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Blinded, randomized trial of sonographer versus AI cardiac function assessment
Artificial intelligence (AI) has been developed for echocardiography
1
–
3
, although it has not yet been tested with blinding and randomization. Here we designed a blinded, randomized non-inferiority clinical trial (ClinicalTrials.gov ID: NCT05140642; no outside funding) of AI versus sonographer initial assessment of left ventricular ejection fraction (LVEF) to evaluate the impact of AI in the interpretation workflow. The primary end point was the change in the LVEF between initial AI or sonographer assessment and final cardiologist assessment, evaluated by the proportion of studies with substantial change (more than 5% change). From 3,769 echocardiographic studies screened, 274 studies were excluded owing to poor image quality. The proportion of studies substantially changed was 16.8% in the AI group and 27.2% in the sonographer group (difference of −10.4%, 95% confidence interval: −13.2% to −7.7%,
P
< 0.001 for non-inferiority,
P
< 0.001 for superiority). The mean absolute difference between final cardiologist assessment and independent previous cardiologist assessment was 6.29% in the AI group and 7.23% in the sonographer group (difference of −0.96%, 95% confidence interval: −1.34% to −0.54%,
P
< 0.001 for superiority). The AI-guided workflow saved time for both sonographers and cardiologists, and cardiologists were not able to distinguish between the initial assessments by AI versus the sonographer (blinding index of 0.088). For patients undergoing echocardiographic quantification of cardiac function, initial assessment of LVEF by AI was non-inferior to assessment by sonographers.
The impact of artificial intelligence in cardiac function assessment is evaluated by a blinded, randomized non-inferiority trial of artificial intelligence versus sonographer initial assessment of the left ventricular ejection fraction.
Journal Article
Artificial intelligence–enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial
We have conducted a pragmatic clinical trial aimed to assess whether an electrocardiogram (ECG)-based, artificial intelligence (AI)-powered clinical decision support tool enables early diagnosis of low ejection fraction (EF), a condition that is underdiagnosed but treatable. In this trial (
NCT04000087
), 120 primary care teams from 45 clinics or hospitals were cluster-randomized to either the intervention arm (access to AI results; 181 clinicians) or the control arm (usual care; 177 clinicians). ECGs were obtained as part of routine care from a total of 22,641 adults (
N
= 11,573 intervention;
N
= 11,068 control) without prior heart failure. The primary outcome was a new diagnosis of low EF (≤50%) within 90 days of the ECG. The trial met the prespecified primary endpoint, demonstrating that the intervention increased the diagnosis of low EF in the overall cohort (1.6% in the control arm versus 2.1% in the intervention arm, odds ratio (OR) 1.32 (1.01–1.61),
P
= 0.007) and among those who were identified as having a high likelihood of low EF (that is, positive AI-ECG, 6% of the overall cohort) (14.5% in the control arm versus 19.5% in the intervention arm, OR 1.43 (1.08–1.91),
P
= 0.01). In the overall cohort, echocardiogram utilization was similar between the two arms (18.2% control versus 19.2% intervention,
P
= 0.17); for patients with positive AI-ECGs, more echocardiograms were obtained in the intervention compared to the control arm (38.1% control versus 49.6% intervention,
P
< 0.001). These results indicate that use of an AI algorithm based on ECGs can enable the early diagnosis of low EF in patients in the setting of routine primary care.
In a pragmatic, cluster-randomized clinical trial, use of an AI algorithm for interpretation of electrocardiograms in primary care practices increased the frequency at which impaired heart function was diagnosed.
Journal Article
The mechanosensitive Piezo1 channel mediates heart mechano-chemo transduction
The beating heart possesses the intrinsic ability to adapt cardiac output to changes in mechanical load. The century-old Frank–Starling law and Anrep effect have documented that stretching the heart during diastolic filling increases its contractile force. However, the molecular mechanotransduction mechanism and its impact on cardiac health and disease remain elusive. Here we show that the mechanically activated Piezo1 channel converts mechanical stretch of cardiomyocytes into Ca
2+
and reactive oxygen species (ROS) signaling, which critically determines the mechanical activity of the heart. Either cardiac-specific knockout or overexpression of Piezo1 in mice results in defective Ca
2+
and ROS signaling and the development of cardiomyopathy, demonstrating a homeostatic role of Piezo1. Piezo1 is pathologically upregulated in both mouse and human diseased hearts via an autonomic response of cardiomyocytes. Thus, Piezo1 serves as a key cardiac mechanotransducer for initiating mechano-chemo transduction and consequently maintaining normal heart function, and might represent a novel therapeutic target for treating human heart diseases.
The beating heart adapts cardiac output to changes in mechanical load via incompletely understood mechanotransduction mechanisms. Here the authors show that the mechanosensitive Piezo1 channel serves as a mechanotransducer for directly converting mechanical stretch of cardiomyocytes into Ca
2+
and ROS signaling and consequently maintaining normal heart function.
Journal Article
Tracking changes in cardiac output: methodological considerations for the validation of monitoring devices
Background
Until now, tools for continuous cardiac output (CO) monitoring have been validated as if they were tools for snapshot measurements. Most authors have compared variations in cardiac output between two time-points and used Bland–Altman representations to describe the agreement between these variations. The impacts of time and of repetitive measurements over time are not taken into consideration.
Purpose
This special article proposes a conceptual framework for the validation of CO monitoring devices. Four quality criteria are suggested and studied: (1) accuracy (small bias), (2) precision (small random error of measurements), (3) short response time and (4) accurate amplitude response. Because a tolerance is obviously admitted for each of these four criteria, we propose to add as a fifth criterion the ability to detect significant CO directional changes. Other important issues in designing studies to validate CO monitoring tools are reviewed: choice of patient population to be studied, choice of the reference method, data acquisition method, data acceptability checking, data segmentation and final evaluation of reliability.
Conclusion
Application of this framework underlines the importance of precision and time response for clinical acceptability of monitoring tools.
Journal Article
Pearls and pitfalls in comprehensive critical care echocardiography
Critical care echocardiography is developing rapidly with an increasing number of specialists now performing comprehensive studies using Doppler and other advanced techniques. However, this imaging can be challenging, interpretation is far from simple in the complex critically ill patient and mistakes can be easy to make. We aim to address clinically relevant areas where potential errors may occur and suggest methods to hopefully improve accuracy of imaging and interpretation.
Journal Article
Cardiac manifestations of COVID-19 in Shenzhen, China
PurposeThe coronavirus disease 2019 (COVID-19) outbreak has become a global public health concern; however, relatively few detailed reports of related cardiac injury are available. The aims of this study were to compare the clinical and echocardiographic characteristics of inpatients in the intensive-care unit (ICU) and non-ICU patients.MethodsWe recruited 416 patients diagnosed with COVID-19 and divided them into two groups: ICU (n = 35) and non-ICU (n = 381). Medical histories, laboratory findings, and echocardiography data were compared.ResultsThe levels of myocardial injury markers in ICU vs non-ICU patients were as follows: troponin I (0.029 ng/mL [0.007–0.063] vs 0.006 ng/mL [0.006–0.006]) and myoglobin (65.45 μg/L [39.77–130.57] vs 37.00 μg/L [26.40–53.54]). Echocardiographic findings included ventricular wall thickening (12 [39%] vs 1 [4%]), pulmonary hypertension (9 [29%] vs 0 [0%]), and reduced left-ventricular ejection fraction (5 [16%] vs 0 [0%]). Overall, 10% of the ICU patients presented with right heart enlargement, thickened right-ventricular wall, decreased right heart function, and pericardial effusion. Cardiac complications were more common in ICU patients, including acute cardiac injury (21 [60%] vs 13 [3%]) (including 2 cases of fulminant myocarditis), atrial or ventricular tachyarrhythmia (3 [9%] vs 3 [1%]), and acute heart failure (5 [14%] vs 0 [0%]).ConclusionMyocardial injury marker elevation, ventricular wall thickening, pulmonary artery hypertension, and cardiac complications including acute myocardial injury, arrhythmia, and acute heart failure are more common in ICU patients with COVID-19. Cardiac injury in COVID-19 patients may be related more to the systemic response after infection rather than direct damage by coronavirus.
Journal Article
Antisense Therapy Attenuates Phospholamban p.(Arg14del) Cardiomyopathy in Mice and Reverses Protein Aggregation
Inherited cardiomyopathy caused by the p.(Arg14del) pathogenic variant of the phospholamban (PLN) gene is characterized by intracardiomyocyte PLN aggregation and can lead to severe dilated cardiomyopathy. We recently reported that pre-emptive depletion of PLN attenuated heart failure (HF) in several cardiomyopathy models. Here, we investigated if administration of a Pln-targeting antisense oligonucleotide (ASO) could halt or reverse disease progression in mice with advanced PLN-R14del cardiomyopathy. To this aim, homozygous PLN-R14del (PLN-R14 Δ/Δ) mice received PLN-ASO injections starting at 5 or 6 weeks of age, in the presence of moderate or severe HF, respectively. Mice were monitored for another 4 months with echocardiographic analyses at several timepoints, after which cardiac tissues were examined for pathological remodeling. We found that vehicle-treated PLN-R14 Δ/Δ mice continued to develop severe HF, and reached a humane endpoint at 8.1 ± 0.5 weeks of age. Both early and late PLN-ASO administration halted further cardiac remodeling and dysfunction shortly after treatment start, resulting in a life span extension to at least 22 weeks of age. Earlier treatment initiation halted disease development sooner, resulting in better heart function and less remodeling at the study endpoint. PLN-ASO treatment almost completely eliminated PLN aggregates, and normalized levels of autophagic proteins. In conclusion, these findings indicate that PLN-ASO therapy may have beneficial outcomes in PLN-R14del cardiomyopathy when administered after disease onset. Although existing tissue damage was not reversed, further cardiomyopathy progression was stopped, and PLN aggregates were resolved.
Journal Article
Comparison of echocardiographic indices of right ventricular systolic function and ejection fraction obtained with continuous thermodilution in critically ill patients
Background
Though echocardiographic evaluation assesses the right ventricular systolic function, which of the existing parameters best reflects the right ventricular ejection fraction (RVEF) in the critically ill patients is still uncertain. We aimed to determine the relationship between echocardiographic indices of right ventricular systolic function and RVEF.
Methods
Prospective observational study was conducted in a mixed Surgical Intensive Care Unit (Hôpital Lariboisière, Paris, France) from November 2017 to November 2018. All critically ill patients monitored with a pulmonary artery catheter were assessed. We collected echocardiographic indices of right ventricular function (tricuspid annular plane systolic excursion, TAPSE; peak systolic velocity of pulsed tissue Doppler at lateral tricuspid annulus, S′; fractional area change, FAC; right ventricular index of myocardial performance, RIMP; isovolumic acceleration, IVA; end-diastolic diameter ratio, EDDr) and compared them with the RVEF obtained from continuous volumetric pulmonary artery catheter.
Results
Twenty-five patients were analyzed. Admission diagnosis was acute heart failure in 11 patients and septic shock in 14 patients. Median age was 70 years [57–80], norepinephrine median dose was 0.29 μg/kg/min [0.14–0.50], median Sequential Organ Failure Assessment score was 12 [10–14], and mortality at day 28 was 56%. When compared to RVEF, TAPSE had the highest correlation coefficient (rho = 0.78, 95% CI 0.52 to 0.89,
p
< 0.001). S′ was also correlated to RVEF (rho = 0.64, 95% CI 0.60 to 0.80,
p
= 0.001) whereas FAC, RIMP, IVA, and EDDr did not. TAPSE lower than 16 mm, S′ lower than 11 cm/s, and EDDr higher than 1 were always associated with a reduced RVEF.
Conclusions
We found that amongst indices of right ventricular systolic function, TAPSE and S′ were well correlated with thermodilution-derived RVEF in critically ill patients.
Journal Article
Return to play after COVID-19: a sport cardiologist’s view
In a series of 41 cases, 12% patients had elevated levels of troponin, indicating myocardial injury.2 Another study showed acute arrhythmias in 17% and acute myocardial injury in 7% of patients with COVID-19.3 In a meta-analysis including six studies with a total of 1527 patients with COVID-19, 8.0% suffered acute cardiac injury with an incidence about 13-fold higher in critically ill patients admitted in intensive care units.4 Increased levels of natriuretic peptides has also been reported in these patients and associated with worst prognostic.1 In some cases, cardiac involvement occurred even in patients without symptoms and signs of interstitial pneumonia, reinforcing the importance of subclinical cardiological investigation and measurement of cardiac biomarkers.5 Moreover, postmortem analysis suggests myocardial infiltration with mononuclear inflammatory cells. In order to identify a very low-risk group, who can be cleared without the need for supervised exercise testing, the evidence of recovery and risk stratification should be based in another information, such as: clear exclusion of symptoms suggestive of myocarditis or myopericarditis; deep knowledge of the infection “status” (repetition of viral tests when appropriate or immunological tests if available); exclusion of ongoing myocardial injury (normal troponin measurements); exclusion of significant arrhythmias (normal 24/48-hour Holter monitoring). After this period, it is reasonable to resume training and competition if left ventricular systolic function has returned to the normal range, serum biomarkers of myocardial injury have normalised and clinically significant arrhythmias such as frequent or complex repetitive forms of ventricular or supraventricular arrhythmias are absent on 24-hour Holter monitoring and exercise test.
Journal Article