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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
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
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
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
Coronary Atheroma Regression and Plaque Characteristics Assessed by Grayscale and Radiofrequency Intravascular Ultrasound After Aerobic Exercise
The aim of the present study was to investigate effects of aerobic interval training (AIT) versus moderate continuous training (MCT) on coronary atherosclerosis in patients with significant coronary artery disease on optimal medical treatment. Thirty-six patients were randomized to AIT (intervals at ≈ 90% of peak heart rate) or MCT (continuous exercise at ≈ 70% of peak heart rate) 3 times a week for 12 weeks after intracoronary stent implantation. Grayscale and radiofrequency intravascular ultrasounds (IVUS) were performed at baseline and follow-up. The primary end point was the change in plaque burden, and the secondary end points were change in necrotic core and plaque vulnerability. Separate lesions were classified using radiofrequency IVUS criteria. We demonstrated that necrotic core was reduced in both groups in defined coronary segments (AIT −3.2%, MCT −2.7%, p <0.05) and in separate lesions (median change −2.3% and −0.15 mm3, p <0.05). Plaque burden was reduced by 10.7% in separate lesions independent of intervention group (p = 0.06). No significant differences in IVUS parameters were found between exercise groups. A minority of separate lesions were transformed in terms of plaque vulnerability during follow-up with large individual differences between and within patients. In conclusion, changes in coronary artery plaque structure or morphology did not differ between patients who underwent AIT or MCT. The combination of regular aerobic exercise and optimal medical treatment for 12 weeks induced a moderate regression of necrotic core and plaque burden in IVUS-defined coronary lesions.
Journal Article
The Effect of Strict Volume Control Assessed by Repeated Bioimpedance Spectroscopy on Cardiac Function in Peritoneal Dialysis Patients
Adequate fluid management plays an important role in decreasing cardiovascular risk in peritoneal dialysis (PD) patients. We evaluated whether strict volume control monitored by bioimpedance spectroscopy (BIS) affects cardiac function in PD patients. This study is a secondary analysis of a multicentre, prospective, randomized, controlled trial. Fluid overload was assessed by the average overhydration/extracellular water (OH/ECW) at baseline, 6 months and 12 months. Patients were categorized as time-averaged overhydrated (TA-OH/ECW ≥15%) or normohydrated (TA-OH/ECW <15%), and echocardiographic parameters were compared between groups. Among a total of 151 patients, 120 patients exhibited time-averaged normohydration. Time-averaged overhydrated patients had a significantly higher left atrial (LA) diameter and E/e′ ratio and a lower left ventricular (LV) ejection fraction at 12 months than time-averaged normohydrated patients. LA diameter, end-systolic volume and end-diastolic volume were decreased at 12 months compared to baseline in time-averaged normohydrated patients only. TA-OH/ECW was independently associated with ejection fraction at 12 months (β = −0.190; p = 0.010). TA-OH/ECW, but not OH/ECW at 12 months, was an independent risk factor for LV dysfunction (odds ratio 4.020 [95% confidence interval 1.285–12.573]). Overhydration status based on repeated BIS measurements is an independent predictor of LV systolic function in PD patients.
Journal Article
Diagnostic and prognostic role of nitroglycerin-induced dilation in patients with suspected vasospastic angina, combined with ergonovine provocation test
The diagnostic and prognostic role of nitroglycerin-induced dilation (NID) combined with ergonovine provocation test in patients with suspected VSA patients is not clear. A total of 438 consecutive patients who underwent the ergonovine provocation test for the diagnosis of vasospastic angina (VSA) were enrolled. Patients with VSA (n = 52) had a significantly greater coronary response to ergonovine (− 84.3 ± 10.5% vs. − 38.4 ± 17.9%,
p
< 0.001) and NID (26.3 ± 31.0% vs. 12.5 ± 19.0%,
p
< 0.001) than non-VSA patients. However, positive NID (more than 13.8% dilation, n = 170) showed a poor accuracy (AUC 0.64 [95% CI: 0.56–0.73],
p
= 0.001, sensitivity 60.4%, specificity 61.3%) for the diagnosis of VSA by ergonovine provocation test. Major adverse cardiovascular events (MACE) occurred more frequently in the VSA group than in the non-VSA group (9.6% vs. 2.2%,
p
= 0.006). In addition, the positive NID group showed a lower rate of MACE than the negative NID group (1.2% vs. 4.3%,
p
= 0.021). Interestingly, the group of VSA with negative NID had poor prognosis than any other combinations (Log-rank,
p
< 0.0001). Although NID had a limited role in the detection of VSA defined by ergonovine provocation test, NID combined with the ergonovine provocation test has an additive prognostic role in the clinical outcomes in patients with suspected VSA.
Journal Article
The effect of supplemental oxygen on perioperative brain natriuretic peptide concentration in cardiac risk patients – a protocol for a prosprective randomized clinical trial
Background
Elevated postoperative
N
-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations are predictive for cardiac adverse events in noncardiac surgery. Studies indicate that supplemental oxygen decreases sympathetic nerve activity and might, therefore, improve cardiovascular function. Thus, we will test the effect of perioperative supplemental oxygen administration on NT-proBNP release after surgery.
Methods/design
We will conduct a single-center, double-blinded, randomized trial at the Medical University of Vienna, including 260 patients with increased cardiac risk factors undergoing moderate- to high-risk noncardiac surgery. Patients will be randomly assigned to receive 80% versus 30% oxygen during surgery and for 2 h postoperatively. The primary outcome will be the difference in maximum NT-proBNP release after surgery.
As secondary outcomes we will assess the effect of supplemental oxygen on postoperative maximum troponin T concentration, oxidation-reduction potential, von Willebrand factor concentration and perioperative fluid requirements. We will perform outcome measurements 2 h after surgery, on postoperative day 1 and on postoperative day 3. The NT-proBNP concentration and the oxidation-reduction potential will also be measured within 72 h before discharge.
Discussion
Our trial should determine whether perioperative supplemental oxygen administration will reduce the postoperative release of NT-proBNP in patients with preoperative increased cardiovascular risk factors undergoing noncardiac surgery.
Trial registration
ClinicalTrials.gov, ID:
NCT03366857
. Registered on 8th December 2017.
Journal Article