Journal Of The American College Of Cardiology[JOURNAL]

Edelson JB, O'Connor MJ, Shezad M … +16 more , Duganiero T, Auerbach SR, Bleiweis M, Dykes JC, Joong A, Khan S, Law S, Mokshagundam D, Ploutz M, Raskin A, Su J, Tunuguntla H, VanderPluym C, Villa C, Rosenthal DN, Lorts A

J Am Coll Cardiol · 2026 Jun · PMID 42089850 · Publisher ↗

BACKGROUND: Pediatric patients with heart failure increasingly rely on ventricular assist devices as a bridge to transplantation. The Berlin Heart EXCOR Pediatric is the only durable ventricular assist device specificall... BACKGROUND: Pediatric patients with heart failure increasingly rely on ventricular assist devices as a bridge to transplantation. The Berlin Heart EXCOR Pediatric is the only durable ventricular assist device specifically approved for infants and small children, but its IKUS driver limits mobility and quality of life. The EXCOR Active Driver was developed to address these limitations by improving mobility, battery life, and physiological adaptability. OBJECTIVES: This prospective, multicenter clinical trial evaluated the performance, safety, and clinical outcomes of a novel driving system in pediatric patients. METHODS: Forty subjects were enrolled under a U.S. Food and Drug Administration-approved investigational device exemption, followed by 118 additional patients under a continued access protocol. Primary endpoints included the incidence of major device malfunction, adverse events, and successful outcomes-defined as survival to transplantation, recovery, or continued support at 90 days postimplantation. Adjudication of adverse events was conducted by an independent Clinical Events Committee, with oversight provided by a Data Safety Monitoring Board. Outcomes were assessed using descriptive statistics and competing risk models. RESULTS: Among 40 investigational device exemption patients (mean age: 38.2 months; 55% with congenital heart disease), there were no episodes of major device malfunction. At 90 days, 65% remained on support, 17.5% had undergone transplantation, 15.0% were converted to another support modality, and 1 patient was explanted for recovery. Stroke incidence was 12.5%, and 90-day mortality rate was 0%. Among 118 continued access protocol patients, there were no major device malfunctions. At the time of data abstraction, 37% (n = 44) had undergone transplantation, 31% (n = 37) were alive on device, 6% (n = 7) had the device explanted for recovery, 23% (n = 27) had been converted to another support modality, and 3 patients had withdrawal of support. Survival at 90 days was 98.1%. CONCLUSIONS: This novel active driving system demonstrated excellent safety and reliability in a real-world, high-risk pediatric population, with no major device malfunctions. This trial also validates the feasibility of leveraging a clinical registry infrastructure for class III device evaluation, offering a scalable and cost-efficient model for device approvals.

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Digital Interventions For Postmyocardial Infarction Cardiac Anxiety: Treating an Unmet Need, But Are They Accessible?

Davis LL

J Am Coll Cardiol · 2026 May · PMID 42089490 · Publisher ↗

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On the Other Side of the Bed: An Ode to the Coronary Care Unit.

Krumholz HM

J Am Coll Cardiol · 2026 May · PMID 42089489 · Publisher ↗

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Automated Alerts to Improve Timely Evaluation and Treatment of Valvular Heart Disease: The ALERT Trial.

Batchelor WB, Lindman BR, Coylewright M … +13 more , Keller A, Wehman B, Chhatriwalla A, Patel SM, Stiver K, Zahr F, Sotelo M, Shin D, Rogers C, Hickey GL, Williams J, Fan M, Vemulapalli S

J Am Coll Cardiol · 2026 Jun · PMID 42059855 · Publisher ↗

BACKGROUND: Severe aortic stenosis (AS) and mitral regurgitation (MR) are frequently undertreated and characterized by persistent sex, racial and ethnic, socioeconomic, and geographic disparities despite effective valve... BACKGROUND: Severe aortic stenosis (AS) and mitral regurgitation (MR) are frequently undertreated and characterized by persistent sex, racial and ethnic, socioeconomic, and geographic disparities despite effective valve therapies. Whether automated electronic clinician notification (ECN) alerts improve the evaluation and treatment of AS and MR across health systems is unknown. OBJECTIVES: The purpose of this study was to evaluate whether ECN alerts improve guideline-directed evaluation and treatment of significant AS and MR across multiple health systems. METHODS: ALERT is a multisystem, cluster-randomized clinical trial including clinicians ordering echocardiograms across 5 U.S. health systems encompassing 35 hospitals between August 2024 and September 2025. Clinicians were randomized 1:1 to receive an ECN alert identifying significant AS or MR with accompanying care recommendations or to no alert with usual care. The primary endpoint was a hierarchical composite of time to surgical or transcatheter valve intervention, followed by time to multidisciplinary heart team clinic evaluation within 90 days, analyzed using the stratified win-ratio method. Secondary outcomes included individual components of the composite. RESULTS: A total of 765 clinicians ordering 2,016 echocardiograms were included. In the win-ratio analysis of the primary endpoint, ECN alert was superior to usual care (win ratio: 1.27; 95% CI: 1.05-1.54; P = 0.007), including higher rates of valve intervention (13.4% vs 9.6%; P = 0.005) and multidisciplinary heart team evaluation (22.7% vs 17.9%; P = 0.005) and shorter times to both endpoint components. Effect sizes were similar in AS (win ratio: 1.29) and MR patients (win ratio: 1.23). No evidence of heterogeneity was noted by valve pathology (P = 0.821) or across prespecified subgroups (age, sex, race, social deprivation index, inpatient vs outpatient setting, provider specialty, and rurality; P > 0.100 for all) and sensitivity analyses yielded consistent results across modified intention-to-treat, intention-to-treat, and per-protocol populations. CONCLUSIONS: In this multisystem cluster randomized trial, automated ECN alerts improved timely guideline-directed evaluation and valve intervention for clinically significant AS and MR. These findings suggest that electronic health record-integrated clinical decision support may represent a scalable strategy to reduce undertreatment and improve access to specialized valve care. (Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform; NCT06099665).

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Left Ventricular Noncompaction: Time to Retire a Flawed Diagnosis.

McGurk KA, Halliday BP, O'Regan DP

J Am Coll Cardiol · 2026 Jun · PMID 42053478 · Publisher ↗

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Clinical Documentation of an Individualized Emergency Action Plan for Young Athletes With Cardiovascular Conditions at Risk for Sudden Cardiac Arrest.

Quinn R, Petek BJ, Churchill TW … +8 more , Moulson N, Hsieh PN, Kliethermes SA, Thur L, Harmon KG, Baggish AL, Drezner JA, ORCCA Investigators and Steering Committee

J Am Coll Cardiol · 2026 Apr · PMID 42053477 · Publisher ↗

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From Insight to Infrastructure: Managing Cardiorespiratory Fitness.

Alter DA

J Am Coll Cardiol · 2026 Apr · PMID 42053476 · Publisher ↗

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Sudden Death From Pulmonary Embolism in National Collegiate Athletic Association Athletes: Insights From a 20-Year Registry.

Weller SL, Petek BJ, Churchill TW … +5 more , Moulson N, Baggish AL, Maleszewski JJ, Drezner JA, Harmon KG

J Am Coll Cardiol · 2026 Apr · PMID 42053475 · Publisher ↗

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The Unfinished Challenge of Chagas Cardiomyopathy: Lessons From Contemporary Heart Failure Trials.

Giordanino EF, Morillo CA

J Am Coll Cardiol · 2026 Jun · PMID 42053474 · Publisher ↗

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Limited Contribution of Fibrosis to Myocardial Interstitial Expansion in End-Stage Cardiac Amyloidosis: Insights From Explanted Whole Hearts.

Riefolo M, Sheikh A, Porcari A … +7 more , Di Sciascio L, Longhi S, Basso C, Cipriani A, Hawkins PN, Gillmore JD, Fontana M

J Am Coll Cardiol · 2026 Apr · PMID 42053473 · Publisher ↗

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Development and Validation of a Clinical Polygenic Risk Report in U.S.-Based Health Systems for 8 Cardiovascular Conditions.

Misra A, Jowell A, Haidermota S … +17 more , Perez E, Mahanta L, O'Brien KJ, Nagy A, Hao L, Truong B, Aragam K, Fahed AC, Khurshid S, Ellinor PT, Lewis ACF, Lennon N, Hornsby W, Lebo MS, Karlson EW, Natarajan P, Patel AP

J Am Coll Cardiol · 2026 Apr · PMID 42053472 · Publisher ↗

BACKGROUND: Polygenic risk scores (PRS) stratify inherited cardiovascular risk, but their path to clinical implementation remains unclear. OBJECTIVES: We aimed to develop and validate integrated PRS for 8 cardiovascular... BACKGROUND: Polygenic risk scores (PRS) stratify inherited cardiovascular risk, but their path to clinical implementation remains unclear. OBJECTIVES: We aimed to develop and validate integrated PRS for 8 cardiovascular conditions and outline a framework for their clinical reporting. METHODS: We analyzed genotype and clinical data from 245,394 All of Us Research Program participants. Publicly available PRS for 8 traits-coronary artery disease, atrial fibrillation, type 2 diabetes, venous thromboembolism (VTE), thoracic aortic aneurysm (TAA), extreme hypertension, severe hypercholesterolemia, and elevated lipoprotein(a)-were combined using PRSmix, an elastic-net approach. Integrated PRS were externally validated in 53,306 Mass General Brigham Biobank participants using logistic regression, adjusting for age, sex, and ancestry. RESULTS: Of 53,306 genotyped Mass General Brigham Biobank participants (55.6% women, mean age 53 ± 17 years), integrated PRS demonstrated robust discrimination and appropriate calibration across 8 cardiovascular traits. Comparing high genetic risk (top 10% of PRS distribution, or top 20% for rarer TAA and VTE) vs average risk (26th-75th percentiles, or 21st-80th percentiles for TAA and VTE) yielded ORs: coronary artery disease (3.7 [95% CI: 3.4-4.1]), type 2 diabetes (3.1 [95% CI: 2.8-3.3]), atrial fibrillation (3.0 [95% CI: 2.7-3.3]), VTE (1.9 [95% CI: 1.6-2.0]), TAA (1.7 [95% CI: 1.5-1.9]), hypertension (2.1 [95% CI: 1.8-2.3]), hypercholesterolemia (4.1 [95% CI: 3.7-4.5]), and lipoprotein(a) (41.0 [95% CI: 27.0-62.2]). Incorporating integrated PRS into clinical models improved risk classification, while prospective analyses confirmed significant associations with incident cardiovascular outcomes. CONCLUSIONS: Integrated PRS offer an implementable framework for genetic risk reporting, and are now available as a clinically orderable test. Broader prospective validation studies are needed to further establish clinical utility.

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Contemporary Trends in Percutaneous Coronary Intervention at Facilities Without On-Site Cardiac Surgery: Insights From the National Cardiovascular Data Registry.

Valle JA, Megaly M, Manandhar P … +4 more , Rymer JA, Wang T, Abbott JD, Grines CL

J Am Coll Cardiol · 2026 Apr · PMID 42053202 · Publisher ↗

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Journal Of The American College Of Cardiology[JOURNAL]

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