Artificial Intelligence Applied to Electrical and Non-Invasive Hemodynamic Markers in Elderly Decompensated Chronic Heart Failure Patients.

OBJECTIVES: The first aim of this study was to assess the predictive power of Tend interval (Te) and non-invasive hemodynamic markers, based on bioimpedance in decompensated chronic heart failure (CHF). The second one was to verify the possible differences in repolarization and hemodynamic data between CHF patients grouped by level of left ventricular ejection fraction (LVEF). Finally, we wanted to check if repolarization and hemodynamic data changed with clinical improvement or worsening in CHF patients. METHODS: Two hundred and forty-three decompensated CHF patients were studied by 5 min ECG recordings to determine the mean and standard deviation (TeSD) of Te (first study). In a subgroup of 129 patients (second study), non-invasive hemodynamic and repolarization data were recorded for further evaluation. RESULTS: Total in-hospital and cardiovascular mortality rates were respectively 19 and 9%. Te was higher in the deceased than in surviving subjects (Te: 120 ± 28 vs. 100 ± 25 ms) and multivariable logistic regression analysis reported that Te was related to an increase of total (χ2: 35.45, odds ratio: 1.03, 95% confidence limit: 1.02-1.05, p < 0.001) and cardiovascular mortality (χ2: 32.58, odds ratio: 1.04, 95% confidence limit: 1.02-1.06, p < 0.001). Subjects with heart failure with reduced ejection fraction (HFrEF) reported higher levels of repolarization and lower non-invasive systolic hemodynamic data in comparison to those with preserved ejection fraction (HFpEF). In the subgroup, patients with the NT-proBNP reduction after therapy showed a lower rate of Te, heart rate, blood pressures, contractility index, and left ventricular ejection time in comparison with the patients without NT-proBNP reduction. CONCLUSION: Electrical signals from ECG and bioimpedance were capable of monitoring the patients with advanced decompensated CHF. These simple, inexpensive, non-invasive, easily repeatable, and transmissible markers could represent a tool to remotely monitor and to intercept the possible worsening of these patients early by machine learning and artificial intelligence tools.

Effect of Head-Up/-Down Tilt on ECG Segments and Myocardial Temporal Dispersion in Healthy Subjects.

The head-up/-down tilt test acutely modifies the autonomic nervous system balance throughout a deactivation of the cardiopulmonary reflexes. The present study examines the influence of head-up/-down tilt on a number of ECG segments. A total of 20 healthy subjects underwent a 5 min ECG and noninvasive hemodynamic bio-impedance recording, during free and controlled breathing, lying at (a) 0°; (b) -45°, tilting up at 45°, and tilting up at 90°. Heart rate variability power spectral analysis was obtained throughout some ECG intervals: P-P (P), P-Q (PQ), PeQ (from the end of P to Q wave), Q-R peak (QR intervals), Q-R-S (QRS), Q-T peak (QTp), Q-T end (QTe), STp, STe, T peak-T end (Te), and, eventually, the TeP segments (from the end of T to the next P waves). Results: In all study conditions, the Low Frequency/High FrequencyPP and LFPP normalized units (nu) were significantly lower than the LF/HFRR and LFRRnu, respectively. Conversely, the HFPP and HFPPnu were significantly higher in all study conditions. STe, QTp, and QTe were significantly related to the PP and RR intervals, whereas the T wave amplitude was inversely related to the standard deviations of all the myocardial repolarization variables and to the left ventricular end-systolic volume (LVEDV). The T wave amplitude diminished during head-up tilt and significantly correlated with the LVEDV.

A Machine Learning Approach for Predicting Capsular Contracture after Postmastectomy Radiotherapy in Breast Cancer Patients.

In recent years, immediate breast reconstruction after mastectomy surgery has steadily increased in the treatment pathway of breast cancer (BC) patients due to its potential impact on both the morpho-functional and aesthetic type of the breast and the quality of life. Although recent studies have demonstrated how recent radiotherapy techniques have allowed a reduction of adverse events related to breast reconstruction, capsular contracture (CC) remains the main complication after post-mastectomy radio-therapy (PMRT). In this study, we evaluated the association of the occurrence of CC with some clinical, histological and therapeutic parameters related to BC patients. We firstly performed bivariate statistical tests and we then evaluated the prognostic predictive power of the collected data by using machine learning techniques. Out of a sample of 59 patients referred to our institute, 28 patients (i.e., 47%) showed contracture after PMRT. As a result, only estrogen receptor status (ER) and molecular subtypes were significantly associated with the occurrence of CC after PMRT. Different machine learning models were trained on a subset of clinical features selected by a feature importance approach. Experimental results have shown that collected features have a non-negligible predictive power. The extreme gradient boosting classifier achieved an area under the curve (AUC) value of 68% and accuracy, sensitivity, and specificity values of 68%, 64%, and 74%, respectively. Such a support tool, after further suitable optimization and validation, would allow clinicians to identify the best therapeutic strategy and reconstructive timing.

Electrocardiographic and other Noninvasive Hemodynamic Markers in Decompensated CHF Patients.

Acutely decompensated chronic heart failure (adCHF) is among the most important causes of in-hospital mortality. R-wave peak time (RpT) or delayed intrinsicoid deflection was proposed as a risk marker of sudden cardiac death and heart failure decompensation. Authors want to verify if QR interval or RpT, obtained from 12-lead standard ECG and during 5-min ECG recordings (II lead), could be useful to identify adCHF. At hospital admission, patients underwent 5-min ECG recordings, obtaining mean and standard deviation (SD) of the following ECG intervals: QR, QRS, QT, JT, and T peak-T end (Te). The RpT from a standard ECG was calculated. Patients were grouped by the age-stratified Januzzi NT-proBNP cut-off. A total of 140 patients with suspected adCHF were enrolled: 87 (mean age 83 ± 10, M/F 38/49) with and 53 (mean age: 83 ± 9, M/F: 23/30) without adCHF. V5-, V6- (p < 0.05) RpT, and QRSD, QRSSD, QTSD, JTSD, and TeSDp < 0.001 were significantly higher in the adCHF group. Multivariable logistic regression analysis demonstrated that the mean of QT (p < 0.05) and Te (p < 0.05) were the most reliable markers of in-hospital mortality. V6 RpT was directly related to NT-proBNP (r: 0.26, p < 0.001) and inversely related to a left ventricular ejection fraction (r: 0.38, p < 0.001). The intrinsicoid deflection time (obtained from V5-6 and QRSD) could be used as a possible marker of adCHF.

Effect of skin conductivity on the electric field induced by transcranial stimulation techniques in different head models.

This study aims at quantifying the effect that using different skin conductivity values has on the estimation of the electric (E)-field distribution induced by transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) in the brain of two anatomical models. The induced E-field was calculated with numerical simulations inside MIDA and Duke models, assigning to the skin a conductivity value estimated from a multi-layered skin model and three values taken from literature. The effect of skin conductivity variations on the local E-field induced by tDCS in the brain was up to 70%. In TMS, minor local differences, in the order of 20%, were obtained in regions of interest for the onset of possible side effects. Results suggested that an accurate model of the skin is necessary in all numerical studies that aim at precisely estimating the E-field induced during TMS and tDCS applications. This also highlights the importance of further experimental studies on human skin characterization, especially at low frequencies.

Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the AIR registry.

BACKGROUND: Ablation index (AI) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies. This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (PV) isolation guided by the AI. METHODS: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (ST) or contact force surround flow (STSF) catheter) and the AI setting (330-450 or 380-500 at anterior wall or posterior wall, respectively). RESULTS: At 12 months a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs 83.3%; P = .039). There was no difference in the rate of AF recurrence among the four study groups (4.5% in group ST330-450, 12.2% in group ST 380-500, 14.9% in group STSF330-450, 9.4% in group STSF380-500; P = .083). Recurrence was also similar between patients treated with a ST (8%) or STSF catheter (12.1%; P = .2), and within patients targeting an AI settings of 330 to 450 (10.9%) or 380 to 500 (10.3%; P = .64). In patients with paroxysmal AF, there was no difference (P = .12) in the 1-year freedom from AF recurrence among 14 operators that performed ≥10 ablation procedure. CONCLUSIONS: An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of 1-year freedom from AF recurrence, irrespective of the ablation catheters, AI settings, and operator.

Reproducibility of acute pulmonary vein isolation guided by the ablation index.

BACKGROUND: Atrial fibrillation (AF) ablation outcome is still operator dependent. Ablation Index (AI) is a new lesion quality marker that has been demonstrated to allow acute durable pulmonary vein (PV) isolation followed by a high single-procedure arrhythmia-free survival. This prospective, multicenter study was designed to evaluate the reproducibility of acute PV isolation guided by the AI. METHODS: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV encircling and were divided in four study groups according to operator preference in choosing the ablation catheter (a contact force [ST] or contact force surround flow [STSF] catheter) and the AI setting (330 at posterior and 450 at anterior wall or 380 at posterior and 500 at anterior wall). Radiofrequency was delivered targeting interlesion distance ≤6 mm. RESULTS: The rate of first-pass PV isolation (ST330 90 ± 16%, ST380 87 ± 19%, STSF330 90 ± 17%, STSF380 91 ± 15%, P = .585) was similar among the four study groups, whereas procedure (ST330 129 ± 44 minutes, ST380 144 ± 44 minutes, STSF330 120 ± 72 minutes, STSF380 125 ± 73 minutes, P < .001) and fluoroscopy time (ST330 542 ± 285 seconds, ST380 540 ± 416 seconds, STSF330 257 ± 356 seconds, STSF380 379 ± 454 seconds, P < 0.001) significantly differed. The difference in the rate of first-pass isolation was not statistical different (P = .06) among the 12 operators that performed at least 15 procedures. CONCLUSIONS: An ablation protocol respecting strict criteria for contiguity and quality lesion results in high and comparable rate of acute PV isolation among operator performing ablation with different catheters, AI settings, procedure, and fluoroscopy times.

Influence of Anatomical Model and Skin Conductivity on the Electric Field Induced in the Head by Transcranial Magnetic Stimulation.

Numerical evaluation of the electromagnetic (EM) quantities induced inside the brain during transcranial magnetic stimulation (TMS) applications is a fundamental step to obtain the optimization of the treatment in terms of coil position and current intensity. In this sense, the human head model considered and the electromagnetic properties used to characterize the tissues have an influence on the EM solution. Thus, the aim of this study is to evaluate how different skin conductivities and different computational head models, i.e. the ViP Duke and the MIDA, influence the electric field induced inside the brain by a typical TMS coil.

Modelling of induced electric fields based on incompletely known magnetic fields.

Determining the induced electric fields in the human body is a fundamental problem in bioelectromagnetics that is important for both evaluation of safety of electromagnetic fields and medical applications. However, existing techniques for numerical modelling of induced electric fields require detailed information about the sources of the magnetic field, which may be unknown or difficult to model in realistic scenarios. Here, we show how induced electric fields can accurately be determined in the case where the magnetic fields are known only approximately, e.g. based on field measurements. The robustness of our approach is shown in numerical simulations for both idealized and realistic scenarios featuring a personalized MRI-based head model. The approach allows for modelling of the induced electric fields in biological bodies directly based on real-world magnetic field measurements.

Bio-Engineering tissue and V.A.C. therapy: A new method for the treatment of extensive necrotizing infection in the diabetic foot.

AIM: The aim of the study is to compare the standard care for progressive necrotizing infection in diabetic foot with a treatment protocol based on the association between autologous fibroblast grafts and vacuum-assisted closure therapy (V.A.C.). MATERIAL OF STUDY: A retrospective matched Case-Control study was carried out on 20 patients with diabetic foot infection, 10 treated with the standard care and 10 with our new protocol. Inclusion criteria were: acute diabetic foot necrosis (Wagner III and IV), ulcer size (30 to 80 cm2), tendon and bone exposure. Success in the treatment was evaluated as: percentage of healing at the 20th week, time of healing, deambulation, recurrence and major amputation rate. RESULTS: A 90% healing rate was observed after 20 weeks in the study group, compared to a 28.6% in the control group. The recurrence rate in the treated areas was 20% in the study group and 100% in the control group. None of the patients in either group required major amputations. DISCUSSION: We achieved very promising results by associating autologous fibroblasts grafts and V.A.C. therapy, in comparison with standard care. V.A.C. therapy seems to improve the growth rate of the fibroblasts, probably by sealing the wound and providing a moist environment following the fibroblast graft. The improved neoangiogenesis of the neo-dermis could explain the reduced recurrence rate of the study group. CONCLUSIONS: Despite the low number of patients involved and the retrospective nature of the analysis, this study showed a reliable, safe and cost-effective method of treating extensive infection in the diabetic foot. KEY WORDS: Bio-Engineered Tissue, Diabetic foot, Fibroblast graft, V.A.C.

Relationship between peak spatial-averaged specific absorption rate and peak temperature elevation in human head in frequency range of 1-30 GHz.

This study investigates the relationship between the peak temperature elevation and the peak specific absorption rate (SAR) averaged over 10 g of tissue in human head models in the frequency range of 1-30 GHz. As a wave source, a half-wave dipole antenna resonant at the respective frequencies is located in the proximity of the pinna. The bioheat equation is used to evaluate the temperature elevation by employing the SAR, which is computed by electromagnetic analysis, as a heat source. The computed SAR is post-processed by calculating the peak spatial-averaged SAR with six averaging algorithms that consider different descriptions provided in international guidelines and standards, e.g. the number of tissues allowed in the averaging volume, different averaging shapes, and the consideration of the pinna. The computational results show that the SAR averaging algorithms excluding the pinna are essential when correlating the peak temperature elevation in the head excluding the pinna. In the averaging scheme considering an arbitrary shape, for better correlation, multiple tissues should be included in the averaging volume rather than a single tissue. For frequencies higher than 3-4 GHz, the correlation for peak temperature elevation in the head excluding the pinna is modest for the different algorithms. The 95th percentile value of the heating factor as well as the mean and median values derived here would be helpful for estimating the possible temperature elevation in the head.

A novel homogenization procedure to model the skin layers in LF numerical dosimetry.

In this study we focus on the validity of the skin layer currently implemented in up-to-date human-body anatomical models employed in low frequency (LF) numerical dosimetry. Indeed, the several layers of the skin structure, i.e. the stratum corneum (SC), dermis, and epidermis are in these models embedded into a unique fairly-thick (2-3 mm) layer encompassing all of them. While a previous work from the authors showed that for normal-standing (or limb-non-touching) postures a single-layer skin model could conservatively estimate the peak electric field induced in the skin, at least a two-layer skin model comprising of the SC and the remaining skin layers should be used for limb-touching exposure scenarios. This implies notable efforts to discretize the tiny SC layer questioning the validity of current anatomical models. A novel strategy based on the homogenization of the several skin layers has been therefore proposed in order to eliminate the SC from the computational domain opening the doors to future LF magnetic applications even for limb-touching scenarios.

Evaluation of nonuniform field exposures with coupling factors.

In this study, the safety compliance for nonuniform field exposures is discussed using coupling factor concepts. The coupling factor, which is defined in the International Electrotechnical Commission 62311 standard, is extended to consider the effects of harmonics and also to apply to the specific absorption rate (for frequencies up to 30 MHz). The proposed compliance procedure is applied to and demonstrated for a prototype wireless power transfer (WPT) system with induction coupling operating at the fundamental frequency in 140 kHz band. First, measurements confirm that the perturbation of the external magnetic field strength and S11 parameter of a one-loop antenna by a human-equivalent phantom are sufficiently small, suggesting the applicability of the magneto-quasi-static approximation to frequencies up to 30 MHz. Then, the frequency characteristics of the coupling factor are derived for the WPT system. For the prototype system that is not optimized for commercial usage, the maximum allowable transmitting power is relaxed by a factor of 23 with the proposed procedure. The contribution of the harmonics decreased the allowable transmitting power by 39%, indicating their importance for safety compliance.

Inter-subject Variability in Electric Fields of Motor Cortical tDCS.

BACKGROUND: The sources of inter-subject variability in the efficacy of transcranial direct current stimulation (tDCS) remain unknown. One potential source of variations is the brain's electric field, which varies according to each individual's anatomical features. OBJECTIVE: We employed an approach that combines imaging and computational modeling to quantitatively study the extent and primary causes of inter-subject variation in tDCS electric fields. METHODS: Anatomically-accurate models of the head and brain of 24 males (age: 38.63 ± 11.24 years) were constructed from structural MRI. Finite-element method was used to computationally estimate the electric fields for tDCS of the motor cortex. Surface-based inter-subject registration of the electric field and functional MRI data was used for group level statistical analysis. RESULTS: We observed large differences in each individual's electric field patterns. However, group level analysis revealed that the average electric fields concentrated in the vicinity of the primary motor cortex. The variations in the electric fields in the hand motor area could be characterized by a normal distribution with a standard deviation of approximately 20% of the mean. The cerebrospinal fluid (CSF) thickness was the primary factor influencing an individual's electric field, thereby explaining 50% of the inter-individual variability, a thicker layer of CSF decreasing the electric field strength. CONCLUSIONS: The variability in the electric fields is related to each individual's anatomical features and can only be controlled using detailed image processing. Age was found to have a slight negative effect on the electric field, which might have implications on tDCS studies on aging brains.

Human exposure from pulsed magnetic field therapy mats: a numerical case study with three commercial products.

A previous study found that incident magnetic field exposure from pulsed magnetic field therapy (PMFT) mats can exceed ICNIRP 1998 reference levels. Due to the popularity of PMFT mats for private therapeutic use, regulators need to know if the products are compliant with the basic restrictions and how overexposure can be determined. This case study's objective was to test if such products are intrinsically compliant with ICNIRP 1998 and ICNIRP 2010 basic restrictions by evaluating three different commercially-available PMFT products. In the first step, experimentally validated numerical models of these mats were developed. As a second step, the induced fields were evaluated in high-resolution anatomical models of the IT'IS Virtual Population for various lying positions and compared to the safety guidelines. As expected, a strong influence of exposure on the PMFT design, anatomy, lying position and body orientation was found. The maximum exposure of one PMFT exceeds 3.1 times the basic restrictions of ICNIRP 1998 for the central nervous system tissues and 1.36 times the limit of ICNIRP 2010 for the peripheral tissues. Body loops can significantly increase the electric fields close to the skin, e.g., when the hand and thigh are in contact during mat use. In conclusion, PMFT products are not intrinsically compliant with ICNIRP 1998 and ICNIRP 2010 basic restrictions and therefore require special considerations.

Theoretical assessment of the maximum obtainable power in wireless power transfer constrained by human body exposure limits in a typical room scenario.

In this study, the maximum received power obtainable through wireless power transfer (WPT) by a small receiver (Rx) coil from a relatively large transmitter (Tx) coil is numerically estimated in the frequency range from 100 kHz to 10 MHz based on human body exposure limits. Analytical calculations were first conducted to determine the worst-case coupling between a homogeneous cylindrical phantom with a radius of 0.65 m and a Tx coil positioned 0.1 m away with the radius ranging from 0.25 to 2.5 m. Subsequently, three high-resolution anatomical models were employed to compute the peak induced field intensities with respect to various Tx coil locations and dimensions. Based on the computational results, scaling factors which correlate the cylindrical phantom and anatomical model results were derived. Next, the optimal operating frequency, at which the highest transmitter source power can be utilized without exceeding the exposure limits, is found to be around 2 MHz. Finally, a formulation is proposed to estimate the maximum obtainable power of WPT in a typical room scenario while adhering to the human body exposure compliance mandates.

On the issues related to compliance assessment of ICNIRP 2010 basic restrictions.

This article discusses technical issues related to compliance assessment of ICNIRP 2010 basic restrictions. Several difficulties are identified in this study when assessing the spatial average and 99th percentile value of the electric field. These issues are mainly attributed to the lack of clarity in the guideline specifications, which leads to inadequate or irreproducible results. Effects on compliance results due to such ambiguous procedures are hereby investigated, with particular focus on technical issues rather than biological ones. Examples spanning from simple canonical test cases to realistic applications have been selected to highlight the strong variability in dosimetry results. Based on our findings, revisiting the ICNIRP 2010 guidelines is strongly recommended, and proposed alternative solutions are outlined.

On the issues related to compliance of LF pulsed exposures with safety standards and guidelines.

In this paper, procedures to determine compliance of low-frequency pulsed exposures are investigated. Current methods specified by international standards or guidelines (e.g., from the ICNIRP or IEEE) are recognized to be conservative in order to account for uncertainties coming from the assessment procedures. In this way, protection of workers and the general public should be guaranteed. However, overly conservative procedures could hinder the application of technologies employing complex, intermittent, or pulsed waveforms without improving safety. Besides over conservatism, variabilities among the results of several procedures are examined for the first time. These limits pose several concerns on the applicability of the existing compliance formulae. A more stable technique, which is still easy to implement, is therefore proposed.

Analysis of human brain exposure to low-frequency magnetic fields: a numerical assessment of spatially averaged electric fields and exposure limits.

Compliance with the established exposure limits for the electric field (E-field) induced in the human brain due to low-frequency magnetic field (B-field) induction is demonstrated by numerical dosimetry. The objective of this study is to investigate the dependency of dosimetric compliance assessments on the applied methodology and segmentations. The dependency of the discretization uncertainty (i.e., staircasing and field singularity) on the spatially averaged peak E-field values is first determined using canonical and anatomical models. Because spatial averaging with a grid size of 0.5 mm or smaller sufficiently reduces the impact of artifacts regardless of tissue size, it is a superior approach to other proposed methods such as the 99th percentile or smearing of conductivity contrast. Through a canonical model, it is demonstrated that under the same uniform B-field exposure condition, the peak spatially averaged E-fields in a heterogeneous model can be significantly underestimated by a homogeneous model. The frequency scaling technique is found to introduce substantial error if the relative change in tissue conductivity is significant in the investigated frequency range. Lastly, the peak induced E-fields in the brain tissues of five high-resolution anatomically realistic models exposed to a uniform B-field at ICNIRP and IEEE reference levels in the frequency range of 10 Hz to 100 kHz show that the reference levels are not always compliant with the basic restrictions. Based on the results of this study, a revision is recommended for the guidelines/standards to achieve technically sound exposure limits that can be applied without ambiguity.

Safety assessment of ultra-wideband antennas for microwave breast imaging.

This article deals with the safety assessment of several ultra-wideband (UWB) antenna designs for use in prototype microwave breast imaging systems. First, the performances of the antennas are validated by comparison of measured and simulated data collected for a simple test case. An efficient approach to estimating the specific energy absorption (SA) is introduced and validated. Next, SA produced by the UWB antennas inside more realistic breast models is computed. In particular, the power levels and pulse repetition periods adopted for the SA evaluation follow the measurement protocol employed by a tissue sensing adaptive radar (TSAR) prototype system. Results indicate that the SA for the antennas examined is below limits prescribed in standards for exposure of the general population; however, the difficulties inherent in applying such standards to UWB exposures are discussed. The results also suggest that effective tools for the rapid evaluation of new sensors have been developed.