Artificial Intelligence in Cardiovascular Care - Part 2: Applications: JACC Review Topic of the Week.

Recent Artificial Intelligence (AI) advancements in cardiovascular care offer potential enhancements in effective diagnosis, treatment, and outcomes. Over 600 Food and Drug Administration (FDA)-approved clinical AI algorithms now exist, with 10% focusing on cardiovascular applications, highlighting the growing opportunities for AI to augment care. This review discusses the latest advancements in the field of AI, with a particular focus on the utilization of multimodal inputs and the field of generative AI. Further discussions in this review involve an approach to understanding the larger context in which AI-augmented care may exist, and include a discussion of the need for rigorous evaluation, appropriate infrastructure for deployment, ethics and equity assessments, regulatory oversight, and viable business cases for deployment. Embracing this rapidly evolving technology while setting an appropriately high evaluation benchmark with careful and patient-centered implementation will be crucial for cardiology to leverage AI to enhance patient care and the provider experience.

Artificial Intelligence for Cardiovascular Care - Part 1: Advances: JACC Review Topic of the Week.

Recent AI advancements in cardiovascular care offer potential enhancements in diagnosis, treatment, and outcomes. Innovations to date focus on automating measurements, enhancing image quality, and detecting diseases using novel methods. Applications span wearables, electrocardiograms, echocardiography, angiography, genetics, and more. AI models detect diseases from electrocardiograms at accuracy not previously achieved by technology or human experts, including reduced ejection fraction, valvular heart disease, and other cardiomyopathies. However, AI's unique characteristics necessitates rigorous validation by addressing training methods, real-world efficacy, equity concerns, and long-term reliability. Despite an exponentially growing number of studies in cardiovascular AI, trials showing improvement in outcomes remain lacking. A number are currently underway. Embracing this rapidly evolving technology while setting a high evaluation benchmark will be crucial for cardiology to leverage AI to enhance patient care and the provider experience.

Advancing Wearable Biosensors for Congenital Heart Disease: Patient and Clinician Perspectives: A Science Advisory From the American Heart Association.

Wearable biosensors (wearables) enable continual, noninvasive physiologic and behavioral monitoring at home for those with pediatric or congenital heart disease. Wearables allow patients to access their personal data and monitor their health. Despite substantial technologic advances in recent years, issues with hardware design, data analysis, and integration into the clinical workflow prevent wearables from reaching their potential in high-risk congenital heart disease populations. This science advisory reviews the use of wearables in patients with congenital heart disease, how to improve these technologies for clinicians and patients, and ethical and regulatory considerations. Challenges related to the use of wearables are common to every clinical setting, but specific topics for consideration in congenital heart disease are highlighted.

Promises and Perils of Consumer Mobile Technologies in Cardiovascular Care: JACC Scientific Statement.

Direct-to-consumer (D2C) wearables are becoming increasingly popular in cardiovascular health management because of their affordability and capability to capture diverse health data. Wearables may enable continuous health care provider-patient partnerships and reduce the volume of episodic clinic-based care (thereby reducing health care costs). However, challenges arise from the unregulated use of these devices, including questionable data reliability, potential misinterpretation of information, unintended psychological impacts, and an influx of clinically nonactionable data that may overburden the health care system. Further, these technologies could exacerbate, rather than mitigate, health disparities. Experience with wearables in atrial fibrillation underscores these challenges. The prevalent use of D2C wearables necessitates a collaborative approach among stakeholders to ensure effective integration into cardiovascular care. Wearables are heralding innovative disease screening, diagnosis, and management paradigms, expanding therapeutic avenues, and anchoring personalized medicine.

Use of a mixed reality system for navigational mapping during cardiac electrophysiological testing does not prolong case duration: A subanalysis from the Cardiac Augmented REality study.

Background: CommandEP™ is a mixed reality (MXR) system for cardiac electrophysiological (EP) procedures that provides a real-time 3-dimensional digital image of cardiac geometry and catheter locations. In a previous study, physicians using the system demonstrated improved navigational accuracy. This study investigated the impact of the CommandEP system on EP procedural times compared to the standard-of-care electroanatomic mapping system (EAMS) display. Objective: The purpose of this retrospective case-controlled analysis was to evaluate the impact of a novel MXR interface on EP procedural times compared to a case-matched cohort. Methods: Cases from the Cardiac Augmented REality (CARE) study were matched for diagnosis and weight using a contemporary cohort. Procedural time was compared from the roll-in and full implementation cohort. During routine EP procedures, operators performed tasks during the postablation waiting phase, including creation of cardiac geometry and 5-point navigation under 2 conditions: (1) EAMS first; and (2) CommandEP. Results: From a total of 16 CARE study patients, the 10 full implementation patients were matched to a cohort of 20 control patients (2 controls:1 CARE, matched according to pathology and age/weight). No statistical difference in total case times between CARE study patients vs control group (118 ± 29 minutes vs 97 ± 20 minutes; P = .07) or fluoroscopy times (6 ± 4 minutes vs 7 ± 6 minutes; P = .9). No significant difference in case duration for CARE study patients comparing roll-in vs full-implementation cohort (121 ± 26 minutes vs 118 ± 29 minutes; P = .96). CommandEP wear time during cases was significantly longer in full implementation cases (53 ± 24 minutes vs 24 ± 5 minutes; P = .0009). During creation of a single cardiac geometry, no significant time difference was noted between CommandEP vs EAMS (284 ± 45 seconds vs 268 ± 43 seconds; P = .1) or fluoroscopy use (9 ± 19 seconds vs 6 ± 18 seconds; P = .25). During point navigation tasks, there was no difference in total time (CommandEP 31 ± 14 seconds vs EAMS 28 ± 15 seconds; P = .16) or fluoroscopy time (CommandEP 0 second vs EAMS 0 second). Conclusion: MXR did not prolong overall procedural time compared to a matched cohort. There was no prolongation in study task completion time. Future studies with experienced CommandEP users directly assessing procedural time and task completion time in a randomized study population would be of interest.

Early preclinical experience of a mixed reality ultrasound system with active GUIDance for NEedle-based interventions: The GUIDE study.

Background: Use of ultrasound (US) to facilitate vascular access has increased compared to landmark-based procedures despite ergonomic challenges and need for extrapolation of 2-dimensional images to understand needle position. The MantUS™ system (Sentiar, Inc.,) uses a mixed reality (MxR) interface to display US images and integrate real-time needle tracking. Objective: The purpose of this prospective preclinical study was to evaluate the feasibility and usability of MantUS in a simulated environment. Methods: Participants were recruited from pediatric cardiology and critical care. Access was obtained in 2 vascular access training models: a femoral access model and a head and neck model for a total of 4 vascular access sites under 2 conditions-conventional US and MantUS. Participants were randomized for order of completion. Videos were obtained, and quality of access including time required, repositions, number of attempts, and angle of approach were quantified. Results: Use of MantUS resulted in an overall reduction in number of needle repositions (P = .03) and improvement in quality of access as measured by distance (P <.0001) and angle of elevation (P = .006). These findings were even more evident in the right femoral vein (RFV) access site, which was a simulated anatomic variant with a deeper more oblique vascular course. Use of MantUS resulted in faster time to access (P = .04), fewer number of both access attempts (P = .02), and number of needle repositions (P <.0001) compared to conventional US. Postparticipant survey showed high levels of usability (87%) and a belief that MantUS may decrease adverse outcomes (73%) and failed access attempts (83%). Conclusion: Use of MantUS improved vascular access among all comers, including the quality of access. This improvement was even more notable in the vascular variant (RFV). MantUS readily benefited users by providing improved spatial understanding. Further development of MantUS will focus on improving user interface and experience, with larger clinical usage and in-human studies.

A Single-center Experience Comparing First- Versus Second-generation Insertable Cardiac Monitors in Pediatric Patients.

Insertable cardiac monitors (ICMs) have undergone advancements in size and functionality over the past decade, resulting in the introduction of small, easily insertable devices capable of long-term remote monitoring. We define first-generation ICMs as implantable cardiac monitoring devices that require an incision and surgical creation of a subcutaneous pocket and second-generation ICMs as devices implanted using a custom-made tool for subcutaneous insertion, respectively. The aim of this study was to understand the differences between first- and second-generation pediatric ICM implants, implant indications, and time to diagnosis. We performed a retrospective, single-center chart review of patients who underwent ICM implantation from 2009-2019, spanning a 5-year course of first-generation ICM implantations and 5-year course of second-generation ICM implantations. Demographic data, past medical history, implant indication, and time to diagnosis were obtained. A total of 208 patients were identified over the 10-year time period, including 38 (18%) who underwent implantation with a first-generation device and 170 (82%) who underwent implantation with a second-generation device. Implant indications for first-generation ICMs included syncope (71%), palpitations (16%), inherited arrhythmia syndrome (IAS) management (5%), and premature ventricular contractions/ventricular tachycardia (VT) (8%); implant indications for second-generation ICMs included syncope (48%), palpitations (19%), IAS management (40%), premature ventricular contractions/VT (11%), atrial fibrillation (2%), tachycardia (3%), and heart block (0.5%). The average time to diagnosis was 38 weeks for patients with first-generation devices and 55 weeks for those with second-generation devices. With innovations in ICM technologies, there are expanding indications for ICM implantation in pediatric patients for long-term monitoring, specifically regarding the management of IAS patients.

Implementation and early experience of a pediatric electrophysiology telehealth program.

Background: Telehealth (TH) visits have been growing with exponential increased utilization during the COVID-19 pandemic. The aim of this manuscript is to describe the implementation and early experience of a pediatric electrophysiology (EP) TH program implemented during the pandemic, assessing patient satisfaction, patient equity and inclusion (measured by geographical outreach), and sustainability. Methods: A retrospective chart review study was performed and data were collected from the medical record, including demographic, testing, and billing data from scheduled TH encounters between March and August 2020 of a single pediatric EP group in the Midwest. Patients were called to complete satisfaction surveys. Results: Patients with diverse pathologies were seen in TH, with supraventricular/atrial tachycardias (n = 41, 35%) and inherited arrhythmia syndromes (n = 23, 20%) being most common. The mean distance from clinic was 95 miles (range 2.8-320 miles), with 43% of patients living more than 100 miles away from clinic. A total of 172 tests were performed previsit (n = 102, 59%), during the visit (n = 17, 10%), or postvisit (n = 53, 31%), including 15 EP studies. Time-based Current Procedural Terminology codes were predominantly used for billing purposes (n = 92, 78%). There was generation of work relative value units (wRVU) for visits (220.5 wRVU) and testing (325.1 wRVU). Survey data demonstrated that 98% of patients were satisfied with their telehealth appointment and 99% had a clear understanding of their diagnosis. Conclusion: Pediatric EP TH clinics can provide care for a geographically and pathologically heterogeneous group of patients who had positive attitudes toward TH. Our study shows significant downstream testing and subsequent wRVU generation, suggesting financial sustainability.

IV Sotalol Use in Pediatric and Congenital Heart Patients: A Multicenter Registry Study.

Background There is limited information regarding the clinical use and effectiveness of IV sotalol in pediatric patients and patients with congenital heart disease, including those with severe myocardial dysfunction. A multicenter registry study was designed to evaluate the safety, efficacy, and dosing of IV sotalol. Methods and Results A total of 85 patients (age 1 day-36 years) received IV sotalol, of whom 45 (53%) had additional congenital cardiac diagnoses and 4 (5%) were greater than 18 years of age. In 79 patients (93%), IV sotalol was used to treat supraventricular tachycardia and 4 (5%) received it to treat ventricular arrhythmias. Severely decreased cardiac function by echocardiography was seen before IV sotalol in 7 (9%). The average dose was 1 mg/kg (range 0.5-1.8 mg/kg/dose) over a median of 60 minutes (range 30-300 minutes). Successful arrhythmia termination occurred in 31 patients (49%, 95% CI [37%-62%]) with improvement in rhythm control defined as rate reduction permitting overdrive pacing in an additional 18 patients (30%, 95% CI [19%-41%]). Eleven patients (16%) had significant QTc prolongation to >465 milliseconds after the infusion, with 3 (4%) to >500 milliseconds. There were 2 patients (2%) for whom the infusion was terminated early. Conclusions IV sotalol was safe and effective for termination or improvement of tachyarrhythmias in 79% of pediatric patients and patients with congenital heart disease, including those with severely depressed cardiac function. The most common dose, for both acute and maintenance dosing, was 1 mg/kg over ~60 minutes with rare serious complications.

Single-Centre Case Series Assessment of Early Exercise Capacity Data Among Patients Who Received an Alterra Prestent and SAPIEN 3 Valve Placement.

Previous studies have used cardiopulmonary exercise test (CPET) data to objectively assess physiological changes in patients undergoing percutaneous pulmonary valve implantation. A retrospective review was performed to assess pre- and post-CPET data among patients undergoing Alterra Adaptive Prestent and SAPIEN 3 transcatheter heart valve (Alterra) placement. Of the 7 patients eligible for the study, 5 (71%) were male. The mean age was 22 years (range: 12-49 years). CPET data showed significant (P = 0.03) improvement in ventilatory efficiency (VE/VCO2) while only 2 (29%) patients had an improvement of percent predicted peak oxygen consumption (VO2). These findings suggest favourable haemodynamic changes though further investigation is needed.

Des résultats aux épreuves d'effort cardiorespiratoire ont été utilisés lors d'études antérieures pour mesurer de manière objective les changements physiologiques chez les patients ayant subi l'implantation percutanée d'une valvule pulmonaire. Nous présentons une étude rétrospective des résultats à ces épreuves avant et après l'intervention dans des cas d'implantation transcathéther d'une prothèse Alterra Adaptive Prestent et d'une valve cardiaque SAPIEN 3 (Alterra). Parmi les sept patients admissibles à l'étude, cinq (71 %) étaient de sexe masculin. L'âge moyen des sujets était de 22 ans (plage de 12 à 49 ans). Les résultats obtenus à l'épreuve d'effort cardiorespiratoire ont démontré une amélioration significative (P = 0,03) de l'efficacité respiratoire (VE/VCO2), mais seulement deux patients (29 %) ont présenté une amélioration du pourcentage prévu de la consommation maximale d'oxygène (VO2). Bien que ces observations semblent indiquer des changements hémodynamiques favorables, d'autres études sont nécessaires pour élucider la question.

Assessment of Apple Watch Series 6 pulse oximetry and electrocardiograms in a pediatric population.

BACKGROUND: Recent technologic advances have resulted in increased development and utilization of direct-to-consumer cardiac wearable devices with various functionality. This study aimed to assess Apple Watch Series 6 (AW6) pulse oximetry and electrocardiography (ECG) in a cohort of pediatric patients. METHODS: This single-center, prospective study enrolled pediatric patients ≥ 3kg and having an ECG and/or pulse oximetry (SpO2) as part of their planned evaluation. Exclusion criteria: 1) non-English speaking patients and 2) patients in state custody. Simultaneous tracings were obtained for SpO2 and ECG with concurrent standard pulse oximeter and 12-lead ECG. AW6 automated rhythm interpretations were compared to physician over-read and categorized as accurate, accurate with missed findings, inconclusive (automated interpretation: "inconclusive"), or inaccurate. RESULTS: A total of 84 patients were enrolled over a 5-week period. 68 patients (81%) were placed into the SpO2 and ECG arm, with 16 patients (19%) placed into the SpO2 only arm. Pulse oximetry data was successfully collected in 71/84 (85%) patients and ECG data in 61/68 (90%). ΔSpO2 between modalities was 2.0±2.6% (r = 0.76). ΔRR was 43±44msec (r = 0.96), ΔPR 19±23msec (r = 0.79), ΔQRS 12±13msec (r = 0.78), and ΔQT 20±19msec (r = 0.9). The AW6 automated rhythm analysis yielded a 75% specificity and found: 1) 40/61 (65.6%) "accurate", 2) 6/61 (9.8%) "accurate with missed findings", 3) 14/61 (23%) "inconclusive", and 4) 1/61 (1.6%) incorrect. CONCLUSION: The AW6 can accurately measure oxygen saturation when compared to hospital pulse oximeters in pediatric patients and provide good quality single lead ECGs that allow for accurate measurement of RR, PR, QRS, and QT intervals with manual interpretation. The AW6-automated rhythm interpretation algorithm has limitations for smaller pediatric patients and patients with abnormal ECGs.

2021 PACES expert consensus statement on the indications and management of cardiovascular implantable electronic devices in pediatric patients: Executive summary.

Guidelines for the implantation of cardiac implantable electronic devices (CIEDs) have evolved since publication of the initial ACC/AHA pacemaker guidelines in 1984 [1]. CIEDs have evolved to include novel forms of cardiac pacing, the development of implantable cardioverter defibrillators (ICDs) and the introduction of devices for long term monitoring of heart rhythm and other physiologic parameters. In view of the increasing complexity of both devices and patients, practice guidelines, by necessity, have become increasingly specific. In 2018, the ACC/AHA/HRS published Guidelines on the Evaluation and Management of Patients with Bradycardia and Cardiac Conduction Delay [2], which were specific recommendations for patients >18 years of age. This age-specific threshold was established in view of the differing indications for CIEDs in young patients as well as size-specific technology factors. Therefore, the following document was developed to update and further delineate indications for the use and management of CIEDs in pediatric patients, defined as ≤21 years of age, with recognition that there is often overlap in the care of patents between 18 and 21 years of age. This document is an abbreviated expert consensus statement (ECS) intended to focus primarily on the indications for CIEDs in the setting of specific disease/diagnostic categories. This document will also provide guidance regarding the management of lead systems and follow-up evaluation for pediatric patients with CIEDs. The recommendations are presented in an abbreviated modular format, with each section including the complete table of recommendations along with a brief synopsis of supportive text and select references to provide some context for the recommendations. This document is not intended to provide an exhaustive discussion of the basis for each of the recommendations, which are further addressed in the comprehensive PACES-CIED document [3], with further data easily accessible in electronic searches or textbooks.

2021 PACES expert consensus statement on the indications and management of cardiovascular implantable electronic devices in pediatric patients.

In view of the increasing complexity of both cardiovascular implantable electronic devices (CIEDs) and patients in the current era, practice guidelines, by necessity, have become increasingly specific. This document is an expert consensus statement that has been developed to update and further delineate indications and management of CIEDs in pediatric patients, defined as ≤21 years of age, and is intended to focus primarily on the indications for CIEDs in the setting of specific disease categories. The document also highlights variations between previously published adult and pediatric CIED recommendations and provides rationale for underlying important differences. The document addresses some of the deterrents to CIED access in low- and middle-income countries and strategies to circumvent them. The document sections were divided up and drafted by the writing committee members according to their expertise. The recommendations represent the consensus opinion of the entire writing committee, graded by class of recommendation and level of evidence. Several questions addressed in this document either do not lend themselves to clinical trials or are rare disease entities, and in these instances recommendations are based on consensus expert opinion. Furthermore, specific recommendations, even when supported by substantial data, do not replace the need for clinical judgment and patient-specific decision-making. The recommendations were opened for public comment to Pediatric and Congenital Electrophysiology Society (PACES) members and underwent external review by the scientific and clinical document committee of the Heart Rhythm Society (HRS), the science advisory and coordinating committee of the American Heart Association (AHA), the American College of Cardiology (ACC), and the Association for European Paediatric and Congenital Cardiology (AEPC). The document received endorsement by all the collaborators and the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS). This document is expected to provide support for clinicians and patients to allow for appropriate CIED use, appropriate CIED management, and appropriate CIED follow-up in pediatric patients.