Diurnal cardio-respiratory changes in ambulatory individuals deciphered using a multi-parameter wearable device.

Background: Recent technological developments enable big data-driven insights on diurnal changes. This study aimed to describe the trajectory of multiple and advanced parameters using a medical-grade wearable remote patient monitor. Methods: Parameters were monitored for 24 h in 256 ambulatory participants who kept living their normal life. Parameters included heart rate, blood pressure, stroke volume, cardiac index, systemic vascular resistance, blood oxygen saturation, and respiratory rate. Diurnal variations were evaluated, and analyses were stratified based on sex, age, and body mass index. Results: All parameters showed diurnal changes (p < 0.001). Females demonstrated higher heart rate and cardiac index with lower systemic vascular resistance. Obese participants had a higher blood pressure, and lower stroke volume and cardiac index. Systemic vascular resistance was higher among the elderly. Diurnal changes corresponded with awake-sleep hours and differed between sex, age, and body mass index groups. Conclusion: Wearable monitoring platforms could decipher hemodynamic changes in subgroups of individuals, and might help with efforts to provide personalized medicine, pre-symptomatic diagnosis and prevention, and drug development.

Comparing body temperature measurements using the double sensor method within a wearable device with oral and core body temperature measurements using medical grade thermometers-a short report.

Introduction: Body temperature is essential for diagnosing, managing, and following multiple medical conditions. There are several methods and devices to measure body temperature, but most do not allow continuous and prolonged measurement of body temperature. Noninvasive skin temperature sensor combined with a heat flux sensor, also known as the "double sensor" technique, is becoming a valuable and simple method for frequently monitoring body temperature. Methods: Body temperature measurements using the "double sensor" method in a wearable monitoring device were compared with oral and core body temperature measurements using medical grade thermometers, analyzing data from two prospective clinical trials of different clinical scenarios. One study included 45 hospitalized COVID-19 patients in which oral measurements were taken using a hand-held device, and the second included 18 post-cardiac surgery patients in which rectal measurements were taken using a rectal probe. Results: In study 1, Bland-Altman analysis showed a bias of -0.04°C [0.34-(-0.43)°C, 95% LOA] with a correlation of 99.4% (p < 0.001). In study 2, Bland-Altman analysis showed a bias of 0.0°C [0.27-(-0.28)°C, 95% LOA], and the correlation was 99.3% (p < 0.001). In both studies, stratifying patients based on BMI and skin tone showed high accordance in all sub-groups. Discussion: The wearable monitor showed high correlation with oral and core body temperature measurements in different clinical scenarios.

Clinical validation of a wearable respiratory rate device: A brief report.

BACKGROUND: Respiratory rate (RR) is used for the diagnosis and management of medical conditions and can predict clinical changes. Heavy workload, understaffing, and errors related to poor recording make it underutilized. Wearable devices may facilitate its use. METHODS: RR measurements using a wearable photoplethysmography-based monitor were compared with medical grade devices in complementary clinical scenarios: Study one included a comparison to a capnograph in 35 healthy volunteers; Study two included a comparison to a ventilator monitor in 18 ventilated patients; and Study three included a comparison to capnograph in 92 COVID-19 patients with active pulmonary disease. Pearson's correlations and Bland-Altman analysis were used to assess the accuracy and agreement between the measurement techniques, including stratification for Body Mass Index (BMI) and skin tone. Statistical significance was set at p ≤ 0.05. RESULTS: High correlation was found in all studies (r = 0.991, 0.884, and 0.888, respectively, p < 0.001 for all). 95% LOA of ±2.3, 1.7-(-1.6), and ±3.9 with a bias of < 0.1 breaths per minute was found in Bland-Altman analysis in studies 1,2, and 3, respectively. In all, high accordance was found in all sub-groups. CONCLUSIONS: RR measurements using the wearable monitor were highly-correlated with medical-grade devices in various clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT03603860.

Developing a real-time detection tool and an early warning score using a continuous wearable multi-parameter monitor.

Background: Currently-used tools for early recognition of clinical deterioration have high sensitivity, but with low specificity and are based on infrequent measurements. We aimed to develop a pre-symptomatic and real-time detection and warning tool for potential patients' deterioration based on multi-parameter real-time warning score (MPRT-WS). Methods: A total of more than 2 million measurements were collected, pooled, and analyzed from 521 participants, of which 361 were patients in general wards defined at high-risk for deterioration and 160 were healthy participants allocation as controls. The risk score stratification was based on cutoffs of multiple physiological parameters predefined by a panel of specialists, and included heart rate, blood oxygen saturation (SpO2), respiratory rate, cuffless systolic and diastolic blood pressure (SBP and DBP), body temperature, stroke volume (SV), cardiac output, and systemic vascular resistance (SVR), recorded every 5 min for a period of up to 72 h. The data was used to define the various risk levels of a real-time detection and warning tool, comparing it with the clinically-used National Early Warning Score (NEWS). Results: When comparing risk levels among patients using both tools, 92.6%, 6.1%, and 1.3% of the readings were defined as "Low", "Medium", and "High" risk with NEWS, and 92.9%, 6.4%, and 0.7%, respectively, with MPRT-WS (p = 0.863 between tools). Among the 39 patients that deteriorated, 30 patients received 'High' or 'Urgent' using the MPRT-WS (42.7 ± 49.1 h before they deteriorated), and only 6 received 'High' score using the NEWS. The main abnormal vitals for the MPRT-WS were SpO2, SBP, and SV for the "Urgent" risk level, DBP, SVR, and SBP for the "High" risk level, and DBP, SpO2, and SVR for the "Medium" risk level. Conclusion: As the new detection and warning tool is based on highly-frequent monitoring capabilities, it provides medical teams with timely alerts of pre-symptomatic and real-time deterioration.

A second-generation artificial intelligence-based therapeutic regimen improves diuretic resistance in heart failure: Results of a feasibility open-labeled clinical trial.

INTRODUCTION: Diuretics are a mainstay therapy for congestive heart failure (CHF); however, over one-third of patients develop diuretic resistance. Second-generation artificial intelligence (AI) systems introduce variability into treatment regimens to overcome the compensatory mechanisms underlying the loss of effectiveness of diuretics. This open-labeled, proof-of-concept clinical trial sought to investigate the ability to improve diuretic resistance by implementing algorithm-controlled therapeutic regimens. METHODS: Ten CHF patients with diuretic resistance were enrolled in an open-labeled trial where the Altus Care™ app managed diuretics' dosage and administration times. The app provides a personalized therapeutic regimen creating variability in dosages and administration times within pre-defined ranges. Response to therapy was measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, 6-minute walk test (SMW), N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, and renal function. RESULTS: The second-generation, AI-based, personalized regimen alleviated diuretic resistance. All evaluable patients demonstrated clinical improvement within ten weeks of intervention. A dose reduction (based on a three-week average before and last three weeks of intervention) was achieved in 7/10 patients (70 %, p = 0.042). The KCCQ score improved in 9/10 (90 %, p = 0.002), the SMW improved in 9/9 (100 %, p = 0.006), NT-proBNP was decreased in 7/10 (70 %, p = 0.02), and serum creatinine was decreased in 6/10 (60 %, p = 0.05). The intervention was associated with reduced number of emergency room visits and the number of CHF-associated hospitalizations. SUMMARY: The results support that the randomization of diuretic regimens guided by a second-generation personalized AI algorithm improves the response to diuretic therapy. Prospective controlled studies are needed to confirm these findings.

A feasibility study using sodium alginate injection for penetrating abdominal trauma in a swine model.

Penetrating abdominal injury is a major cause of death in trauma. Sodium alginate hydrogel, a hemostatic agent, offers a platform for targeting both mechanical and biological injuries. The current study assessed the effect of Very Low Viscosity (high) G (VLVG) alginate following abdominal trauma in a swine model of penetrating abdominal injury. Seven anesthetized pigs were instrumented with invasive monitoring catheters and abdominal trauma was introduced by laparoscopic hepatectomy. Ten minutes after the induction of hypovolemic shock, three animals were intra-abdominally administered with VLVG alginate (study group) and four animals with saline (control group). During 8 h of continuous monitoring, various hemodynamic and biochemical variables were measured and liver biopsies for histological evaluation were taken. Hemodynamically, VLVG alginate-treated animals were more stable than controls, as reflected by their lower heart rate and higher blood pressure (p < 0.05 for both). They also had lower levels of liver enzymes and lactate, and less histopathological damage. We show that VLVG alginate might be a promising new agent for reducing penetrating intra-abdominal injury, with hemostatic and biocompatibility efficiency, and tissue preserving properties. Future effort of integrating it with a dispersal device may turn it into a valuable pre-hospital emergency tool to improve survival of trauma casualties.

Influence of Sex, BMI, and Skin Color on the Accuracy of Non-Invasive Cuffless Photoplethysmography-Based Blood Pressure Measurements.

Vital signs obtained by photoplethysmography-based devices might be influenced by subcutaneous fat and skin color. This observational comparison study aimed to test the accuracy of blood pressure (BP) measurements between a photoplethysmography-based device and cuff-based BP device in ambulatory individuals, coming for a routine BP checkup. Systolic BP (SBP) and diastolic BP (DBP) measurements were stratified based on sex, BMI (<25; 25 ≤BMI<30; 30 ≤kg/m2), and skin color (types 1-3 and 4-6 by the Fitzpatrick scale). A total of 1548 measurements were analyzed. Correlations of SBP and DBP between the devices among males/females were between 0.914-0.987 (p < 0.001), and Bland-Altman analysis showed a bias of less than 0.5 mmHg for both sexes. Correlations of SBP and DBP between the devices among BMI groups were between 0.931-0.991 (p < 0.001), and Bland-Altman analysis showed a bias of less than 1 mmHg for all. Correlations of SBP and DBP between the devices among the skin color groups were between 0.936-0.983 (p < 0.001), and Bland-Altman analysis showed a bias of less than 1 mmHg for all. This study shows similar and high agreements between BP measurements obtained using a PPG-based non-invasive cuffless BP device and a cuff-based BP device across sex, BMI, and skin color groups.

Comparing Cardiac Output Measurements Using a Wearable, Wireless, Noninvasive Photoplethysmography-Based Device to Pulse Contour Cardiac Output in the General ICU: A Brief Report.

OBJECTIVES: Cardiac output (CO) measurements in the ICU are usually based on invasive techniques, which are technically complex and associated with clinical complications. This study aimed to compare CO measurements obtained from a noninvasive photoplethysmography-based device to a pulse contour cardiac output device in ICU patients. DESIGN: Observational, prospective, comparative clinical trial. SETTING: Single-center general ICU. PATIENTS: Patients admitted to the general ICU monitored using a pulse contour cardiac output device as per the decision of the attending physician. INTERVENTIONS: Parallel monitoring of CO using a photoplethysmography-based chest patch device and pulse contour cardiac output while the medical team was blinded to the values obtained by the noninvasive device. MEASUREMENTS AND MAIN RESULTS: Seven patients (69 measurements) were included in the final analysis. Mean CO were 7.3 ± 2.0 L/m and 7.0 ± 1.5 L/m for thermodilution and photoplethysmography, respectively. Bland-Altman showed that the photoplethysmography has a bias of 0.3 L/m with -1.6 and 2.2 L/m 95% limit of agreement (LOA) and a bias of 2.4% with 95% LOA between -25.7% and 30.5% when calculating the percentage of difference from thermodilution. The values obtained by thermodilution and photoplethysmography were highly correlated (r = 0.906). CONCLUSIONS: The tested chest patch device offers a high accuracy for CO compared to data obtained by the pulse contour cardiac output and the thermodilution method in ICU patients. Such devices could offer advanced monitoring capabilities in a variety of clinical settings, without the complications of invasive devices.

Management of heart failure with reduced ejection fraction: challenges in patients with atrial fibrillation, renal disease and in the elderly.

Heart failure with reduced ejection fraction (HFrEF) is an increasing global pandemic affecting more than 30 million individuals worldwide. Importantly, HFrEF is frequently accompanied by the presence of cardiac and non-cardiac comorbidities that may greatly influence the management and prognosis of the disease. In this review article, we will focus on three important comorbidities in HFrEF; atrial fibrillation (AF), advanced renal disease, and elderly, which all have a paramount impact on progression of the disease, management strategies, and response to therapy. AF is very common in HFrEF and shares many risk factors. AF aggravates heart failure and contributes to HF-related adverse clinical outcomes; hence it requires special consideration in HFrEF management. The kidney function is largely affected by the reduced cardiac output developed in the setting of HFrEF, and the neurohormonal feedback effects create a complex interplay that pose challenges in the management of HFrEF when renal function is significantly impaired. Cardiorenal syndrome is a challenging sequela with increased morbidity and mortality thereby reflecting the delicate and complex balance between the heart and the kidney in HFrEF and renal failure conditions. Furthermore, patients with advanced renal failure have poor prognosis in the presence of HFrEF with limited treatment options. Finally, aging and frailty are important factors that influence treatment strategies in HFrEF with greater emphasis on tolerability and safety of the various HFrEF therapies in elderly individuals.

Advanced Hemodynamic Monitoring Allows Recognition of Early Response Patterns to Diuresis in Congestive Heart Failure Patients.

There are no clear guidelines for diuretic administration in heart failure (HF), and reliable markers are needed to tailor treatment. Continuous monitoring of multiple advanced physiological parameters during diuresis may allow better differentiation of patients into subgroups according to their responses. In this study, 29 HF patients were monitored during outpatient intravenous diuresis, using a noninvasive wearable multi-parameter monitor. Analysis of changes in these parameters during the course of diuresis aimed to recognize subgroups with different response patterns. Parameters did not change significantly, however, subgroup analysis of the last quartile of treatment showed significant differences in cardiac output, cardiac index, stroke volume, pulse rate, and systemic vascular resistance according to gender, and in systolic blood pressure according to habitus. Changes in the last quartile could be differentiated using k-means, a technique of unsupervised machine learning. Moreover, patients' responses could be best clustered into four groups. Analysis of baseline parameters showed that two of the clusters differed by baseline parameters, body mass index, and diabetes status. To conclude, we show that physiological changes during diuresis in HF patients can be categorized into subgroups sharing similar response trends, making noninvasive monitoring a potential key to personalized treatment in HF.

Exploring Early Pre-Symptomatic Detection of Influenza Using Continuous Monitoring of Advanced Physiological Parameters during a Randomized Controlled Trial.

Early detection of influenza may improve responses against outbreaks. This study was part of a clinical study assessing the efficacy of a novel influenza vaccine, aiming to discover distinct, highly predictive patterns of pre-symptomatic illness based on changes in advanced physiological parameters using a novel wearable sensor. Participants were frequently monitored 24 h before and for nine days after the influenza challenge. Viral load was measured daily, and self-reported symptoms were collected twice a day. The Random Forest classifier model was used to classify the participants based on changes in the measured parameters. A total of 116 participants with ~3,400,000 data points were included. Changes in parameters were detected at an early stage of the disease, before the development of symptomatic illness. Heart rate, blood pressure, cardiac output, and systemic vascular resistance showed the greatest changes in the third post-exposure day, correlating with viral load. Applying the classifier model identified participants as flu-positive or negative with an accuracy of 0.81 ± 0.05 two days before major symptoms appeared. Cardiac index and diastolic blood pressure were the leading predicting factors when using data from the first and second day. This study suggests that frequent remote monitoring of advanced physiological parameters may provide early pre-symptomatic detection of flu.

Contemporary Pillars of Heart Failure with Reduced Ejection Fraction Medical Therapy.

Heart failure with reduced ejection fraction (HFrEF) is a clinical condition associated with cardiac contractility impairment. HFrEF is a significant public health issue with a high morbidity and mortality burden. Pathological left ventricular (LV) remodeling and progressive dilatation are hallmarks of HFrEF pathogenesis, ultimately leading to adverse clinical outcomes. Therefore, cardiac remodeling attenuation has become a treatment goal and a standard of care over the last three decades. Guideline-directed medical therapy mainly targeting the sympathetic nervous system and the renin-angiotensin-aldosterone system (RAAS) has led to improved survival and a reduction in HF hospitalization in this population. More recently, novel pharmacological therapies targeting other pathways implicated in the pathophysiology of HFrEF have emerged at an exciting rate, with landmark clinical trials demonstrating additive clinical benefits in patients with HFrEF. Among these novel therapies, angiotensin receptor-neprilysin inhibitors (ARNI), sodium-glucose cotransporter-2 inhibitors (SGLT2i), vericiguat (a novel oral guanylate cyclase stimulator), and omecamtiv mecarbil (a selective cardiac myosin activator) have shown improved clinical benefit when added to the traditional standard-of-care medical therapy in HFrEF. These new comprehensive data have led to a remarkable change in the medical therapy paradigm in the setting of HFrEF. This article will review the pivotal studies involving these novel agents and present a suggestive paradigm of pharmacological therapy representing the 2021 European Society of Cardiology (ESC) guidelines for the treatment of chronic HFrEF.

In Search of Clinical Impact: Advanced Monitoring Technologies in Daily Heart Failure Care.

Despite significant advances in the management of heart failure (HF), further improvement in the outcome of this chronic and progressive disease is still considered a major unmet need. Recurrent hospitalizations due to decompensated HF frequently occur, resulting in increased morbidity and mortality rates. Past attempts at early detection of clinical deterioration were mainly based on monitoring of signs and symptoms of HF exacerbation, which have mostly given disappointing results. Extensive research of the pathophysiology of HF decompensation has indicated that hemodynamic alterations start days prior to clinical manifestation. Novel technologies aim to monitor these minute hemodynamic changes, allowing time for therapeutic interventions to prevent hemodynamic derangement and HF exacerbation. The latest noticeable advancements include assessment of lung fluid volume, wearable devices with integrated sensors, and microelectromechanical systems-based implantable devices for continuous measurement of cardiac filling pressures. This manuscript will review the rationale for monitoring HF patients and discuss previous and ongoing attempts to develop clinically meaningful monitoring devices to improve daily HF health care, with particular emphasis on the recent advances and clinical trials relevant to this evolving field.

Continuous Remote Patient Monitoring Shows Early Cardiovascular Changes in COVID-19 Patients.

COVID-19 exerts deleterious cardiopulmonary effects, leading to a worse prognosis in the most affected. This retrospective multi-center observational cohort study aimed to analyze the trajectories of key vitals amongst hospitalized COVID-19 patients using a chest-patch wearable providing continuous remote patient monitoring of numerous vital signs. The study was conducted in five COVID-19 isolation units. A total of 492 COVID-19 patients were included in the final analysis. Physiological parameters were measured every 15 min. More than 3 million measurements were collected including heart rate, systolic and diastolic blood pressure, cardiac output, cardiac index, systemic vascular resistance, respiratory rate, blood oxygen saturation, and body temperature. Cardiovascular deterioration appeared early after admission and in parallel with changes in the respiratory parameters, showing a significant difference in trajectories within sub-populations at high risk. Early detection of cardiovascular deterioration of COVID-19 patients is achievable when using frequent remote patient monitoring.

A Pilot Study of Blood Pressure Monitoring After Cardiac Surgery Using a Wearable, Non-invasive Sensor.

Background: Continuous blood pressure (BP) measurement in intensive care units is based on arterial line (AL) transducers, sometimes associated with clinical complications. Our objective was to evaluate continuous BP measurements obtained from a non-invasive, wireless photoplethysmography (PPG)-based device using two distinct configurations (wristwatch and chest-patch monitors) compared to an AL. Methods: In this prospective evaluation study, comparison of the PPG-based devices to the AL was conducted in 10 patients immediately following cardiac surgery. Pulse rate (PR), systolic BP (SBP), diastolic BP (DBP), and mean arterial pressure (MAP) were recorded using both the AL and the PPG-based devices simultaneously for an average of 432 ± 290 min starting immediately after cardiac surgery. Bland-Altman plots and Pearson's correlations were used to assess the accuracy and degree of agreement between techniques. Results: A total of ~4,000 data points were included in the final analysis. AL measurements for PR, SBP, DBP and MAP were significantly (p < 0.001) and strongly correlated with both the wristwatch (r = 0.99, r = 0.94, r = 0.93 and r = 0.96, respectively) and the chest-patch (r = 0.99, r = 0.95, r = 0.93 and r = 0.95, respectively) monitors. Both configurations showed a marginal bias of <1 mmHg for BP measurements and <1 beat/min for PR [95% limits of agreement -3,3 beat/min; BP measurements: (-6)-(-10), 6-10 mmHg] compared to AL measurements. Conclusion: The PPG-based devices offer a high level of accuracy for cardiac-related parameters compared to an AL in post-cardiac surgery patients. Such devices could provide advanced monitoring capabilities in a variety of clinical settings, including immediate post-operative and intensive care unit settings. Clinical Trial Registration:www.clinicaltrials.gov, NCT03603860.

Twenty-Four-Hour Ambulatory Blood Pressure Measurement Using a Novel Noninvasive, Cuffless, Wireless Device.

BACKGROUND: Ambulatory blood pressure monitoring (ABPM) using cuff-based devices is used for diagnosis and treatment of hypertension. Technical limitations, low compliance, and complex procedures limit their use. The aim of the present study was to test the accuracy of a new photoplethysmography-based, wearable device (Wrist-monitor) as compared with the standard cuff-based ABPM device. METHODS: Twenty-four-hour (24H) ABPM was performed in parallel for both devices on volunteers aged 18-65 years, while documenting their daily activities. Level of comfort and activity disturbance of both devices were recorded. Linear regression and Bland-Altman were used to evaluate the agreement between devices. Receiver operating characteristic (ROC) curve analysis was used to classify hypertension based on the average Wrist-monitor measurements as compared with a cuff-based ABPM device. RESULTS: The study included 28 subjects (18 men) mean age 41.5 ± 16.2 years. Bland-Altman analysis resulted in 24H bias of -1.1 mm Hg for both diastolic blood pressure (DBP) and systolic blood pressure (SBP). Mean daytime bias was -1.9 mm Hg for DBP and SBP, while nighttime bias was smaller (0.7 and 0.4 mm Hg for DBP and SBP, respectively). ROC curve analysis yielded a mean area under the curve (AUC) of 1 for SBP and 24H blood pressure measurements. AUCs of 0.994 and 0.955 were found for the daytime DBP and night DBP, respectively. 24H ABPM with the Wrist-monitor caused significantly less inconvenience compared with the cuff-based device (P < 0.001). CONCLUSIONS: The cuffless device provides comparable measurements to those obtained with the currently used cuff-based ABPM device, with significantly less inconvenience to the subject. CLINICAL TRIALS REGISTRATION: Trial Number NCT03810586.

Remote ischemic preconditioning improves tissue oxygenation in a porcine model of controlled hemorrhage without fluid resuscitation.

Remote ischemic preconditioning (RIPC) involves deliberate, brief interruptions of blood flow to increase the tolerance of distant critical organs to ischemia. This study tests the effects of limb RIPC in a porcine model of controlled hemorrhage without replacement therapy simulating an extreme field situation of delayed evacuation to definitive care. Twenty-eight pigs (47 ± 6 kg) were assigned to: (1) control, no procedure (n = 7); (2) HS = hemorrhagic shock (n = 13); and (3) RIPC + HS = remote ischemic preconditioning followed by hemorrhage (n = 8). The animals were observed for 7 h after bleeding without fluid replacement. Survival rate between animals of the RIPC + HS group and those of the HS group were similar (HS, 6 of 13[46%]-vs-RIPC + HS, 4 of 8[50%], p = 0.86 by Chi-square). Animals of the RIPC + HS group had faster recovery of mean arterial pressure and developed higher heart rates without complications. They also had less decrease in pH and bicarbonate, and the increase in lactate began later. Global oxygen delivery was higher, and tissue oxygen extraction ratio lower, in RIPC + HS animals. These improvements after RIPC in hemodynamic and metabolic status provide essential substrates for improved cellular response after hemorrhage and reduction of the likelihood of potentially catastrophic consequences of the accompanying ischemia.

Hemopneumothorax detection through the process of artificial evolution - a feasibility study.

BACKGROUND: Tension pneumothorax is one of the leading causes of preventable death on the battlefield. Current prehospital diagnosis relies on a subjective clinical impression complemented by a manual thoracic and respiratory examination. These techniques are not fully applicable in field conditions and on the battlefield, where situational and environmental factors may impair clinical capabilities. We aimed to assemble a device able to sample, analyze, and classify the unique acoustic signatures of pneumothorax and hemothorax. METHODS: Acoustic data was obtained with simultaneous use of two sensitive digital stethoscopes from the chest wall of an ex-vivo porcine model. Twelve second samples of acoustic data were obtained from the in-house assembled digital stethoscope system during mechanical ventilation. The thoracic cavity was injected with increasing volumes of 200, 400, 600, 800, and 1000 ml of air or saline to simulate pneumothorax and hemothorax, respectively. The data was analyzed using a multi-objective genetic algorithm that was used to develop an optimal mathematical detector through the process of artificial evolution, a cutting-edge approach in the artificial intelligence discipline. RESULTS: The in-house assembled dual digital stethoscope system and developed genetic algorithm achieved an accuracy, sensitivity and specificity ranging from 64 to 100%, 63 to 100%, and 63 to 100%, respectively, in classifying acoustic signal as associated with pneumothorax or hemothorax at fluid injection levels of 400 ml or more, and regardless of background noise. CONCLUSIONS: We present a novel, objective device for rapid diagnosis of potentially lethal thoracic injuries. With further optimization, such a device could provide real-time detection and monitoring of pneumothorax and hemothorax in battlefield conditions.

Novel technologies in the management of heart failure with preserved ejection fraction: a promise during the time of disappointment from pharmacological approaches?

PURPOSE OF REVIEW: Despite numerous attempts, none of a wide variety of tested drugs achieved meaningful improvement in the outcomes of heart failure with preserved ejection fraction (HFpEF), making new therapeutic strategies a major unmet medical need. The medical device industry embraced the challenge, developing novel technologies directed to face specific aspects of the pathophysiology of HFpEF. This review focuses on some of the most promising technologies attaining meaningful clinical progress recently in the field of HFpEF therapy. RECENT FINDINGS: Implantable pulmonary artery pressure, monitoring for optimization of medical therapy, proved to be beneficial in heart failure admissions in a large postmarketing clinical study. Investigational devices, such as inter-atrial shunts and transvenous phrenic nerve stimulators for the treatment of central sleep apnea with Cheyne-Stokes breathing, are currently being evaluated in HFpEF cohorts in recent trials. SUMMARY: Device-based therapies for HFpEF demonstrated encouraging safety and efficacy results in various stages of the disease. Further efforts are needed to ensure that these devices will reach clinical use and contribute to the management of HFpEF patients.