An Era of Digital Healthcare-A Comprehensive Review of Sensor Technologies and Telehealth Advancements in Chronic Heart Failure Management.

Heart failure (HF) is a multi-faceted, complex clinical syndrome characterized by significant morbidity, high mortality rate, reduced quality of life, and rapidly increasing healthcare costs. A larger proportion of these costs comprise both ambulatory and emergency department visits, as well as hospital admissions. Despite the methods used by telehealth (TH) to improve self-care and quality of life, patient outcomes remain poor. HF management is associated with numerous challenges, such as conflicting evidence from clinical trials, heterogeneity of TH devices, variability in patient inclusion and exclusion criteria, and discrepancies between healthcare systems. A growing body of evidence suggests there is an unmet need for increased individualization of in-hospital management, continuous remote monitoring of patients pre and post-hospital admission, and continuation of treatment post-discharge in order to reduce re-hospitalizations and improve long-term outcomes. This review summarizes the current state-of-the-art for HF and associated novel technologies and advancements in the most frequently used types of TH (implantable sensors), categorizing devices in their preclinical and clinical stage, bench-to-bedside implementation challenges, and future perspectives on remote HF management to improve long-term outcomes of HF patients. The Review also highlights recent advancements in non-invasive remote monitoring technologies demonstrated by a few pilot observational prospective cohort studies.

The Prevalence and Correlates of Diabetes Distress among South Asians Living in New York City (NYC): Baseline Results from a Randomized Trial.

Background: Type 2 diabetes (T2D) disproportionately affects South Asians in the United States (US). Living with T2D can be challenging due to the distress it can create for an individual. Distress associated with diabetes, commonly known as diabetes distress (DD), may lead to complications and challenges with the management of diabetes. This study aims to describe the prevalence of DD among a sample of South Asians in New York City (NYC) seeking care in community-based primary care settings and its association with sociodemographic characteristics and clinical measures. Methods: This study utilized baseline data from the Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, an intervention designed to reduce hemoglobin A1C (HbA1c) among South Asians with uncontrolled T2D in NYC. DD was measured using the Diabetes Distress Scale (DDS). First, descriptive statistics were used to analyze sociodemographic variables. Chi-square tests assessed categorical variables and Wilcoxon Rank Sum tests assessed continuous variables using a Type I error rate of 0.05. Logistic regression was performed to determine if HbA1c and mental health, along with other covariates, were associated with dichotomized DDS subscales. Results: Overall, 415 participants completed the DDS at baseline. Median age was 56 years (IQR: 48-62). A total of 25.9% had high emotional burden distress, 6.6% had high physician-related distress, and 22.2% had high regimen-related distress based on subscales. In adjusted analyses, individuals with any days of poor mental health had significantly higher odds of overall distress (OR:3.7, p=0.014), emotional burden distress (OR:4.9, p<0.001), and physician-related distress (OR:5.0, p=0.002) compared to individuals with no days of poor mental health. Individuals with higher HbA1c had significantly higher odds of regimen-related distress (OR:1.31, p=0.007). Conclusions: Findings suggest that DD is prevalent among this sample of South Asians with diagnosed T2D in NYC. Screening for DD in patients with prediabetes/diabetes should be considered by providers to help provide mental and physical health services during primary care visits. Future research can also benefit from a longitudinal analysis of the impact of DD on diabetes self-management, medication adherence, and mental and physical health. Trial registration: This study uses baseline data from "Diabetes Management Intervention For South Asians" (NCT03333044), which was registered with clinicaltrials.gov on 6/11/2017.

Design and Haemodynamic Analysis of a Novel Anchoring System for Central Venous Pressure Measurement.

BACKGROUND/OBJECTIVE: In recent years, treatment of heart failure patients has proved to benefit from implantation of pressure sensors in the pulmonary artery (PA). While longitudinal measurement of PA pressure profoundly improves a clinician's ability to manage HF, the full potential of central venous pressure as a clinical tool has yet to be unlocked. Central venous pressure serves as a surrogate for the right atrial pressure, and thus could potentially predict a wider range of heart failure conditions. However, it is unclear if current sensor anchoring methods, designed for the PA, are suitable to hold pressure sensors safely in the inferior vena cava. The purpose of this study was to design an anchoring system for accurate apposition in inferior vena cava and evaluate whether it is a potential site for central venous pressure measurement. MATERIALS AND METHODS: A location inferior to the renal veins was selected as an optimal site based on a CT scan analysis. Three anchor designs, a 10-strut anchor, and 5-struts with and without loops, were tested on a custom-made silicone bench model of Vena Cava targeting the infra-renal vena cava. The model was connected to a pulsatile pump system and a heated water bath that constituted an in-vitro simulation unit. Delivery of the inferior vena cava implant was accomplished using a preloaded introducer and a dilator as a push rod to deploy the device at the target area. The anchors were subjected to manual compression tests to evaluate their stability against dislodgement. Computational Fluid Dynamics (CFD) analysis was completed to characterize blood flow in the anchor's environment using pressure-based transient solver. Any potential recirculation zones or disturbances in the blood flow caused by the struts were identified. RESULTS: We demonstrated successful anchorage and deployment of the 10-strut anchor in the Vena Cava bench model. The 10-strut anchor remained stable during several compression attempts as compared with the other two 5-strut anchor designs. The 10-strut design provided the maximum number of contact points with the vessel in a circular layout and was less susceptible to movement or dislodgement during compression tests. Furthermore, the CFD simulation provided haemodynamic analysis of the optimum 10-strut anchor design. CONCLUSIONS: This study successfully demonstrated the design and deployment of an inferior vena cava anchoring system in a bench test model. The 10-strut anchor is an optimal design as compared with the two other 5-strut designs; however, substantial in-vivo experiments are required to validate the safety and accuracy of such implants. The CFD simulation enabled better understanding of the haemodynamic parameters and any disturbances in the blood flow due to the presence of the anchor. The ability to place a sensor technology in the vena cava could provide a simple and minimally invasive approach for heart failure patients.

Accessing Artificial Intelligence for Fetus Health Status Using Hybrid Deep Learning Algorithm (AlexNet-SVM) on Cardiotocographic Data.

Artificial intelligence is serving as an impetus in digital health, clinical support, and health informatics for an informed patient's outcome. Previous studies only consider classification accuracies of cardiotocographic (CTG) datasets and disregard computational time, which is a relevant parameter in a clinical environment. This paper proposes a modified deep neural algorithm to classify untapped pathological and suspicious CTG recordings with the desired time complexity. In our newly developed classification algorithm, AlexNet architecture is merged with support vector machines (SVMs) at the fully connected layers to reduce time complexity. We used an open-source UCI (Machine Learning Repository) dataset of cardiotocographic (CTG) recordings. We divided 2126 CTG recordings into 3 classes (Normal, Pathological, and Suspected), including 23 attributes that were dynamically programmed and fed to our algorithm. We employed a deep transfer learning (TL) mechanism to transfer prelearned features to our model. To reduce time complexity, we implemented a strategy wherein layers in the convolutional base were partially trained to leave others in the frozen states. We used an ADAM optimizer for the optimization of hyperparameters. The presented algorithm also outperforms the leading architectures (RCNNs, ResNet, DenseNet, and GoogleNet) with respect to real-time accuracies, sensitivities, and specificities of 99.72%, 96.67%, and 99.6%, respectively, making it a viable candidate for clinical settings after real-time validation.

Utilizing Policy and Electronic Health Record (EHR) System Modifications to Implement and Sustain Routine Opt-Out HIV Screening and Linkage to Care During the COVID-19 Pandemic.

The burden of HIV infection disproportionately impacts Black people across the United States. New York City (NYC) has taken substantial steps to End the HIV Epidemic, boasting reductions in new HIV infections by 40% since 2015; however, racial inequities persist. In 2019, Black people living in NYC accounted for 24% of the population, yet represented 46.1% of new HIV diagnoses and 48.7% of HIV deaths. To address the high incidence of HIV in a predominately Black community in Central Brooklyn, Brookdale Hospital Medical Center (BHMC) developed a multi-faceted approach to increase routine opt-out HIV screening and linkage. In order to integrate HIV testing into routine clinical care, BHMC leadership updated screening policies; developed an Electronic Health Record (EHR) algorithm to trigger HIV screening in five BHMC ambulatory clinics; and modified the EHR to transmit positive HIV screening results to patient navigators dedicated to linking patients to HIV care. During the height of the COVID-19 pandemic, between March and April 2020, HIV screening across all five ambulatory sites decreased by 87.3%. After activation of the EHR algorithm in three ambulatory sites in June 2020, HIV screening increased 216.3% from the prior month. By the time the final EHR algorithm launched in August 2020, HIV testing had fully rebounded to pre-pandemic levels. Policies supporting routine opt-out HIV screening coupled with EHR-prompted screening can improve and sustain HIV testing in a Black community with a high incidence and prevalence of HIV.

Recent trends in renal denervation devices for resistant hypertension treatment.

Hypertension is one of the most important risk factors for cardiovascular disease, which is the leading cause of mortality. The World Health Organization (WHO) estimated that in 2019 more than 1.13 billion people worldwide were suffering from hypertension. In spite of the advances in new medical therapies, control of hypertension remains suboptimal. Renal denervation (RDN) neuromodulation treatment was primarily developed to treat resistant hypertension and is potentially a new method for treating congestive heart failure, diabetes, and chronic renal failure. RDN consists of passing a catheter into the renal arteries and ablating their sympathetic nerves using radiofrequency or ultrasound energy. Despite promising results in initial trials, RDN failed to achieve its efficacy endpoints as a treatment for resistant hypertension, but the recent series of successful trials show that RDN is back as a serious treatment alternative. This paper reviews the current state-of-the-art RDN devices including Symplicity Flex, Symplicity Spyral, Vessix, EnligHTN, Iberis, TIVUS system, and Paradise. The paper also provides an in-depth review of future RDN devices which include Cryo-RDN, Golden Leaf Catheter, Synaptic, SyMapCath, ConfidenHT System, and Grizzly Microwave Ablation system.

Determination of optimal implantation site in central venous system for wireless hemodynamic monitoring.

BACKGROUND/PURPOSE: In recent years, treatment of heart failure patients has proved to benefit from implantation of pressure sensors in the pulmonary artery. Despite this, pulmonary artery pressure is related to the left ventricle, and cannot provide information on the right side of the heart. By contrast, pressure in the central venous system is directly connected to the right atrium and could potentially predict a wider range of heart failure conditions. The purpose of this work is to find an optimal site for implantation in the central venous system of a hemodynamic wireless sensor for heart failure monitoring. Since all previous hemodynamic sensors were located in the pulmonary artery, there is no existing information about an optimal site in the central venous system. METHODS: This study analysed data obtained from CT scans of most relevant anatomical features in the inferior vena cava. The most important parameters of the sites of interest were extracted, analysed statistically and compared, with the purpose to select an optimal site of implantation. RESULTS: The results obtained show that the area comprised between the iliac bifurcation and the lower renal vein (and between the second and third lumbar veins) is the most suitable site of implantation for a hemodynamic sensor. Parameters such as its straight anatomy, diameter (21 mm) and link distance (106 mm) present it as a convenient location for implantation. Its procedure appears relatively easy, as access from the femoral vein is close to the site of interest. In addition, there are not major delicate structure in its surroundings that may pose a risk to the patient. CONCLUSION: This study concludes that the area between the iliac join and the lower renal vein (and the 2nd and 3rd lumbar veins) is an optimal site for the accommodation of a hemodynamic sensor.

A novel wireless implant for central venous pressure measurement: First animal experience.

Background/Objective: Central venous pressure (CVP) serves as a surrogate for right atrial pressure, and thus could potentially predict a wider range of heart failure conditions. The purpose of this work is to assess CVP, through an implantable sensor incorporated with a novel anchor design, in the inferior and superior vena cava of an animal model. Methods: Two animals (Dorset sheep) were implanted with sensors at 3 different locations: inferior vena cava (IVC), superior vena cava (SVC), and pulmonary artery (PA). Two sensors with distinct anchor designs considering anatomical requirements were used. A standard PA sensor (trade name Cordella) was deployed in the PA and SVC, whereas a sensor with a modified cylindrical anchor with various struts was designed to reside in the IVC. Each implant was calibrated against a Millar catheter reference sensor. The ability of the central venous sensors to detect changes in pressure was evaluated by modifying the fluid volume of the animal. Results: The sensors implanted in both sheep were successful, which provided an opportunity to understand the relationship between PA and CVP via simultaneous readings. The mapping and implantation in the IVC took less than 15 minutes. Multiple readings were taken at each implant location using a hand-held reader device under various conditions. CVP recorded in the IVC (6.49 mm Hg) and SVC (6.14 mm Hg) were nearly the same. PA pressure (13-14 mm Hg) measured was higher than CVP, as expected. The SVC waveforms showed clear beats and respiration. Respiration could be seen in the IVC waveforms, but not all beats were easily distinguishable. Both SVC and IVC readings showed increases in pressure (3.7 and 2.7 mm Hg for SVC and IVC, respectively) after fluid overload was induced via extra saline administration. Conclusion: In this work, the feasibility of measuring CVP noninvasively was demonstrated. The established ability of wireless PA pressure sensors to enable prevention of decompensation events weeks ahead can now be explored using central venous versions of such sensors.

Changes in left ventricular shape and morphology in the presence of heart failure: a four-dimensional quantitative and qualitative analysis.

PURPOSE: The presence and progression of heart failure (HF) are associated with cardiac remodelling, defined as cellular, molecular and interstitial changes which occur after injury and manifest as changes in left ventricular (LV) size, mass, geometry and function. This research study was designed to investigate the changes to LV morphology and shape which occur in the presence of heart failure using three-dimensional (3D) modelling and analysis of cardiac-gated CT scans from both healthy individuals and patients classified with HF. METHODS: A number of quantitative and qualitative strategies were applied to cardiac CT scans of HF patients and healthy controls (n = 7) in order to analyse changes to LV size, shape and structure and to examine LV remodelling in the different classes of HF. Three-dimensional wireframe representations of endocardial and epicardial borders were created, three-dimensional computer stereolithography models of the inner LV cavity and myocardial wall segments were generated and three-dimensionally printed and a number of clinical LV dimension and shape indices were measured. All data were analysed using one-way ANOVA with post hoc Tukey method for multiple comparisons for significant variables. RESULTS: Results of most significance included abnormalities in LV mass and end-systolic dimensions and significantly increased septal wall thickness among mid-range ejection fraction cases. Also of importance were significant increases in both dimension-based and volumetric sphericity index measures in all HF cases. Three-dimensional printed models provided qualitative information as to changes in inner LV cavity and myocardial wall morphology across the cardiac cycle for healthy and HF cases and validated quantitative findings. CONCLUSION: Findings from this study can successfully be applied to motivate the research and development of new HF treatment strategies and devices as well as for the development of a realistic cardiac simulator system.

Multiband ultra-thin flexible on-body transceivers for wearable health informatics.

Substantial concentration has been associated to the monitoring of vital signs and human activity using wireless body area networks. However, one of the key technical challenges is to characterize an optimized transceiver geometry for desired isolation/bandwidth and specific absorption rate (SAR) characteristics, independent of transceiver chip on-body location. A microwave performance evaluation of monopole wearable transceiver was completed and results presented. A novel on-body antenna transceiver was designed, simulated and fabricated using an ultra-thin substrate RO 3010 (h = 250 µm) that ensures compactness and enhanced flexibility. The designed transceiver was evolved using very high value of dielectric constant using CST® Studio Suit and FEKO® numerical platforms. The on-body characterization for both fatty and bone tissues was experimentally verified for a bandwidth of 200 MHz. The fabricated configuration and real-time testing provides very promising microwave radiation parameters with a gain of 2.69 dBi, S11 < - 13 dB at an operational frequency of 2.46 GHz. Multi-banding was achieved by introducing fractals in the design of the printed monopole. SAR calculations for feet, head and arm at microwave power levels ranging from 100 to 800 mW are incorporated. Furthermore, the real time data acquisition using developed transceiver and its experimental verification is illustrated.

Recent Trends in Clot Retrieval Devices: A Review.

Stroke is the second leading cause of death worldwide and in Europe. Even with gold standard medical management of acute ischemic stroke, which is intravenous (IV) thrombolysis by administration of recombinant tissue plasminogen activator (rt-PA), the mortality rate remains the same. Intra-arterial (IA) thrombolysis therapy also did not achieve significant results and was not approved by the US Food and Drug Administration (FDA) because of limited sample size. This encouraged scientists and engineers to develop endovascular clot retrieval devices for the mechanical recanalization of the occluded arteries in stroke patients. Although the initial designs of clot retrieval devices failed, efforts to improve these devices continue. Recently clot retrieval devices were approved by the FDA as first-line treatment along with IV rt-PA. This article gives an in-depth review of different clot retrieval devices which includes MERCI (the first), the Penumbra Aspiration System, EmboTrap®II, stent retrievers, and the way forward with the new FDA clearance of the devices as first-line treatment for acute ischemic stroke along with IV rt-PA. The review also includes a comparison of clot retrieval devices to gold standard treatment.

Transseptal puncture - Review of anatomy, techniques, complications and challenges.

In recent years, the transseptal puncture approach has enabled passage of increasingly large and complex devices into the left atrium. Traditional tools remain effective in creating and dilating the initial puncture, with an acceptable safety profile. Even for skilled operators, the procedure is technically demanding and requires sound understanding of atrial anatomy. Intracardiac echocardiography is useful in cases of previous septal repair, poorly defined fossa ovalis anatomy or when considering patent foramen ovale portal crossing. Iatrogenic atrial septal defect (iASD) is the most commonly encountered long-term complication and there is increasing evidence that larger devices are leading to symptomatic defects. The size of the sheath crossing the septum is the strongest predictor of iASD formation but other factors such as longer procedure times, significant catheter manipulation and high pulmonary pressures also contribute. Transcatheter mitral valve repair involves the use of large 22 Fr catheters which carry alarmingly high rates of defect persistence with precipitation of symptoms and possible influence on mortality. Long-term follow up data, particularly beyond the 12-month period are lacking and resultantly, evidence to guide management is sparse. Refinements of conventional instruments, as well as innovations to puncture the septum without mechanical pressure, herald a progressively safer future for the transseptal technique.

Dual plasmonic gold nanostars for photoacoustic imaging and photothermal therapy.

AIM: To fabricate multimodal nanoconstruct that act as a single node for photoacoustic imaging (PAI) and photothermal therapy (PTT) in the fight against cancer. MATERIALS & METHODS: Dual plasmonic gold nanostars (DPGNS) were chemically synthesized by reducing gold precursor using ascorbic acid and silver ions as shape directing agent. PAI and PTT were performed using commonly available 1064 nm laser source on DPGNS embedded tumor xenografts on mice. RESULTS & CONCLUSION: Photoacoustic amplitude increase with longer wavelength source and with silica coating of DPGNS. The in vivo photothermal capability of DPGNS resulted in a significant decrease in the tumor cellular area. DPGNS exhibited potential for single node diagnosis and therapy with longer wavelength facilitating deeper imaging and therapy.

Functional imaging for regenerative medicine.

In vivo imaging is a platform technology with the power to put function in its natural structural context. With the drive to translate stem cell therapies into pre-clinical and clinical trials, early selection of the right imaging techniques is paramount to success. There are many instances in regenerative medicine where the biological, biochemical, and biomechanical mechanisms behind the proposed function of stem cell therapies can be elucidated by appropriate imaging. Imaging techniques can be divided according to whether labels are used and as to whether the imaging can be done in vivo. In vivo human imaging places additional restrictions on the imaging tools that can be used. Microscopies and nanoscopies, especially those requiring fluorescent markers, have made an extraordinary impact on discovery at the molecular and cellular level, but due to their very limited ability to focus in the scattering tissues encountered for in vivo applications they are largely confined to superficial imaging applications in research laboratories. Nanoscopy, which has tremendous benefits in resolution, is limited to the near-field (e.g. near-field scanning optical microscope (NSNOM)) or to very high light intensity (e.g. stimulated emission depletion (STED)) or to slow stochastic events (photo-activated localization microscopy (PALM) and stochastic optical reconstruction microscopy (STORM)). In all cases, nanoscopy is limited to very superficial applications. Imaging depth may be increased using multiphoton or coherence gating tricks. Scattering dominates the limitation on imaging depth in most tissues and this can be mitigated by the application of optical clearing techniques that can impose mild (e.g. topical application of glycerol) or severe (e.g. CLARITY) changes to the tissue to be imaged. Progression of therapies through to clinical trials requires some thought as to the imaging and sensing modalities that should be used. Smoother progression is facilitated by the use of comparable imaging modalities throughout the discovery and trial phases, giving label-free techniques an advantage wherever they can be used, although this is seldom considered in the early stages. In this paper, we will explore the techniques that have found success in aiding discovery in stem cell therapies and try to predict the likely technologies best suited to translation and future directions.

Coronary Stent Materials and Coatings: A Technology and Performance Update.

This paper reviews the current state of the art for coronary stent materials and surface coatings, with an emphasis on new technologies that followed on from first-generation bare metal and drug-eluting stents. These developments have been driven mainly by the need to improve long term outcomes, including late stent thrombosis. Biodegradable drug-eluting coatings aim to address the long term effects of residual durable polymer after drug elution; the SYNERGY, BioMatrix, and Nobori stents are all promising devices in this category, with minimal polymer through the use of abluminal coatings. Textured stent surfaces have been used to attached drug directly, without polymer; the Yukon Choice and BioFreedom stents have some promising data in this category, while a hydroxyapatite textured surface has had less success. The use of drug-filled reservoirs looked promising initially but the NEVO device has experienced both technical and commercial set-backs. However this approach may eventually make it to market if trials with the Drug-Filled Stent prove to be successful. Non-pharmacological coatings such as silicon carbide, carbon, and titanium-nitride-oxide are also proving to have potential to provide better performance than BMS, without some of the longer term issues associated with DES. In terms of biological coatings, the Genous stent which promotes attachment of endothelial progenitor cells has made good progress while gene-eluting stents still have some practical challenges to overcome. Perhaps the most advancement has been in the field of biodegradable stents. The BVS PLLA device is now seeing increasing clinical use in many complex indications while magnesium stents continue to make steady advancements.

Linear-array-based photoacoustic imaging of human microcirculation with a range of high frequency transducer probes.

Photoacoustic imaging (PAI) with a linear-array-based probe can provide a convenient means of imaging the human microcirculation within its native structural context and adds functional information. PAI using a multielement linear transducer array combined with multichannel collecting system was used for in vivo volumetric imaging of the blood microcirculation, the total concentration of hemoglobin (HbT), and the hemoglobin oxygen saturation (sO2) within human tissue. Three-dimensional (3-D) PA and ultrasound (US) volumetric scans were acquired from the forearm skin by linearly translating the transducer with a stepper motor over a region of interest, while capturing two-dimensional images using 15, 21, and 40 MHz frequency transducer probes. For the microvasculature imaging, PA images were acquired at 800- and 1064-nm wavelengths. For the HbT and sO2 estimates, PA images were collected at 750- and 850-nm wavelengths. 3-D microcirculation, HbT, and sO2 maps of the forearm skin were obtained from normal subjects. The linear-array-based PAI has been found promising in terms of resolution, imaging depth, and imaging speed for in vivo microcirculation imaging within human skin. We believe that a reflection type probe, similar to existing clinical US probes, is most likely to succeed in real clinical applications. Its advantages include ease of use, speed, and familiarity for radiographers and clinicians.

Feasibility of intracoronary frequency domain optical coherence tomography derived fractional flow reserve for the assessment of coronary artery stenosis.

Frequency domain optical coherence tomography (FD-OCT) provides cross-sectional images of coronary arteries and deployed stents with micron resolution and measures lumen dimensions with excellent reproducibility. FD-OCT combined with a blood flow resistances model can overcome many limitations of conventional measures of stenosis severity based on quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). The aim of this feasibility study was to investigate the relationship between pressure derived fractional flow reserve (FFR) and FD-OCT derived FFR, a new method for quantitative measure of stenosis severity that estimates the blood flow resistance and microvascular resistance of the vessel segments imaged by FD-OCT. A total of 26 coronary stenoses in 20 patients were studied consecutively with QCA, pressure derived FFR, and FD-OCT. There was a moderate but significant correlation between pressure derived FFR and FD-OCT derived FFR (r = 0.69, P < 0.001). Bland-Altman analysis showed that the mean differences between pressure derived FFR and FD-OCT derived FFR were 0.05 ± 0.14 (limits of agreement: -0.09 to 0.19). The root mean square error (RMSE) between FD-OCT derived FFR and pressure derived FFR was found to be ± 0.087 FFR units. FD-OCT derived FFR has the potential to become a valuable tool for the assessment of coronary artery stenosis.

Measurement of the blood flow rate and velocity in coronary artery stenosis using intracoronary frequency domain optical coherence tomography: Validation against fractional flow reserve.

OBJECTIVES: The main objective of this study was to assess the blood flow rate and velocity in coronary artery stenosis using intracoronary frequency domain optical coherence tomography (FD-OCT). A correlation between fractional flow reserve (FFR) and FD-OCT derived blood flow velocity is also included in this study. METHODS & RESULTS: A total of 20 coronary stenoses in 15 patients were assessed consecutively by quantitative coronary angiography (QCA), FFR and FD-OCT. A percutaneous coronary intervention (PCI) optimization system was used in this study which combines wireless FFR measurement and FD-OCT imaging in one platform. Stenoses were labelled severe if FFR ≤ 0.8. Blood flow rate and velocity in each stenosis segment were derived from the volumetric analysis of the FD-OCT pull back images. The FFR value was ≤ 0.80 in 5 stenoses (25%). The mean blood flow rate in severe coronary stenosis (n = 5) was 2.54 ± 0.55 ml/s as compared to 4.81 ± 1.95 ml/s in stenosis with FFR > 0.8 (n = 15). A good and significant correlation between FFR and FD-OCT blood flow velocity in coronary artery stenosis (r = 0.74, p < 0.001) was found. CONCLUSION: The assessment of stenosis severity using FD-OCT derived blood flow rate and velocity has the ability to overcome many limitations of QCA and intravascular ultrasound (IVUS).

Evaluation of hemodynamically severe coronary stenosis as determined by fractional flow reserve with frequency domain optical coherence tomography measured anatomical parameters.

OBJECTIVES: The main objective of this study is to determine the correlation between fractional flow reserve (FFR)- and frequency domain optical coherence tomography (FD-OCT)-measured lumen parameters, and to determine the diagnostic competence of FD-OCT concerning the identification of severe coronary stenosis. METHODS: A total of 41 coronary stenoses in 30 patients were assessed consecutively by quantitative coronary angiography (QCA), FFR, and FD-OCT. Stenoses were labeled severe if FFR ≤ 0.80. The minimal lumen area (MLA), minimal lumen diameter (MLD), and percent lumen area stenosis (%AS) were measured using FD-OCT. RESULTS: FFR was ≤ 0.80 in 10 stenoses (24.4%). A poor but significant correlation between FFR and FD-OCT-measured MLA (r(2) = 0.4, p < 0.001), MLD (r(2) = 0.28, p < 0.001), and %AS (r(2) = 0.13, p = 0.02) was found. In the overall group, the diagnostic efficiency of MLA and MLD in identifying significant stenosis was moderate. The area under the curve (AUC) was 0.80 [95% confidence interval (CI): 0.64-0.91] for MLA and 0.76 (95% CI: 0.60-0.88) for MLD. The best cut-off values of FD-OCT-measured lumen parameters to identify stenosis with FFR ≤ 0.80 were 1.62 mm(2) [specificity 97%, sensitivity 70%, positive predictive value (PPV) 89% and negative predictive value (NPV) 91%] for MLA and 1.23 mm (specificity 87%, sensitivity 70%, PPV 64% and NPV 90%) for MLD. The diagnostic efficiency of MLA in identifying significant stenosis in vessels having reference diameter < 3 mm was high. The AUC was 0.96 (95% CI: 0.83-1.0). CONCLUSIONS: The FFR values and FD-OCT anatomical parameters MLA, MLD were found to be significantly correlated. In the overall group, the FD-OCT-measured MLA and MLD have shown moderate diagnostic efficiency in the functional evaluation of significant stenosis. FD-OCT-measured MLA has high diagnostic efficiency in identifying severe coronary stenosis in vessels having reference diameter < 3 mm.