Validation of a novel smartphone-based photoplethysmographic method for ambulatory heart rhythm diagnostics: the SMARTBEATS study.

AIMS: In the current guidelines, smartphone photoplethysmography (PPG) is not recommended for diagnosis of atrial fibrillation (AF), without a confirmatory electrocardiogram (ECG) recording. Previous validation studies have been performed under supervision in healthcare settings, with limited generalizability of the results. We aim to investigate the diagnostic performance of a smartphone-PPG method in a real-world setting, with ambulatory unsupervised smartphone-PPG recordings, compared with simultaneous ECG recordings and including patients with atrial flutter (AFL). METHODS AND RESULTS: Unselected patients undergoing direct current cardioversion for treatment of AF or AFL were asked to perform 1-min heart rhythm recordings post-treatment, at least twice daily for 30 days at home, using an iPhone 7 smartphone running the CORAI Heart Monitor PPG application simultaneously with a single-lead ECG recording (KardiaMobile). Photoplethysmography and ECG recordings were read independently by two experienced readers. In total, 280 patients recorded 18 005 simultaneous PPG and ECG recordings. Sufficient quality for diagnosis was seen in 96.9% (PPG) vs. 95.1% (ECG) of the recordings (P < 0.001). Manual reading of the PPG recordings, compared with manually interpreted ECG recordings, had a sensitivity, specificity, and overall accuracy of 97.7%, 99.4%, and 98.9% with AFL recordings included and 99.0%, 99.7%, and 99.5%, respectively, with AFL recordings excluded. CONCLUSION: A novel smartphone-PPG method can be used by patients unsupervised at home to achieve accurate heart rhythm diagnostics of AF and AFL with very high sensitivity and specificity. This smartphone-PPG device can be used as an independent heart rhythm diagnostic device following cardioversion, without the requirement of confirmation with ECG.

Electrical impedance spectroscopy and the diagnostic accuracy for malignant melanoma.

BACKGROUND: The accuracy of diagnosis of skin cancer and especially of early malignant melanoma is most important to reduce its morbidity and mortality. Previous pilot studies using electrical impedance measurements indicate statistically significant accuracies for the detection of skin cancer. OBJECTIVES: The aim of this study is to investigate the accuracy of electrical impedance spectra to distinguish between malignant melanoma and benign skin lesions using an automated classification algorithm. PATIENTS/METHODS: Electrical impedance spectra were measured in a multi-centre study at 12 clinics around Europe. Data from 285 histologically analysed lesions were used to train an algorithm to sort out lesions for automatic detection of melanoma. Another data cohort of 210 blinded lesions (148 various benign lesions and 62 malignant melanomas where 38 being from Breslow thickness ≤1 mm) from 183 patients was thereafter used to estimate the accuracy of the technique. RESULTS: Observed sensitivity to malignant melanoma is 95% (59/62) and observed specificity 49% (72/148). CONCLUSIONS: The results suggest that electrical impedance spectra can distinguish between malignant melanoma and benign skin lesions. Although it is indicated that the accuracy of the device is clinically promising, the overall performance, and the sensitivity to thin malignant melanomas, must be improved and thoroughly validated before the instrument can be used as a routine stand-alone diagnostic decision support tool. The technique is under revision to further improve the reproducibility, specificity and sensitivity.

Non-invasive bioimpedance of intact skin: mathematical modeling and experiments.

The functional integrity and pathology of the skin is reflected in its electrical impedance spectra. Non-invasive electrical impedance measurements of intact skin are dominated by the high impedic stratum corneum in low frequencies and with increasing frequency gradually comes to be dominated by viable skin. Models of this multi-layered organ can increase our understanding of the actual physical properties/dimensions and facilitate better diagnostics in certain applications. Therefore, a mathematical model considering conservation of charge in the various layers of the skin and adjacent electrodes is derived and validated with experimental findings; the latter was carried out on 60 young female subjects. The impact of the stratum corneum thickness, inundation, solvent and cohort size on the electrical properties is studied. Both model parameters and experimental conditions were adjusted for calibration and subsequent validation of the model with measurements. It is found that both the model's thickness of the stratum corneum as well as experimental soaking conditions (both time and saline concentration) affect the fit between the model and measurements. It is concluded that it is essential that the electrical properties of the skin are presented in the context of the ion concentration (if a moisturizer is employed) as well as the soaking time. Further refinements should be made to determine even more accurate dielectrical properties of the stratum corneum and viable skin layers by accounting for the true skin thickness and the heterogeneity of the skin layers-this would be useful in applications where subtle alterations in the skin are of interest.

Non-invasive and microinvasive electrical impedance spectra of skin cancer - a comparison between two techniques.

BACKGROUND/PURPOSE: Bio-electrical impedance spectra of skin cancer and other lesions can be assessed using both regular non-invasive probes and a novel type of microinvasive electrode system with a surface furnished with tiny spikes that penetrate stratum corneum. The aim of the study was to compare the accuracy of detection for various types of skin cancer using impedance spectra measured with these two different electrode systems in an objective way without optimising the power of discrimination. METHODS: Impedance spectra of 99 benign nevi, 28 basal cell carcinomas (BCC), and 13 malignant melanomas (MM) were measured using the two electrode systems. Classification of the lesions was made using Fisher's linear discriminant, and the sensitivities and specificities of the techniques were estimated using cross-validation. RESULTS: The best separation between nevi and BCC was achieved using the regular non-invasive probe (96% sensitivity and 86% specificity), whereas the best separation between nevi and MM was achieved using the microinvasive electrodes (92% sensitivity and 80% specificity). CONCLUSIONS: Our results indicate that the choice of electrode system is application dependent.

Skin cancer identification using multifrequency electrical impedance--a potential screening tool.

Electrical bio-impedance can be used to assess skin cancers and other cutaneous lesions. The aim of this study was to distinguish skin cancer from benign nevi using multifrequency impedance spectra. Electrical impedance spectra of about 100 skin cancers and 511 benign nevi were measured. Impedance of reference skin was measured ipsi-laterally to the lesions. The impedance relation between lesion and reference skin was used to distinguish the cancers from the nevi. It was found that it is possible to separate malignant melanoma from benign nevi with 75% specificity at 100% sensitivity, and to distinguish nonmelanoma skin cancer from benign nevi with 87% specificity at 100% sensitivity. The power of skin cancer detection using electrical impedance is as good as, or better than, conventional visual screening made by general practitioners.

Effect of angular error on tissue Doppler velocities and strain.

One of the major criticisms of ultrasound Doppler is its angle dependency, that is its ability to measure velocity components directly to or from the transducer only. The present article aims to investigate the impact of this angular error in a clinical setting. Apical two- and four-chamber views were recorded in 43 individuals, and the myocardium was marked by hand in each image. We assume that the main direction of the myocardial velocities is longitudinal and correct for the angular error by backprojecting measured velocities onto the longitudinal direction drawn. Strain was calculated from both corrected and uncorrected velocities in 12 segments for each individual. The results indicate that the difference between strain values calculated from corrected and uncorrected velocities is insignificant in 5 segments and within a decimal range in 11 segments. The biggest difference between measured and corrected strain values was found in the apical segments. Strain is also found to be more robust against angular error than velocities because the difference between corrected and uncorrected values is smaller for strain. Considering that there are multiple sources of noise in ultrasound Doppler measurements, the authors conclude that the angular error has so little impact on longitudinal strain that correction for this error can safely be omitted. (ECHOCARDIOGRAPHY, Volume 20, October 2003)

Assessment of skin lesions and skin cancer using simple electrical impedance indices.

BACKGROUND/AIMS: Purpose of this investigation was to assess benign pigmented cellular nevus (BEN), basal cell carcinoma (BCC), dermatofibroma (DER), dysplastic nevus (DYS), and seborrheic keratoses (SEB) using in vivo non- invasive electrical impedance technique. METHODS: Electrical impedance was measured at 258 BEN, 34 BCC, 17 DER, 35 DYS, and 26 SEB lesions. Controls were measured at healthy skin close to the lesions. The impedance was measured between 1 kHz and 1 MHz at five depth settings. After the impedance measurements the lesions were histopathologically diagnosed. The impedance spectra were parameterized to four indices prior to the statistical analysis of the data. RESULTS: There were significant differences between the lesions and their controls for BEN (P < 0.001), BCC (P < 0.001), DYS (P < 0.01), and SEB (P < 0.01). CONCLUSIONS: There are clear statistical differences between impedance of common lesions and control skin. With some further developments, the impedance technique can be useful as a diagnostic decision support tool for skin cancer assessment.

The use of different concentrations of betaine as a reducing irritation agent in soaps monitored visually and non-invasively.

BACKGROUND/AIMS: Products containing detergents can damage the skin and give rise to irritant contact dermatitis. Therefore, attempts have been made to find less irritating detergents as well as substances decreasing undesired side-effects of detergents, and a novel approach is offered by betaine. The aim of the study has been to determine the irritating properties of some liquid soaps for personal hygiene and to map the effect of different concentrations of betaine using electrical impedance, trans-epidermal water loss and visual inspection. METHODS: Twenty-eight healthy subjects were patch tested with different commercial soaps with and without betaine and sodium lauryl sulphate on both volar forearms for 24 h. A site with distilled water and an unoccluded area were used as references. Responses of the skin reactions were evaluated by visual inspection and by measuring trans-epidermal water loss and electrical impedance before application and 24 h after removal of the chambers. RESULTS/CONCLUSIONS: Significant skin reactions were found for all soaps tested but the soaps containing betaine were the least irritating. However, the skin irritation did not decrease with increasing concentrations of betaine in the tested range. On the whole the differences between the products were not large. The non-invasive methods used were more sensitive than visual assessment for evaluation of invisible or barely visible skin responses.

Variation of skin properties within human forearms demonstrated by non-invasive detection and multi-way analysis.

BACKGROUND/AIM: It is known that the properties of human skin vary locally. The purpose of this study was to investigate the properties of human volar forearms even further using advanced non-invasive techniques and numerical methods. METHODS: The skin properties of human volar forearms were investigated using measurements of trans epidermal water loss and multifrequency electrical impedance. Eight sites on the forearms of 27 healthy volunteers were measured. The sites were oriented as squares, four sites on both left and right forearm, approximately 40-50 mm apart. RESULTS: Analysis of variance showed significant differences for epidermal water loss (P < 0.01) and the skin impedance (P < 0.001) between the inner and outer sides of the arms. Additionally, parallel factor analysis of the full skin impedance spectra also showed that there are systematic differences between right and left arm (P < 0.01). CONCLUSION: It is crucial to design skin studies carefully in order to minimise the effects of the local skin properties of human skin.