tbuckley/cabot-search huggingface dataset:
Abstract 4139306: Digital engagement with a patient smartphone app and text messaging is associated with increased compliance in patients undergoing long-term continuous ambulatory cardiac monitoring
Authors: Anthony Battisti, Joshua Raley, Alice Fan, Relana Pinkerton, Hardwin Mead, Mintu Turakhia
Journal: Circulation (2024)

Introduction: Although home-based diagnostics have dramatically reshaped care delivery, greater patient activation could affect compliance. For home enrollment and activation (HE) of long-term continuous ambulatory cardiac monitoring (LTCM) devices, patients must receive the device by mail, self-apply the patch, wear it for up to 14 days, and return by mail for ECG interpretation. We developed two direct-to-patient digital interventions and evaluated association of use of these to compliance outcomes after US-wide implementation. Methods: MyZio® is an optional smartphone app (iOS&amp;Android) for patients for use with Zio® LTCM (iRhythm Technologies, Inc; San Francisco, CA) that tracks shipping status, enables registration, provides educational content and instruction on application/activation/wear, notifies users of remaining wear time and gives return reminders. Patients with a mobile number may also opt-in to short messages services (SMS) text notifications. Opt-in patients receive texts regarding delivery, application/wear, billing information, device return and prompts to download MyZio. We evaluated patient compliance (activation, wear, and device return) in all patients shipped Zio LTCM with HE between Oct 1 and Apr 3, 2024; the period after launch of MyZio version 2.0. We calculated return rates, stratified by use of one or both digital interventions. Odds ratios were calculated and the Chi Square test was used to report associated p-values compared to the reference (no intervention). Results: The distribution of the use of digital tools and compliance outcomes in 169,131 patients are shown in Table 1. Compliance was lowest (74.6%) when both the app and text messaging were not used. App use was associated with the highest gains in compliance, largely irrespective of concomitant text messaging. Opting into SMS text was associated with compliance improvement but was inferior to app use. Conclusion: In patch-based ECG LTCM, a dedicated patient app and SMS texting were associated with improved device return rates, although the app had a stronger effect. These data support the use of patient digital health interventions in home-based diagnostics and underscore the importance of post-implementation evaluation of outcomes.
Abstract 4139206: Design of Heart-2: a phase 1b clinical trial of VERVE-102, an <i>in vivo</i> base editing medicine delivered by a GalNAc-LNP and targeting <i>PCSK9</i> to durably lower LDL cholesterol
Authors: Scott Vafai, Verena Karsten, Chelsey Jensen, Richard Falzone, Troy Lister, Leslie Stolz, Amit Khera, Sekar Kathiresan, Andrew Bellinger, Fred Fiedorek
Journal: Circulation (2024)

Introduction: Maintaining LDL-C at goal levels is critical in populations at high risk for cardiovascular events, including people with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD). Despite multiple approved LDL-C lowering therapies for these populations, most patients are not at guideline-directed treatment goal. In vivo base editing to inactivate hepatic PCSK9 has the potential to provide lifelong LDL-C lowering after a single course of treatment. Success of the base editing approach is contingent on safe and effective hepatocyte delivery and precise, consistent PCSK9 editing. Aim: We set out to develop a base editing medicine to inactivate PCSK9 with broad utility across diverse genetic backgrounds. Here we describe the investigational therapy, VERVE-102, and the design of the ongoing, phase 1b Heart-2 trial. Approach: VERVE-102 consists of an mRNA encoding an adenine base editor and guide RNA (gRNA) targeting PCSK9 packaged in a novel, proprietary GalNAc lipid nanoparticle (LNP). VERVE-102 creates a precise A-to-G DNA edit to introduce a premature stop codon and thereby inactivate PCSK9 in hepatocytes. In a DNA sequence analysis of 784,318 individuals from diverse ancestries, the 20 base-pair sequence targeted by the gRNA was identical in 99.97% of individuals. LNP delivery to hepatocytes in vivo occurs through either endogenous LDL receptor (LDLR) uptake or GalNAc-mediated endocytosis via the asialoglycoprotein receptor (ASGPR) and as such, may address the LDLR deficiency seen in a fraction of patients with HeFH. Heart-2 is a single ascending dose trial of VERVE-102 in males and females aged 18–65 with HeFH and/or premature CAD who require additional LDL-C lowering despite maximally tolerated oral lipid-lowering therapies. Participants receive a single intravenous infusion of VERVE-102 with 3 to 9 participants per dose cohort. The primary endpoint is safety and tolerability. Secondary endpoints include pharmacokinetics of VERVE-102 and changes from baseline in blood PCSK9 and LDL-C. Discussion: VERVE-102 was designed to access hepatocytes via either LDLR- or ASGPR-mediated uptake to enable robust LNP delivery and subsequent PCSK9 editing. Consistency of the gRNA target site suggests that potential therapeutic benefits should apply broadly across ancestries. The ongoing Heart-2 clinical trial is intended to support selection of a safe and effective dose for future clinical investigation of VERVE-102.
Abstract 4139226: Anticoagulation For Patients On Hemodialysis And Atrial Fibrillation
Authors: Ramin Ebrahimi, Carlos Alvarez, paul dennis
Journal: Circulation (2024)

Background: Anticoagulation is the standard treatment for the majority of patients with atrial fibrillation (AF) to reduce the risk of stroke. Anticoagulation is also utilized in patients with end-stage renal disease (ESRD) on hemodialysis (HD) who have AF. Such patients are at high risk for bleeding and stroke. However, limited data is available regarding utility of anticoagulation in such patients. The goal of this project was to assess the efficacy of anticoagulation to reduce the risk of stroke for patients with ESRD on HD who developed new onset AF. Methods: The national Veterans Affairs (VA) electronic health records were utilized to identify patients with ESRD on HD from 01/01/2000 to 01/01/2018. Those with AF prior to HD were excluded. In addition, those with stroke, mitral or aortic valve surgery prior to AF were excluded. Anticoagulants included warfarin, or apixaban, rivaroxaban, edoxaban and dabigatran, collectively termed DOACs. Patients were considered to be on an anticoagulation if they received anticoagulation for &gt;1 month. All diagnoses were based on International Classification of Disease (ICD) 9 th and 10 th versions, and Current Procedural Terminology codes. Follow up period extended from the onset of AF to 01/01/2020 or death. Results: Over the study period 12,559,292 patients visited any of the VAs nationally. Of these, 89,081 were on HD without prior AF. Of those, 17,192 (19.3%) developed new AF. Of these 13,649 had no stroke, mitral or aortic surgery prior to the AF diagnosis. Of the 9,227 patients in the no anticoagulation cohort, 476 patient subsequently had stroke (5.16%). Of the 3,708 warfarin treated patients, 533 had subsequent stroke (14.37). Of the 358 DOAC patients, 34 (9.95%) had subsequent stroke. The difference in the stroke rates between those anticoagulated and those not anticoagulated was significant (P&lt;0.01). Conclusions: These preliminary data reveal significant differences in the rate of stroke based on anticoagulation status, and potentially specific type of anticoagulation in HD patients with new onset AF. Further studies are indicated to assess both the safety and efficacy of anticoagulation in HD patients with new onset AF.
Abstract 4139492: Impact Of Valvular Heart Diseases On In Hospital Outcomes Of Patients With Immune Thrombocytopenic Purpura - A Nationwide Analysis
Authors: Jayalekshmi Jayakumar, Manasa Ginjupalli, Rohit Sekandlapuram, Mrunanjali Gaddam, Bhavyakumar Vachhani
Journal: Circulation (2024)

Background: There are multiple studies showing high prevalence of valvular heart diseases(VHD) in patients with Immune Thrombocytopenic Purpura(ITP) and the need for prompt pre-operative treatment while attempting surgical repair of valves. A reciprocal occurrence of high valvular complications in suboptimally treated ITP were also reported in literature. This could be multifactorial and can be attributed to increased platelet destruction from shear stress and turbulent flow from stenotic or regurgitant valves, increased platelet reactivity, acquired platelet dysfunction and dilutional effect. In this study, we tried to analyze the in-hospital outcomes of ITP in patients who have VHD. Methods: We queried the National inpatient sample 2016-2020 using ICD-10 codes to identify VHD hospitalizations(stenotic and regurgitant mitral, tricuspid, aortic and pulmonary valves). This population was stratified with the prevalence of ITP. Complication rates for bleeding, sepsis, pulmonary hypertension, infective endocarditis, acute embolic stroke and arrhythmia were compared in these cohorts using chi-square test. Multivariate regression analysis was further performed to study the impact of VHD on mortality, length of stay and total hospitalization charges in the subpopulation of ITP hospitalizations after adjusting for relevant confounders. Results: We identified 8,279,973 VHD hospitalizations with a mean age of 73.58 without ITP and 73.72 with ITP, of which 48.6 % were females. The prevalence of ITP in this subpopulation was 0.27%(N = 22, 995). As compared to ITP hospitalizations without VHD, hospitalizations with VHD had a statistically significant higher occurrence of epistaxis, hemoptysis, hematuria, gastrointestinal bleed, intracranial bleed, sepsis, pulmonary hypertension, arrhythmia and infective endocarditis(Table 1). In the subgroup of hospitalizations with ITP, multivariate regression analysis revealed higher odds of mortality, increased length of stay and higher hospital charges with VHD than those without VHD.(Table 2) Conclusion: Valvular heart diseases have significant impact on the in hospital outcomes of patients admitted with ITP. Considering the possibility of reciprocal influence, there is a further scope for prospective studies to establish bidirectional association which can give way to promising options to improve outcomes in patients with valvular heart disease who develop ITP and can also aid in pre-operative risk stratification for valvular surgeries
Abstract 4139481: Relationship between Iron Deficiency and Cardiovascular Health in Pediatric Patients with Fontan Circulation
Authors: Arushi Agrawal, Molly Weisert, Jon Detterich, John Wood, Andrew Cheng
Journal: Circulation (2024)

Background: The physiology of the Fontan circulation is consistent with chronic heart failure, characterized by elevated central venous pressure and reduced cardiac output. In adults with conventional heart failure, iron deficiency is common and is associated with increased morbidity and mortality. However, data is lacking on the prevalence of iron deficiency and its relationship with cardiovascular outcomes in pediatric patients with Fontan circulation. Aim: To characterize the relationship between iron profiles and measures of cardiovascular health in pediatric patients with Fontan circulation. Hypothesis: Iron deficiency is associated with worse measures of cardiovascular health. Methods: Cross-sectional study comprising patients with Fontan circulation who had iron labs measured from 2010 - 2024 at a single urban center. Exclusion criteria were hematologic disease other than iron deficiency, acute bleeding, and acute illness other than heart failure. Cardiovascular health was evaluated with NYHA or Ross class, echocardiogram, and cardiac MRI. Kruskal-Wallis tests and linear regression were used to analyze associations between iron labs and measures of cardiovascular health. Indexed oxygen delivery (iDO2) was calculated from cardiac index measured by cardiac MRI, pulse oximetry, and hemoglobin. Results: 100 patients (mean 12.5±4.7 years, 46% female) were included. Iron deficiency was present in 45% or 51% based on conventional criteria of transferrin saturation (TSAT) &lt;20% or ferritin &lt;30 ng/mL, and 94% based on suggested criteria for heart failure (ferritin &lt;100 ng/mL or ferritin 100-299 ng/mL and TSAT &lt;20%). TSAT was significantly lower in patients with NYHA or Ross class III/IV vs. I/II symptoms (median 14% [IQR 10-19%] vs. 20% [15-25.5%], p=0.014) and in those with history of ≥ moderate vs. &lt; moderate atrioventricular valve regurgitation (median 12.5% [10-21.8%] vs. 20.5% [15-24.5%], p=0.049). Ferritin trended toward being significantly lower in those with ≥ moderate vs. &lt; moderate ventricular dysfunction (median 19.5 [11-34] vs. 30.5 [18-56], p=0.095). Among patients with hemoglobin &lt;15 g/dL, TSAT strongly correlated with iDO2 (R 2 =0.495, p=0.034). Conclusion: Iron deficiency is common and is associated with both worse heart failure symptoms and objective measures of cardiovascular health in pediatric patients with Fontan circulation. Interventions to improve iron stores offer promising avenues for mitigating heart failure risk and improving outcomes.
Abstract 4138840: Hybrid Convergent Procedure as a ‘Bail Out’ Strategy In Patients with Atrial Fibrillation Resistant To Catheter Ablation
Authors: Remy Spring, Emma Playford, Aditya Eranki, Pragnesh Joshi, David Playford, Rukshen Weerasooriya
Journal: Circulation (2024)

Introduction: Atrial fibrillation (AF) is a common and symptomatic arrhythmia which can be resistant to conventional endocardial catheter ablation. The Hybrid Convergent procedure, combining initial surgical AF ablation with a concurrent or staged endocardial catheter-based component, offers a potential solution for refractory cases. While effective as a de novo treatment for persistent AF, outcomes of this procedure in patients who failed prior catheter ablation remains uncertain. Our aim was to evaluate its efficacy and safety in this patient group. Methods: We conducted a single-center retrospective cohort study involving consecutive patients selected for the Hybrid Convergent procedure between May 2019 and October 2022 at a single center in Perth, Western Australia. Eligible patients had symptomatic AF and failed prior catheter ablation and antiarrhythmic drugs. The primary outcome was single procedure freedom from atrial arrhythmias, on or off antiarrhythmic drugs at 12 months. Overall follow-up freedom from AF, 12-month AF burden, complications and reinterventions were also recorded. Results: Sixty-two patients underwent both stages of the Hybrid Convergent procedure. All received concomitant thoracoscopic left atrial appendage exclusion. Of these, 46 (74.2%) were male, 27 (45.3%) had paroxysmal AF, and 15 (24.2%) had implantable loop recorders (ILRs). The mean duration since AF diagnosis was 9.5±7.1 years, with a median of 3 prior catheter ablations for AF. The median follow-up was 25.9 (13-48) months. After 12 months, 36 (62.9%) patients remained free from any atrial arrhythmia (figure 1). At this time point, 47 (75.8%) patients had an atrial arrhythmia burden of less than 5%. For the overall follow-up period, 32 (51.6%) patients maintained freedom from any atrial arrhythmia. Among patients with ILRs, the 12 month atrial arrhythmia free survival was 36.6%, compared with 64.4% in those without ILRs. Nine patients required repeat catheter ablation. There was one major complication. Conclusions: Our initial experience with the Hybrid Convergent procedure demonstrates sustained effectiveness and safety for patients with paroxysmal or persistent AF who have previously failed catheter ablation strategies.
Abstract 4139423: Glycemic Changes After Peer Group Exergaming and Step Goal Activities Among Adolescents With Type 1 Diabetes
Authors: James Lukasik, Laura Nally, Sangchoon Jeon, Alvaro Granados, Stuart Weinzimer, Garrett Ash
Journal: Circulation (2024)

Adolescents with type 1 diabetes (T1D) experience both psychosocial and self-management barriers to physical activity (PA). We previously reported on a peer support intervention with group exergaming and step-counting goals for adolescents with T1D. The intervention yielded high participation, motivation, perceived group cohesion, and participant satisfaction. The purpose of the present sub-study was to assess 24hr continuous glucose monitoring (CGM) changes following the biweekly 20-40min group exergaming sessions (Nintendo Ring Fit Adventure) across the 6-week intervention, adjusted for other daily PA tracked by smartwatch (Fitbit Inspire 2). Participants (n=15) were mean age 15.6 [SE=0.4] years, 7 non-Hispanic white, 6 female, 1 non-binary, mean A1c 8.9%±0.6%. They provided 75.3% of possible 24hr CGM readings (n=12 Dexcom G6, n=3 Abbott Libre 2) and 70.5% of possible 24hr Fitbit readings, thus 1,008 person-hours with CGM and Fitbit. In a 2-level linear model (i.e., within-person biometrics from CGM and Fitbit, after adjustment for between-person HbA1c and age), hours ≤24hr after exergaming sessions - compared to hours &gt;24hr after them – had lower average glucose (185mg/dL [95% CI 173,196] vs 192mg/dL [177,214], t=-2.66, P &lt;.01) and higher probability of glucose being in the clinical target range of 70-180mg/dL (OR=1.18 [95% CI 1.06,1.32], t=2.98, P &lt;.01). Increased hourly Fitbit steps further contributed to lowering average glucose (standardized β=-0.65 (SE=0.11), t=-2.37, P &lt;.01) and increasing probability of being in the clinical target glucose range (β=0.021±0.003), t=6.26, P &lt;.01). Whereas, increased hourly Fitbit heart rate contributed to elevating average glucose (β=0.52±0.08), t=6.52, P &lt;.01) and decreasing likelihood of being in the clinical target glucose range (β=-0.012±0.002), t=-5.20, P &lt;.01). In conclusion, both peer group exergaming and Fitbit steps were followed by glucose being modestly lower and more often in the clinical target range, suggesting our intervention was an implementable strategy to aid in glucose management but may require increasing the volume of exercise. Fitbit heart rate elevations independent of PA may signal sympathetic nervous system activation (e.g., from mental stress) and partially predict elevation of glucose. Further research should test dose response to varying amounts of exergaming, refine the optimal time window duration after exergaming to observe glucose effects, and examine other CGM metrics.
Abstract 4139455: Do Congenital Heart Defects in Offspring Signal Early Signs of Maternal Cardiometabolic Dysregulation and Increased Risk of Cardiovascular Disease Later in Life?
Authors: Emine Bircan, Mohammed Orloff, Laura Hays, Jun Ying, Hari Eswaran, Wendy Nembhard
Journal: Circulation (2024)

Introduction: A recent study suggested an association between a history of delivering a child with congenital heart defects (CHDs) and development of cardiovascular diseases (CVDs) later in life; however, little is known about this possible association. Research Question: Do women with a CHD-affected pregnancy have a higher risk of CVD compared to women who had a pregnancy unaffected by a structural birth defect? Goals: To determine the CVD risk among women with a history of a CHD-affected pregnancy. Methods: A total of 1,423 women who delivered an infant with at least one of selected CHDs, and 1,020 women who delivered a live-born infant with no structural birth defects were identified from the Arkansas site of the National Birth Defects Prevention Study (August 1997 – December 2011) and linked to the Arkansas All-Payers Claims Database (2000-2022) to identify cases of CVD. CVD was identified using International Classification Diagnostic Ninth (ICD-9) and Tenth (ICD-10) codes and was categorized as ischemic, cerebrovascular, essential hypertension, other heart diseases, other CVDs, and any CVDs. Women were followed from the estimated date of delivery of their offspring (in years) until the date of the first CVD event, death, or the end of the study (January 1, 2023), whichever occurred first. Unadjusted and adjusted hazard ratios (aHR) with corresponding 95% confidence intervals (CIs) were calculated from Cox Proportional Hazard regression analyses. Results: Both adjusted and unadjusted models showed women with CHD-affected pregnancies had a higher risk of developing any type of CVD than those with no structural birth defects. Women with CHD-affected children had a 1.40 times risk of developing any type of CVD (aHR=1.4, 95% CI: 1.1, 1.8) after adjusting for potential confounders. For specific types of CVD, the risk was (aHR=3.7, 95% CI: 1.1, 13.1) for developing ischemic heart disease. Conclusion: Women with CHD-affected pregnancies have an increased risk of developing CVD in later life. CHD-affected pregnancies may be early signs of cardiometabolic dysregulation and CVD in later life. Additional studies are needed to further investigate this possible association.
Abstract 4138970: A Novel Cardiac Simulator "ped UT-Heart" to Support Decision-Making in Surgical Procedures for Complex Congenital Heart Disease
Authors: Isao Shiraishi, Kenichi Kurosaki, Shigemitsu Iwai, Takumi Washio, Seiryo Sugiura, Toshiaki Hisada
Journal: Circulation (2024)

Background: To support the surgical decision-making for complex congenital heart disease (CHD), a novel computer-based cardiac simulator called "ped UT-Heart" has been developed, in which a patient-specific finite element model simulates cardiac functions and predicts hemodynamics of different virtual surgeries. Objective: To validate the accuracy, usefulness, and safety of the “ped UT-Heart“ simulation system. Methods: First, retrospective validation studies of pre- and post-operative simulation (n=10) were performed by comparing virtual simulation data with real patient catheter data. Subsequently, a single-arm, prospective, multicenter clinical study (jRCTs052210139) was conducted in 16 patients with complex CHD (Table 1). The primary endpoint was defined as an overall rating of essential or very useful on a 5-point Likert scale. Results: Pre- and post-operative simulation data correlated well with patient catheter data (Figure 1). In the clinical trial, four patients were excluded due to delayed surgery, and the remaining 12 patients (median age, 2y8m) were assessed for usefulness. There were no adverse events associated with the simulation system. Nine of the twelve patients (&gt;60%) were rated as “Essential” or “Very useful“, and the lower limit of the 95% CI was 42.8% (&gt;30%), indicating that the results met the primary endpoint. As a representative case (ccTGA, 5y), the surgeon selected a double switch operation with VSD augmentation according to the post-operative simulation (Figure 2). The patient did well after the surgery with no significant hemodynamic problems. Conclusions: The "ped UT-Heart" is a safe, reliable, and useful cardiac simulator for supporting decisions of surgical procedures in complex CHD.