Voice-assisted Artificial Intelligence-enabled Screening for Severe Acute Respiratory Syndrome Coronavirus 2 Exposure in Cardiovascular Clinics: Primary Results of the VOICE-COVID-19-II Randomized Trial.

BACKGROUND: Voice-assisted artificial intelligence-based systems may streamline clinical care among patients with heart failure (HF) and caregivers; however, randomized clinical trials are needed. We evaluated the potential for Amazon Alexa (Alexa), a voice-assisted artificial intelligence-based system, to conduct screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a HF clinic. METHODS AND RESULTS: We enrolled 52 participants (patients and caregivers) from a HF clinic who were randomly assigned with a subsequent cross-over to receive a SARS-CoV-2 screening questionnaire via Alexa or health care personnel. The primary outcome was overall response concordance, as measured by the percentage of agreement and unweighted kappa scores between groups. A postscreening survey evaluated comfort with using the artificial intelligence-based device. In total, 36 participants (69%) were male, the median age was 51 years (range 34-65 years) years and 36 (69%) were English speaking. Twenty-one participants (40%) were patients with HF. For the primary outcome, there were no statistical differences between the groups: Alexa-research coordinator group 96.9% agreement and unweighted kappa score of 0.92 (95% confidence interval 0.84-1.00) vs research coordinator-Alexa group 98.5% agreement and unweighted kappa score of 0.95 (95% confidence interval 0.88-1.00) (P value for all comparisons > .05). Overall, 87% of participants rated their screening experience as good or outstanding. CONCLUSIONS: Alexa demonstrated comparable performance to a health care professional for SARS-CoV-2 screening in a group of patients with HF and caregivers and may represent an attractive approach to symptom screening in this population. Future studies evaluating such technologies for other uses among patients with HF and caregivers are warranted. NCT04508972.

Digital Tool-Assisted Hospitalization Detection in the Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention Study Compared to Traditional Site-Coordinator Ascertainment: Intervention Study.

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.

Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry.

BACKGROUND: Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) is the largest cardiovascular genotype-based randomized pragmatic trial (NCT#01742117) to evaluate the role of genotype-guided selection of oral P2Y12 inhibitor therapy in improving ischemic outcomes after PCI. The trial has been extended from the original 12- to 24-month follow-up, using study coordinator-initiated telephone visits. TAILOR-PCI Digital Study tests the feasibility of extending the trial follow-up in a subset of patients for up to 24 months using state-of-the-art digital solutions. The rationale, design, and approach of extended digital study of patients recruited into a large, international, multi-center clinical trial has not been previously described. METHODS: A total of 930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls. Eureka, a direct-to-participant digital research platform, is used to consent and collect prospective data on patients for the digital study. Patients are asked to answer health-related surveys at fixed intervals using the Eureka mobile app and or desktop platform. The likelihood of patients enrolled in a randomized clinical trial transitioning to a registry using digital technology, the reasons for nonparticipation and engagement rates are evaluated. To capture hospitalizations, patients may optionally enable geofencing, a process that allows background location tracking and triggering of surveys if a hospital visit greater than 4 hours is detected. In addition, patients answer digital hospitalization surveys every month. Hospitalization data received from the Digital Study will be compared to data collected from study coordinator telephone visits during the same time frame. CONCLUSIONS: The TAILOR-PCI Digital Study evaluates the feasibility of transitioning a large multicenter randomized clinical trial to a digital registry. The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials. Such a digital approach may be especially pertinent in the era of COVID-19.

EventDTW: An Improved Dynamic Time Warping Algorithm for Aligning Biomedical Signals of Nonuniform Sampling Frequencies.

The dynamic time warping (DTW) algorithm is widely used in pattern matching and sequence alignment tasks, including speech recognition and time series clustering. However, DTW algorithms perform poorly when aligning sequences of uneven sampling frequencies. This makes it difficult to apply DTW to practical problems, such as aligning signals that are recorded simultaneously by sensors with different, uneven, and dynamic sampling frequencies. As multi-modal sensing technologies become increasingly popular, it is necessary to develop methods for high quality alignment of such signals. Here we propose a DTW algorithm called EventDTW which uses information propagated from defined events as basis for path matching and hence sequence alignment. We have developed two metrics, the error rate (ER) and the singularity score (SS), to define and evaluate alignment quality and to enable comparison of performance across DTW algorithms. We demonstrate the utility of these metrics on 84 publicly-available signals in addition to our own multi-modal biomedical signals. EventDTW outperformed existing DTW algorithms for optimal alignment of signals with different sampling frequencies in 37% of artificial signal alignment tasks and 76% of real-world signal alignment tasks.

Everolimus-eluting bioresorbable vascular scaffold implantation to treat saphenous vein graft disease, single-center initial experience.

AIMS: Recent studies have shown favorable outcomes with everolimus-eluting bioresorbable vascular scaffold (BVS) in patients with stable coronary artery disease. Data on the use of BVS in saphenous vein graft disease (SVG) is currently lacking. METHODS AND RESULTS: A total of 10 consecutive patients (13 lesions, including 6 in-stent restenosis) who underwent BVS for SVG disease between May 2013 and June 2015 at a tertiary care institution were included. Median follow-up period was 874 (720-926) days. One patient had scaffold thrombosis (ScT) 15 months after implantation, which was treated medically. Another patient had target lesion revascularization (TLR) in two different lesions, where BVS was used to treat in-stent restenosis. The composite endpoint of TLR, ScT, target vessel myocardial infarction, and cardiac death, was reached in two patients CONCLUSIONS: This first real-world data on the use of the ABSORB™ BVS in patients with SVG disease shows that its implantation is technically feasible. The observed rate of target lesion revascularization was similar to those observed with drug-eluting stents in similar settings. Larger studies are required to better define the optimal use of BVS to treat SVG disease.

Bioresorbable vascular scaffold to treat in-stent restenosis: Single-center experience.

AIMS: The management of patients with in-stent restenosis (ISR) is still a major clinical challenge even in the era of drug-eluting stents (DES). Recent studies have demonstrated acceptable clinical outcomes for the everolimus-eluting bioresorbable vascular scaffold (BVS) ABSORB™ in patients with stable coronary artery disease but data are scarce on its use in patients with ISR. We report the long-term results of our preliminary experience with this novel approach at our institution. METHODS AND RESULTS: We investigated the safety and efficacy of BVS implantation to treat ISR. 34 consecutive patients (37 lesions) underwent PCI for ISR with BVS implantation between May 2013 and June 2015 at our institution and were included in the current analysis. Follow-up was available in 91.9% of the patients. Mean follow-up period was 801.9 ± 179 days. One patient had definite scaffold thrombosis (ScT) 2 months after stent implantation which was treated with DES. Five patients (six lesions) experienced target lesion revascularization (TLR). The composite endpoint rate of TLR, ScT, myocardial infarction, and death occured in 6/37 lesions at follow-up (16.2%). CONCLUSIONS: These real-world data using BVS in patients with ISR demonstrates that ISR treatment with ABSORB™ BVS is feasible but could have slightly higher target lesion failure rates as compared to DES. This proof of concept could be hypothesis-generating for larger randomized controlled studies.

Advancing Fairness in Cardiac Care: Strategies for Mitigating Bias in Artificial Intelligence Models Within Cardiology.

In the dynamic field of medical artificial intelligence (AI), cardiology stands out as a key area for its technological advancements and clinical application. In this review we explore the complex issue of data bias, specifically addressing those encountered during the development and implementation of AI tools in cardiology. We dissect the origins and effects of these biases, which challenge their reliability and widespread applicability in health care. Using a case study, we highlight the complexities involved in addressing these biases from a clinical viewpoint. The goal of this review is to equip researchers and clinicians with the practical knowledge needed to identify, understand, and mitigate these biases, advocating for the creation of AI solutions that are not just technologically sound, but also fair and effective for all patients.

Applying Artificial Intelligence for Phenotyping of Inherited Arrhythmia Syndromes.

Inherited arrhythmia disorders account for a significant proportion of sudden cardiac death, particularly among young individuals. Recent advances in our understanding of these syndromes have improved patient diagnosis and care, yet certain clinical gaps remain, particularly within case ascertainment, access to genetic testing, and risk stratification. Artificial intelligence (AI), specifically machine learning and its subset deep learning, present promising solutions to these challenges. The capacity of AI to process vast amounts of patient data and identify disease patterns differentiates them from traditional methods, which are time- and resource-intensive. To date, AI models have shown immense potential in condition detection (including asymptomatic/concealed disease) and genotype and phenotype identification, exceeding expert cardiologists in these tasks. Additionally, they have exhibited applicability for general population screening, improving case ascertainment in a set of conditions that are often asymptomatic such as left ventricular dysfunction. Third, models have shown the ability to improve testing protocols; through model identification of disease and genotype, specific clinical testing (eg, drug challenges or further diagnostic imaging) can be avoided, reducing health care expenses, speeding diagnosis, and possibly allowing for more incremental or targeted genetic testing approaches. These significant benefits warrant continued investigation of AI, particularly regarding the development and implementation of clinically applicable screening tools. In this review we summarize key developments in AI, including studies in long QT syndrome, Brugada syndrome, hypertrophic cardiomyopathy, and arrhythmogenic cardiomyopathies, and provide direction for effective future AI implementation in clinical practice.

Impact of age and comorbid heart failure on the utility of smart voice-assistant devices.

Aims: The accuracy of voice-assisted technologies, such as Amazon Alexa, to collect data in patients who are older or have heart failure (HF) is unknown. The aim of this study is to analyse the impact of increasing age and comorbid HF, when compared with younger participants and caregivers, and how these different subgroups classify their experience using a voice-assistant device, for screening purposes. Methods and results: Subgroup analysis (HF vs. caregivers and younger vs. older participants) of the VOICE-COVID-II trial, a randomized controlled study where participants were assigned with subsequent crossover to receive a SARS-CoV2 screening questionnaire by Amazon Alexa or a healthcare personnel. Overall concordance between the two methods was compared using unweighted kappa scores and percentage of agreement. From the 52 participants included, the median age was 51 (34-65) years and 21 (40%) were HF patients. The HF subgroup showed a significantly lower percentage of agreement compared with caregivers (95% vs. 99%, P = 0.03), and both the HF and older subgroups tended to have lower unweighted kappa scores than their counterparts. In a post-screening survey, both the HF and older subgroups were less acquainted and found the voice-assistant device more difficult to use compared with caregivers and younger individuals. Conclusion: This subgroup analysis highlights important differences in the performance of a voice-assistant-based technology in an older and comorbid HF population. Younger individuals and caregivers, serving as facilitators, have the potential to bridge the gap and enhance the integration of these technologies into clinical practice. Study Registration: ClinicalTrials.gov Identifier: NCT04508972.

Continuous Atrial Fibrillation Monitoring From Photoplethysmography: Comparison Between Supervised Deep Learning and Heuristic Signal Processing.

BACKGROUND: Continuous monitoring for atrial fibrillation (AF) using photoplethysmography (PPG) from smartwatches or other wearables is challenging due to periods of poor signal quality during motion or suboptimal wearing. As a result, many consumer wearables sample infrequently and only analyze when the user is at rest, which limits the ability to perform continuous monitoring or to quantify AF. OBJECTIVES: This study aimed to compare 2 methods of continuous monitoring for AF in free-living patients: a well-validated signal processing (SP) heuristic and a convolutional deep neural network (DNN) trained on raw signal. METHODS: We collected 4 weeks of continuous PPG and electrocardiography signals in 204 free-living patients. Both SP and DNN models were developed and validated both on holdout patients and an external validation set. RESULTS: The results show that the SP model demonstrated receiver-operating characteristic area under the curve (AUC) of 0.972 (sensitivity 99.6%, specificity: 94.4%), which was similar to the DNN receiver-operating characteristic AUC of 0.973 (sensitivity 92.2, specificity: 95.5%); however, the DNN classified significantly more data (95% vs 62%), revealing its superior tolerance of tracings prone to motion artifact. Explainability analysis revealed that the DNN automatically suppresses motion artifacts, evaluates irregularity, and learns natural AF interbeat variability. The DNN performed better and analyzed more signal in the external validation cohort using a different population and PPG sensor (AUC, 0.994; 97% analyzed vs AUC, 0.989; 88% analyzed). CONCLUSIONS: DNNs perform at least as well as SP models, classify more data, and thus may be better for continuous PPG monitoring.

Revolutionizing Acute Cardiac Care with Artificial Intelligence: Opportunities and Challenges.

This manuscript reviews the application of artificial intelligence (AI) in acute cardiac care, highlighting its potential to transform patient outcomes in the face of the global burden of cardiovascular diseases. It explores how AI algorithms can rapidly and accurately process data for the prediction and diagnosis of acute cardiac conditions. The paper examines AI's impact on patient health across various diagnostic tools such as echocardiography, electrocardiography, coronary angiography, cardiac CT, and MRI and discusses the regulatory landscape for AI in healthcare, categorizes AI algorithms by their risk levels. Furthermore, it addresses the challenges of data quality, generalizability, bias, transparency, and regulatory considerations, underscoring the necessity for inclusive data and robust validation processes. The review concludes with future perspectives on integrating AI into clinical workflows and the ongoing need for research, regulation, and innovation to harness AI's full potential in improving acute cardiac care.

Maximising Large Language Model Utility in Cardiovascular Care: A Practical Guide.

Large language models (LLMs) have emerged as powerful tools in artificial intelligence, demonstrating remarkable capabilities in natural language processing and generation. In this article, we explore the potential applications of LLMs in enhancing cardiovascular care and research. We discuss how LLMs can be used to simplify complex medical information, improve patient-physician communication, and automate tasks such as summarising medical articles and extracting key information. In addition, we highlight the role of LLMs in categorising and analysing unstructured data, such as medical notes and test results, which could revolutionise data handling and interpretation in cardiovascular research. However, we also emphasise the limitations and challenges associated with LLMs, including potential biases, reasoning opacity, and the need for rigourous validation in medical contexts. This review provides a practical guide for cardiovascular professionals to understand and harness the power of LLMs while navigating their limitations. We conclude by discussing the future directions and implications of LLMs in transforming cardiovascular care and research.

A responsible framework for applying artificial intelligence on medical images and signals at the point-of-care: the PACS-AI platform.

The potential of artificial intelligence (AI) in medicine lies in its ability to enhance clinicians' capacity to analyze medical images, thereby improving diagnostic precision and accuracy, thus enhancing current tests. However, the integration of AI within healthcare is fraught with difficulties. Heterogeneity among healthcare system applications, reliance on proprietary closed-source software, and rising cyber-security threats pose significant challenges. Moreover, prior to their deployment in clinical settings, AI models must demonstrate their effectiveness across a wide range of scenarios and must be validated by prospective studies, but doing so requires testing in an environment mirroring the clinical workflow which is difficult to achieve without dedicated software. Finally, the use of AI techniques in healthcare raises significant legal and ethical issues, such as the protection of patient privacy, the prevention of bias, and the monitoring of the device's safety and effectiveness for regulatory compliance. This review describes challenges to AI integration in healthcare and provides guidelines on how to move forward. We describe an open-source solution that we developed which integrates AI models into the Picture Archives Communication System (PACS), called PACS-AI. This approach aims to increase the evaluation of AI models by facilitating their integration and validation with existing medical imaging databases. PACS-AI may overcome many current barriers to AI deployment and offers a pathway towards responsible, fair, and effective deployment of AI models in healthcare. Additionally, we propose a list of criteria and guidelines that AI researchers should adopt when publishing a medical AI model, to enhance standardization and reproducibility.

Evaluation of stenoses using AI video models applied to coronary angiography.

The coronary angiogram is the gold standard for evaluating the severity of coronary artery disease stenoses. Presently, the assessment is conducted visually by cardiologists, a method that lacks standardization. This study introduces DeepCoro, a ground-breaking AI-driven pipeline that integrates advanced vessel tracking and a video-based Swin3D model that was trained and validated on a dataset comprised of 182,418 coronary angiography videos spanning 5 years. DeepCoro achieved a notable precision of 71.89% in identifying coronary artery segments and demonstrated a mean absolute error of 20.15% (95% CI: 19.88-20.40) and a classification AUROC of 0.8294 (95% CI: 0.8215-0.8373) in stenosis percentage prediction compared to traditional cardiologist assessments. When compared to two expert interventional cardiologists, DeepCoro achieved lower variability than the clinical reports (19.09%; 95% CI: 18.55-19.58 vs 21.00%; 95% CI: 20.20-21.76, respectively). In addition, DeepCoro can be fine-tuned to a different modality type. When fine-tuned on quantitative coronary angiography assessments, DeepCoro attained an even lower mean absolute error of 7.75% (95% CI: 7.37-8.07), underscoring the reduced variability inherent to this method. This study establishes DeepCoro as an innovative video-based, adaptable tool in coronary artery disease analysis, significantly enhancing the precision and reliability of stenosis assessment.

Deep Learning-Augmented ECG Analysis for Screening and Genotype Prediction of Congenital Long QT Syndrome.

Importance: Congenital long QT syndrome (LQTS) is associated with syncope, ventricular arrhythmias, and sudden death. Half of patients with LQTS have a normal or borderline-normal QT interval despite LQTS often being detected by QT prolongation on resting electrocardiography (ECG). Objective: To develop a deep learning-based neural network for identification of LQTS and differentiation of genotypes (LQTS1 and LQTS2) using 12-lead ECG. Design, Setting, and Participants: This diagnostic accuracy study used ECGs from patients with suspected inherited arrhythmia enrolled in the Hearts in Rhythm Organization Registry (HiRO) from August 2012 to December 2021. The internal dataset was derived at 2 sites and an external validation dataset at 4 sites within the HiRO Registry; an additional cross-sectional validation dataset was from the Montreal Heart Institute. The cohort with LQTS included probands and relatives with pathogenic or likely pathogenic variants in KCNQ1 or KCNH2 genes with normal or prolonged corrected QT (QTc) intervals. Exposures: Convolutional neural network (CNN) discrimination between LQTS1, LQTS2, and negative genetic test results. Main Outcomes and Measures: The main outcomes were area under the curve (AUC), F1 scores, and sensitivity for detecting LQTS and differentiating genotypes using a CNN method compared with QTc-based detection. Results: A total of 4521 ECGs from 990 patients (mean [SD] age, 42 [18] years; 589 [59.5%] female) were analyzed. External validation within the national registry (101 patients) demonstrated the CNN's high diagnostic capacity for LQTS detection (AUC, 0.93; 95% CI, 0.89-0.96) and genotype differentiation (AUC, 0.91; 95% CI, 0.86-0.96). This surpassed expert-measured QTc intervals in detecting LQTS (F1 score, 0.84 [95% CI, 0.78-0.90] vs 0.22 [95% CI, 0.13-0.31]; sensitivity, 0.90 [95% CI, 0.86-0.94] vs 0.36 [95% CI, 0.23-0.47]), including in patients with normal or borderline QTc intervals (F1 score, 0.70 [95% CI, 0.40-1.00]; sensitivity, 0.78 [95% CI, 0.53-0.95]). In further validation in a cross-sectional cohort (406 patients) of high-risk patients and genotype-negative controls, the CNN detected LQTS with an AUC of 0.81 (95% CI, 0.80-0.85), which was better than QTc interval-based detection (AUC, 0.74; 95% CI, 0.69-0.78). Conclusions and Relevance: The deep learning model improved detection of congenital LQTS from resting ECGs and allowed for differentiation between the 2 most common genetic subtypes. Broader validation over an unselected general population may support application of this model to patients with suspected LQTS.