onboarding, should be explored further. TRIAL REGISTRATION/BACKGROUND:Clinicaltrails.gov NCT01742117; https://clinicaltrials.gov/ct2/show/NCT01742117.

BACKGROUND:Participation in ambulatory cardiac rehabilitation remains low, especially among older adults. Although mobile health cardiac rehabilitation (mHealth-CR) provides a novel opportunity to deliver care, age-specific impairments may limit older adults' uptake, and efficacy data are currently lacking. OBJECTIVE:This study aims to describe the design of the rehabilitation using mobile health for older adults with ischemic heart disease in the home setting (RESILIENT) trial. METHODS:RESILIENT is a multicenter randomized clinical trial that is enrolling patients aged ≥65 years with ischemic heart disease in a 3:1 ratio to either an intervention (mHealth-CR) or control (usual care) arm, with a target sample size of 400 participants. mHealth-CR consists of a commercially available mobile health software platform coupled with weekly exercise therapist sessions to review progress and set new activity goals. The primary outcome is a change in functional mobility (6-minute walk distance), which is measured at baseline and 3 months. Secondary outcomes are health status, goal attainment, hospital readmission, and mortality. Among intervention participants, engagement with the mHealth-CR platform will be analyzed to understand the characteristics that determine different patterns of use (eg, persistent high engagement and declining engagement). RESULTS:As of December 2021, the RESILIENT trial had enrolled 116 participants. Enrollment is projected to continue until October 2023. The trial results are expected to be reported in 2024. CONCLUSIONS:The RESILIENT trial will generate important evidence about the efficacy of mHealth-CR among older adults in multiple domains and characteristics that determine the sustained use of mHealth-CR. These findings will help design future precision medicine approaches to mobile health implementation in older adults. This knowledge is especially important in light of the COVID-19 pandemic that has shifted much of health care to a remote, internet-based setting. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT03978130; https://clinicaltrials.gov/ct2/show/NCT03978130. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:DERR1-10.2196/32163.

BACKGROUND/PURPOSE/OBJECTIVE:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as a highly contagious and lethal virus, devastating healthcare systems throughout the world. Following a period of stability, the coronavirus disease 2019 (COVID-19) pandemic appears to be re-intensifying globally. As the virus continues to evolve, so does our understanding of its implications on ST-segment elevation myocardial infarction (STEMI). We sought to describe a single center STEMI experience at one of the epicenters during the COVID-19 pandemic. METHODS/MATERIALS/METHODS:We conducted a retrospective, observational study comparing STEMI patients during the pandemic period (March 1, 2020 to August 31, 2020) to those with STEMI during the pre-pandemic period (March 1, 2019 to August 31, 2019) at NYU Langone Hospital - Long Island, a tertiary care center in Nassau County, New York. Additionally, we describe our subset of COVID-19 patients with STEMI during the pandemic. RESULTS:The acute myocardial infarction (AMI) team was activated for a total of 183 patients during both periods. There were a similar number of AMI team activations during the pandemic period (n = 93) compared to the pre-pandemic period (n = 90). Baseline characteristics did not differ during both periods however, infection control measures and additional investigation were required to clarify the diagnosis during the pandemic, resulting in a signal towards longer door-to-balloon times (95.9 min vs. 74.4 min, p = 0.0587). We observed similar inpatient length of stay (LOS) (3.6 days vs. 5.0 days, p = 0.0901) and mortality (13.2% vs. 9.2%, p = 0.5876). There was a total of 6 COVID-19 positive patients who presented with STEMI, of which 4 were emergently taken to the cardiac catheterization laboratory with successful percutaneous coronary intervention (PCI) performed in 3 patients. The 2 patients who were not offered primary PCI expired, as both were treated medically, one with thrombolytics. CONCLUSIONS:Our single center study, in New York, at one of the epicenters of the pandemic, demonstrated a similar number of AMI team activations, mimicking the seasonal variability seen in 2019, but with a signal towards longer door-to-balloon time. Despite this, inpatient LOS and mortality remained similar.

Background: Mobile health cardiac rehabilitation (mHealth-CR) may improve outcomes among older adults with ischemic heart disease, but variable engagement is not yet understood. We therefore analyzed preliminary data from the RESILIENT trial, an ongoing randomized trial of mHealth-CR vs. usual care in patients age >= 65.
Method(s): Data from the first 50 intervention participants were analyzed. Weekly engagement was scored from 0-11 based on exercise completion, therapist communication, video viewing, and BP self-measurement. Participants were classified as high or low engagement based on median engagement scores. Groups were compared by age, sex, social support (living alone), depression (PHQ-8), and Charlson Comorbidity Index (CCI).
Result(s): There was widely varying engagement with mHealth-CR that ranged from nearly zero to nearly perfect engagement (Figure). There were no significant differences between high and low engagement groups based on mean age (72.6 vs. 72.8, P=0.8), sex (76% male vs. 80%, P=0.7), living alone (28% vs. 44%, P=0.2), depression (mean 3.9 vs. 4.6, P=0.5), or comorbidity burden (mean 4.4 vs. 4.8, P=0.3), although the sample size was small.
Conclusion(s): Our early findings show wide variation in mHealth-CR engagement among older adults

Background: Following a period of stability, the coronavirus disease 2019 (COVID-19) pandemic appears to be re-intensifying globally. As the pandemic continues to evolve, so does our understanding of its implications on ST-segment elevation myocardial infarction (STEMI). We sought to describe a single center STEMI experience at one of the epicenters of the COVID-19 pandemic.
Method(s): This was a retrospective observational study which included consecutive suspected STEMI patients from March 1 through August 31, 2019, (Cohort 1) compared to the same time period in 2020 (Cohort 2), at a tertiary referral center in Nassau County, New York.
Result(s): Cohort 2 (n=93) saw a similar number of acute myocardial infarction (AMI) team activations compared to cohort 1 (n=90) (Figure 1). Infection control measures and additional investigation were required to clarify the diagnosis in cohort 2, resulting in longer door-to-balloon times (95.9 minutes vs. 74.4 minutes, p=0.0587). We observed similar inpatient length of stay (LOS) (3.6 days vs. 5.0 days, p=0.0901) and mortality (13.2% vs. 9.2%, p=0.5876).
Conclusion(s): Our single-center study, located at one of the epicenters of the pandemic, demonstrated a similar number of AMI team activations, mimicking the seasonal variability seen in 2019, but with longer door-to-balloon times. Despite this, inpatient LOS and mortality remained unchanged. [Formula presented]
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Background: Myocardial infarction with non-obstructive coronary arteries (MINOCA) occurs in 6-15% of MI and disproportionately affects women. Scientific statements recommend multi-modality imaging in MINOCA to define the underlying cause. We performed coronary optical coherence tomography (OCT) and cardiac magnetic resonance imaging (CMR) to assess mechanisms of MINOCA. Methods: In this prospective, multicenter, international, observational study, we enrolled women with a clinical diagnosis of MI. If invasive coronary angiography revealed <50% stenosis in all major arteries, multi-vessel OCT was performed, followed by CMR (cine imaging, late gadolinium enhancement, and T2-weighted imaging and/or T1 mapping). Angiography, OCT, and CMR were evaluated at blinded, independent core laboratories. Culprit lesions identified by OCT were classified as definite or possible. The CMR core laboratory identified ischemia-related and non-ischemic myocardial injury. Imaging results were combined to determine the mechanism of MINOCA, when possible. Results: Among 301 women enrolled at 16 sites, 170 were diagnosed with MINOCA, of whom 145 had adequate OCT image quality for analysis; 116 of these underwent CMR. A definite or possible culprit lesion was identified by OCT in 46.2% (67/145) of participants, most commonly plaque rupture, intra-plaque cavity or layered plaque. CMR was abnormal in 74.1% (86/116) of participants. An ischemic pattern of CMR abnormalities (infarction or myocardial edema in a coronary territory) was present in 53.4% of participants undergoing CMR (62/116). A non-ischemic pattern of CMR abnormalities (myocarditis, takotsubo syndrome or non-ischemic cardiomyopathy) was present in 20.7% (24/116). A cause of MINOCA was identified in 84.5% of the women with multi-modality imaging (98/116), higher than with OCT alone (p<0.001) or CMR alone (p=0.001). An ischemic etiology was identified in 63.8% of women with MINOCA (74/116), a non-ischemic etiology was identified in 20.7% (24/116), and no mechanism was identified in 15.5% (18/116). Conclusions: Multi-modality imaging with coronary OCT and CMR identified potential mechanisms in 84.5% of women with a diagnosis of MINOCA, three-quarters of which were ischemic and one-quarter of which were non-ischemic, alternate diagnoses to MI. Identification of the etiology of MINOCA is feasible and has the potential to guide medical therapy for secondary prevention. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02905357.